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RJ Reynolds

Steven R Arch, Et Al Vs. The American Tobacco Company, Et Al. Deposition of Harold I. Schwartz, M.D. Exhibits 1-12.

Date: 19 Feb 1997
Length: 477 pages
517706709-517707185
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Schwartz, H.I.
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3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Deposition of HAROLD I. SCHWARTZ, M.D., the witness herein, taken on behalf of the plaintiff herein, for the purpose of discovery and for use as evidence in this cause, pending in the United States District Court for the Eastern District of Pennsylvania, pursuant to Notice, before Judi A. Roberts, a Notary Public within and for the State of Connecticut, at the Sheraton Hotel, 315 Trumbull Street, Hartford, Connecticut on the 19th of February, 1997, at 10:25 A.M., at which time counsel appeared as hereinbefore set forth. .. IT IS STIPULATED AND AGREED by and between counsel representing the respective parties that the deponent will read and sign the deposition transcript. JUDI A. ROBERTS REPORTING SERVICE.
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2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 APPEARANCES: FOR THE PLAINTIFF: RODA & NAST, P.C. BY: ROBERT J. LAROCCA, ESQUIRE 408 Lombard Street Philadelphia, PA 19147 FOR THE PLAINTIFF: SHELLER, LUDWIG & BADEY BY: SHERRICE KNISELY, ATTY-AT-LAW 1528 Walnut Street 3rd Flr. Philadelphia, PA 19102 FOR PHILIP MORRIS: DECHERT, PRICE & RHOADS BY: WILLIAM K. DODDS, ESQUIRE 30 Rockefeller Plaza New York, NY 10112 FOR LORILLARD TOBACCO COMPANY, LORILLARD, INC., LOEWS, BROWN & WILLIAMSON, AMERICAN TOBACCO, BATUS, INC. & BATUS HOLDINGS; INC.: SHOOK, HARDY & BACON BY: SHANNON SPANGLER, ATTY-AT-LAW 1200 Main Street - 23rd Flr. Kansas City, MO 65101 FOR R. J. REYNOLDS COMPANY: JONES, DAY, REAVIS & POGUE BY: MICHAEL A. NIMS, ESQUIRE North Point 901 Lakeside Ave. Cleveland, OH 44114 FOR UNITED STATES TOBACCO COMPANY: SKADDEN, ARPS, SLATE, MEAGHER & FLOM, LLP - BY: ARTHUR F. FAMA, JR., ESQUIRE 919 Third Avenue New York, NY 10022-3897 JUDI A. ROBERTS REPORTING SERVICE
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4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Thereupon: HAROLD I. SCHWARTZ, M.D., being first duly sworn, as hereinafter certified, was examined and test'ified as follows: DIRECT EXAMINATION BY MR. LAROCCA: Q. Say your full name for the record, please. A. Doctor Harold I Schwartz. MR. LAROCCA: Off the record. (Off the record discussion) MR. LAROCCA: Back on the record. (Schwartz Exhibit 1, Notice of Deposition, marked for identification) Q. (By Mr. Larocca) Doctor Schwartz, let me show you an exhibit that we've marked as Schwartz No. 1. This is the Notice of Deposition for your deposition today, and attached to it is a Schedule A of documents that we requested be produced. And there were a number of documents produced to us this morning at the time, at ten o'clock. Can you tell me the process by which you assembled the documents in response that this request? MR. NIMS: Just before he does that, let me make a statement so the record is JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 5 clear. We received this, I guess Friday, although no one saw it on Friday; we saw it on Monday. I attempted to contact Dr. Schwartz on Monday and they were closed for the holiday on Monday, so my contact with Dr. Schwartz about this occurred on Tuesday. And the documents that were assembled were, therefore, assembled on one day's notice and represent the best attempt to comply that could be done in one day. We have produced documents respecting this case and documents respecting things that Dr. Schwartz has done which conceivably relate to what he relies upon in this case. We have not made an attempt to assemble all documents that exist with respect to cases on which we have consulted with Dr. Schwartz through the years and which he has not been designated as an expert. And we would object to producing things from cases in which he has not been designated as an expert. JUDI A. ROBERTS REPORTING SERVICE
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UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA * * * * * * * * * * * * * * * * STEVEN R. ARCH, ET AL, Plaintiff VS. * * Civil Action No. 96-5903-CN * THE AMERICAN TOBACCO COMPANY, * ET AL, Defendant * * * * * * * * * * * * * * * * * Hartford, CT February 19, 1997 10:25 A.M. DEPOSITION OF HAROLD I. SCHWARTZ, M.D. JUDI A. ROBERTS REPORTING SERVICE 85 VISCOUNT DRIVE NO. 15F MILFORD, CT 06460 (203) 876-7018 II ~ ~ad:SK..: JUDI A. ROBERTS REPORTING SERVICE 1
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7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Dr. Schwartz from the period of January 1st, 1992 to the present. And we don't see any other resumes produced here this morning; is that correct? A. Resume, you mean other than my current resume? Q. Other than the one that's attached to the affidavit that you submitted in this case, which is dated June the 13th, 1994. A. That's correct. I've only submitted one curriculum vitae, which is the one attached. Q. So your testimony is, Dr. Schwartz, there's nothing in existence, any other earlier version before this one of June the 13th, 1994 that's attached to your affidavit? A. I haven't submitted any. I didn't realize that you were requesting curriculum vitaes from times earlier than that, but I might have earlier curriculum vitaes. They get revised from time to time as I publish a new article or whatever. They are revised on a disc, so I'm not particularly concerned with keeping a hard copy of them, but I could go back and look and see if I have older resumes. Q. If you could, we'd appreciate that. A. Sure. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 9 identification) Q. (By Mr. Larocca) If you'd look at the last page of that, please. A. (Witness complying) Q. Do you see the last line? A. Yes. Q. And I'll read it again for the record. Quote: "The role of addiction versus motivation to quit smoking in actions against tobacco manufacturers." Were you involved in consulting for the tobacco companies as of June 13, 1994? A. In consulting, yes. Q. when did you first begin consulting to the tobacco companies? A. It was in the late 1980's. I can't give you a precise date, but my best estimate it was '86 or '87. Q. How did that come about? A. I received a telephone call from an attorney representing one of the tobacco companies who had gotten my name from somebody I had worked with on a case unrelated to tobacco litigation asking me if I would be interested in discussing this issue with him, and I was interested in talking JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 6 And the only other comment generally, I guess I would make, is that the production request referenced the Stewart-Lomanitz case, which actually did not ring a bell with us because we think of that as the Hoskins case, and, therefore, there are documents respecting the New York case that we didn't assemble. And since he has been designated as an expert on that, I won't object to questions about that case, and we are getting that file together and he's going to be deposed in three days. But I don't have all of the Hoskins documents with us today because the Stewart-Lomanitz case, we didn't realize that that was the same case as the Hoskins case. MR. LAROCCA: Okay. I appreciate the effort that both of you made to assemble these documents on what I realize is short notice. Q. (By Mr. Larocca) One set of documents that we didn't see when I looked at it. No. 1: All C.V.'s or resumes prepared by or concerning JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 8 Q. And so your testimony is, Dr. Schwartz, that the revised as of June the 13th, 1994, that's attached to the affidavit that you submitted in this litigation, is the most current version? A. No, no, I have a more current version than that. I don't know why that's the version, that date would be the one that's attached to that. That, I definitely have, and can provide to you. Q. Okay. I notice on this resume it says June 13, 1994, in the last entry it says: "Forensic Consultation and Expert Witness Testimony". And the last line says: °Role of addiction versus motivation in actions against tobacco manufacturers." And this is dated as of June the 13th 1994; is that correct? A. Yes. I am not seeing what you're referring to. Q. I will show you the -- MR. LAROCCA: In fact, let's mark this Schwartz Exhibit No. 2, the affidavit and curriculum vitae that Dr. Schwartz submitted in this litigation. (Schwartz Exhibit 2, Affidavit and Curriculum vitae, marked for JUDI A. ROBERTS REPORTING SERVICE .
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 13 A. The case is familiar, and I believe that I was consulted in some capacity. Q. But you don't believe that you submitted an expert report to the Court? A. All I can tell you is that the case is familiar. I don't have a distinct impression of it. MR. LAROCCA: Let me mark Schwartz Exhibit 3. (Schwartz Exhibit 3, Article from the New York Law Journal, marked for identification) MR. LAROCCA: This is an article printed out from the New York Law Journal dated January the 9th, 1992. Q. (By Mr. Larocca) Doctor Schwartz, if you'd look at the first page, you see half way down "Judge G. Weisberg," "Matter of Davis"? A. Yes. Q. All right. Would you turn to the second page, and do you see the second full paragraph. Let me read it into the record. It says, "In reply, Claimant submitted the affirmation of Dr. Harold Schwartz, a physician licensed in the State of Connecticut." A. Excuse me, I don't have the second page JUDI A. ROBERTS REPORTING SERVICE .
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14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 here. Q. You don't. I'm sorry, it's page -- you're right. It says page 4 at the top; it's actually page 2 of this opinion. A. There's no paragraph that starts "in reply" on this page. Q. Let me start over again. I was confused because I started in the middle of that paragraph. It's the paragraph that reads as follows: "As to an appearance of merit, claimant's initial motion papers did not include an expert affidavit of merit. When defendant raised this defect, in reply the claimant submitted the affirmation of Dr. Harold Schwartz, a physician licensed in the State of Connecticut. Doctor Schwartz opined that based on his review of Ms. Boyd's medical records that her discharge on February the 1st, 1991 would, 'appear' to have, 'constituted deviations from commonly accepted psychiatric and hospital practice. .. which bears a causal relationship with the injuries which the patieDt subsequently received." Do you see that paragraph? A. Yes I do. Q. Are you the Harold Schwartz that's described in that paragraph? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 12 A. Yes. Q. In another lawsuit? A. Yes. Q. Where you were an expert witness? A. Yes. Q. Have you ever had an expert opinion or report that you have authored rejected by a court on the grounds that it didn't have a sufficient basis or expertise? A. No. Q. Were you an expert retained by an expert in a case called "Matter of Davis" in New York involving a woman who jumped in front of a subway train? A. It's possible. I can't say for sore. Q. Let me describe the circumstances a little bit more. She had been released from a mental hospital, and her mother brought -- she jumped in front of a subway train in New York and her mother brought an action against the mental hospital for negligence; is that ringing any bells for you? A. That sounds familiar, yes. Q. You think you were retained as an expert in that case? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 15 A. I guess I am, yes. Q. Now, does this -- you testified that you couldn't recall having submitted an expert report. Does this refresh your recollection, Dr. Schwartz? A. Barely. Q. Barely. And then if we go on over, it says -- let me read into the record the last paragraph of that page. It says: "While the instant affirmation is not as bad, it also suffers from several of the same defects. It does tell us what the departure was: Ms. Boyd's release on February 1. However, we are offered no other facts or standards with which to access Dr. Schwartz's conclusion that the release was improper. It is totally conclusory without factual or objective support and is therefore unacceptable." Does that refresh your recollection, Dr. Schwartz, that your opinion has ever been rejected by a court? MR. DODD: Objection. A. I'm not sure what you mean by has my opinion ever been rejected by a court. Do you mean have courts always agreed with my opinion? Q. (By Mr. Larocca) No. Let's go back to the question that I asked you starting -- JUDI A. ROBERTS REPORTING SERVICE
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16 1 MR. LAROCCA: Could I have that read 2 back, please. 3 (Whereupon, the question: "Have you 4 ever had an expert opinion or report that 5 you have authored rejected by a court on 6 the grounds that it didn't have a 7 sufficient basis or expertise?" was read 8 by the reporter) 9 Q. (By Mr. Laroccaa) Have you heard that 10 uestion read back Dr Schwartz? q , . 11 A. I have not been paying attention. I'd 12 like to read this report before I answer the 13 uestion q . 14 Q. Certainly. Take as much time as you need 15 and t hen tell me when you've finished and I'll ask 16 the c our t reporter to read back the question again. 17 A. (Doctor read ing report) Okay, I'm 18 finis hed . 19 (Whereupon, the question: "Have you 20 ever had an expert opinion or report that 21 you've authored rejected by a court o n 22 the grounds that it didn't have a 23 sufficient basis or expertise?" was r ead 24 by the reporter) 25 Q. (By Mr. Larocca) Do you wish to change Ln ~ ~ ~ m JUDI A. ROBERTS REPORTING SERVICE
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11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Q. Do you know approximately the total aggragate bills that you've submitted to R. J. Reynolds for that work over the last decade? MR. NIMS: Just for the record, bills would have been submitted to Jones, Day. MR. LAROCCA: Fine, I'll take that correction. A. And I consider myself to be consulting to Jones, Day, Reaves & Pogue and not to R. J. Reynolds. It is a broad approximation, which is to say I haven't gone back to figure this out; I really don't know for sure. My guess would be forty to $50,000. Q. (By Mr. Larocca) Have you given any depositions before today in an action that involved a tobacco company? A. No. Q. Have you testified in any court proceeding in a case that involved a tobacco company? A. No. Q. Have you ever had your deposition taken before at all? JUDI A. ROBERTS REPORTING SERVICE
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10 I 1 about it. 2 Q. Do you remember which attorney it was? 3 A. I'm not positive. 4 Do you remember which firm? 5 A. It was Jones, Day, Reaves & Pogue. 6 Q. Do you remember which tobacco company you 7 were being asked to work for? 8 A. It was R. J. Reynolds. 9 Q. Have you worked continuously for R. J. 10 Reynolds from that time up to the present? 11 MR NIMS Ob ti . : jec on. 12 Q. (By Mr. Larocca) You can answer. 13 A. I" ve worked intermittently from that 14 time to the resent p . 15 Q. What do you mean when you use the word 16 "intermittent"? 17 A. Well, I would do some consulting at a 18 particular point in time and then might not do 19 anything for six months , and I mi ght be asked to 20 look at something else; it would be off and on. 21 Q. Would it be fair to say for some portion 22 of every calendar year since, let's say 1987, you've 23 been asked to do some consulting work for R..J. 24 Reynolds? 25 A. Yes. -a JUDI A. ROBERTS REPORTING SERVICE
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i 19 i 1 fr om rec ord. Whether something has been 2 re jected for lack of expertise, I believe 3 th e witn ess appropriately answered the 4 qu estion . 5 MR. LAROCCA: Let's hear the i 6 qu est on . 7 MR. DODD: Let me interpose an 8 ob jectio n. Lack of foundation. 9 Q. (B y Mr. Larocca) Did you hear the 10 question, Doctor? 11 A. Ye s, I did. 12 Q. Yo u heard the words at the end of the 13 question; it says -- how did you hear that question; 14 what did you hear it asking you? 15 MR. NIMS: Objection. 16 A. I'm s orry, what is it you're asking me? 17 Q. (By Mr. Larocca) Having heard the 18 question again, do you wish to change your answer? 19 Lack of DODD: Objection MR . . 20 foundation. 21 A. Again, I will repeat, that this is the 22 first time I'm seeing this report. 23 It is true that the Judge found that, in 24 his view, I did not include sufficient supporting 25 evidence for my opinion to justify the opinion that ~ ~ JUDI A. ROBERTS REPORTING SERVICE
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1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is Q. Let's look at his words. He says at the bottom of the second page: "However, we are offered no other facts or standards with which to access Dr. Schwartz's conclusion that the release was improper. It is totally conclusory without factual or objective support and is therefore unacceptable." Do you see those words? A. Yes, I do. Q. Okay. I want you to listen one more time to the question I asked you before and your prior answer, and now that you do have in front of you what Judge Weisberg -- now that you do know about this and are aware of it, I'm asking you whether you'd like to change your answer or not? MR. LAROCCA: Would you please read back to the witness the question and his prior answer. (Whereupon, the question and answer, "Have you ever had an expert opinion or report that you've authored rejected by a court on the grounds that it didn't have a sufficient basis or expertise? Answer: No.°, were read by the reporter) MR. NIMS: And the question will obviously remain, since we're reading JUDI A. ROBERTS REPORTING SERVICE ,
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22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 question is "no"; is that right? A. I have answered the question three or four times. You've asked it three or four times, and I guess each time you've asked it I have answered it, and I stand by every answer. Q. You understand your obligation to tell the truth in this deposition, don't you? MR. NIMS: Objection. A. Yes, I do. Q. (By Mr. Larocca) What is your understanding of the oath that we're talking about? MR. NIMS: Objection. You don't have to answer that. If you have questions you wish to put to the witness which are appropriate, we will proceed, but we're not going to have you lecture on your belief as to what the oath means. MR. LAROCCA: I'm not lecturing on questions. The pretrial order of the Judge, which your colleague has envoked on numerous occasions, makes it quite clear that speaking objections are not permitted. MR. NIMS: Well, I have read the JUDI A. ROBERTS REPORTING SERVICE
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17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 your prior answer, Dr. Schwartz? THE WITNESS: What was my prior answer? COURT REPORTER: "No." A. My prior answer would remain the same. First of all, this is the first time that I am seeing this report on that particular case. Q. (By Mr. Larocca) You're referring to Schwartz 3? A. Yes, Schwartz 3. Q. Okay. So your testimony is that you never knew before this morning, when I showed you this article from the New York Law Journal, that Judge Weisberg had made the finding about your affirmation that he did? A. That's correct. My testimony is that also I don't agree with your characterization of the Judge's finding. Q. I see. How would you characterize it? A. This is not a finding that I do not have sufficient expertise. This is a finding that the Judge does not believe I included enough supporting evidence in my opinion, therefore that he found that opinion to lack weight and rejected it on that basis. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 24 A. Frankly, I object to the question also. My understanding of telling the truth means what it says; telling the truth; speaking the truth. Q. (By Mr. Larocca) What do you understand the truth to include? MR. NIMS: Do you have a philosopher's definition you wish us to consider, or can we assume that the witness has told you four times that he had not,been aware until you showed him this that a judge had said this about an opinion. Having read it, he's answered as best he can what it appears to him the Judge said. Q. (By Mr. Larocca) Well, you spoke in your affidavit that you submitted in that case that patients frequently lie. Don't you say that they don't tell the truth? MR. NIMS: I object to that. And the affidavit speaks for itself. But I do not believe there's any statement in there that says that patients frequently lie. Q. (By Mr. Larocca) Do you recall saying anything in your affidavit about patients not JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 21 that -- Q. No, just the words. What do the words "a sufficient basis" mean to you? A. A sufficient basis of what; what are we talking about? Q. Your answer is: you don't understand what the words mean? A. If you want to narrow the question asking me about a basis, sufficient basis; a sufficient basis to render an expert opinion on psychiatric matters? If that's what you're talking about, I can tell you what that means. Q. Do you think that Judge Weisberg, in the opinion that we have marked as Schwartz No. 3, concluded that your expert affirmation lacked a sufficient basis? MR. DODD: Objection. MR. NIMS: If you have any basis for knowing what the Judge concluded, other than what you've been asked to read. A. All I know from what I've read is he felt I didn't support my opinion with sufficient data to justify its conclusion. Q. (By Mr. Larocca) So you're standing on your prior answer under oath that the answer to my JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 27 psychiatric facilities that do joint programs and market themselves together. MR. LAROCCA: Now, you have produced for us today, in response to my request, some brochures about the Institute of Living, and I'd like to mark those for the record, if I could. First will be Schwartz No. 4, which is a brochure entitled "The Institute of Living, A Comprehensive System of Care". (Schwartz Exhibit 4, Brochure, marked for identification) MR. LAROCCA: I'd like to mark as 5-A, B, C, et cetera, a series of one page descriptions of particular programs. (Schwartz Exhibits 5A through J, One page descriptions of particular programs, marked for identification) Q. (By Mr. Larocca) Doctor Schwartz, could you identify for us Exhibit 4, please? A. This is a brochure about the Institute of Living. Q. Is it the only brochure that you publish describing the Institute of Living? A. I actually couldn't say that for sure. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 would you put that in front of you, please. A. (Witness complying) Q. And you state in the first sentence that you're the Vice-President for Clinical Affairs and Medical Director of the Institute of Living, Hartford Hospital's Mental Health Network. How long have you held that position? A. Since 1994. Q. And could you just very briefly and generally describe the work of the Institute of Living. A. The Institute of Living is a mental health care facility. I guess the easiest way to think about it is being a portion of a hospital. It is a psychiatric hospital with an in-patient-unit, with day hospital unit, with out-patient programs, residential programs, in-home programs, et cetera. Until 1994 the Institute was a very, very large, in fact, one of America's largest private psychiatric facilities. At that time in 1994 it consolidated or merged into Hartford Hospital, which is a large general hospital in northern Connecticut. And so it currently functions as the psychiatric division of a large general hospital. It's also the linchpin of developing a state-wide network of Ln r ~ J m m J W JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 23 transcript in the deposition of Dr. Burns, and I will be guided by the understanding apparently indicated by the lawyers who were present at that deposition, but I certainly will attempt to comply with all orders of the Judge, but we're not going to have the witness insulted by what the oath means. MR. LAROCCA: Are you directing him not to answer my question? MR. NIMS: I see no point in it. You're asking if he understands what to tell the truth means. And, yes, I am saying that he need not answer that question. MR. LAROCCA: Are you instructing him not to answer the question? MR. NIMS: No, I'm not instructing him not to answer the question. Q. (By Mr. Larocca) would you please answer the question. A. It seems to me it means what it says. Q. What is your understanding of telling the truth mean? MR. NIMS: Objection. JUDI A. ROBERTS REPORTING SERVICE,
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31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 like Smoke Enders, so I think it's probably not completely true. Q. For those employees of the hospital, you're saying? A. Yes. Q• But it offers no program, as a hospital for patients, of a smoking cessation program; is that correct? A. As I said, the Department of Cardiology, in conjunction with some of the clinicians from the Institute of Living, is in the development of such a program. I actually can't say at what stage currently that program is at or whether they've actually treated any patients yet. Q. Are you involved in the development of this program? A. Peripherally. Q. What is your development? A. Ultimately I have to approve the use of resources for any program development that we're engaging in, and I have clinical responsibility ultimately for all of our programs. Q. Now, let's look back at your affidavit, Schwartz Exhibit No. 2. I direct your attention to paragraph two, the last sentence; let me read that JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 33 recovery service at the Institute, that's the portion or the wing of the Institute that deals with all of the substance abuse programs, correct? A. Yes. Q. You're taking this affidavit to talk about your qualifications with nicotine addiction or nicotine dependence, correct? MR. NIMS: Objection. Is that a question or -- MR. LAROCCA: Yes, it certainly is; that was a question. Did you understand the question? THE WITNESS: Would you repeat it. MR. LAROCCCA: Would you read it back. (Whereupon, the question, "You're taking this affidavit to talk about your qualifications with nicotine addiction or nicotine dependence, correct?" was read by the reporter) A. That is not the primary way that I would characterize my role in this affidavit. I would characterize my role as a discussion of the issues of motivation to change behavior, commitment to the change in behavior, and the various factors of JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 30 Institute for Living, in terms of the programs that you offer, offers no program for nicotine addiction, correct? A. It offers no program for treating the smokers, that's correct. Q. Well, why do you, when I asked you the question about addiction, you changed the answer for treating smokers? A. If we were to offer such a program, that would not be the label or the name for such a program which I would apply. I think there are better terms for it. We are in the development of a program at Hartford Hospital to treat certain patients at Hartford Hospital programs; it's in the early stages of development. Q. But the Hartford Hospital, which is affiliated with you, has no current program for nicotine addiction, does it? A. Not to my knowledge. Q. Okay. And it has no program for treating smokers, correct? A. I actually can't say that for sure. We have a kind of employee lifestyle health service that I believe has offered Smoke Enders or a program ! JUDI A. ROBERTS REPORTING SERVICE
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32 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 into the record. Quote, "For example, the addictiop recovery service at the Institute of Living consists of eight substance abuse/mental health professionals, in addition to support staff, providing assessment and treatment to hundreds of patients with addiction/dependence disorders during the course of any year." Unquote. Have I read that correct? A. Yes. Q. Why didn't you say that nicotine addiction and smoking treatment was not one of the programs that you treated? MR. NIMS: Objection. A. This statement describes the services at the Institute of Living for which I am responsible. Addiction recovery service is one of those. These are the number of people roughly and the number of patients who work in that service. My responsibility for that service leaves me in relation to a subject that is of relevance here, that is, the subject of substance dependency. I feel that that is very relevant, and that's the point that I was making. Q. (By Mr. Larocca) Just so we're clear from your answer. When you refer to the addiction JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 34 personal choice, personalities, which altogether compound around the issue of how people change their behavior and in the face of what we think of as substance dependencies. Q. (By Mr. Larocca) Well, you talk throughout this affidavit about nicotine addiction and nicotine dependence, correct? MR. NIMS: Objection. A. I believe that I talk about nicotine dependence; that is correct. Q. (By Mr. Larocca) Didn't you think it was important to tell the Court that the Institute of Living has no program for nicotine dependence? MR. NIMS: Objection. A. I'm sure that you will take the opportunity to parse out exactly what the Institute of Living does or doesn't do, as you see it relevant to my af f idavit . What I see as relevant is my personal experience as a physician. My personal experience as a physician in dealing with individuals that have dependencies, my knowledge of factors that go into decisions about changing behaviors, motivation, commitment to change behavior, et cetera, and apparently in this particular paragraph I did not JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 25 telling the truth? A. I think my affidavit refers to the way in which patients distort reports of their smoking behavior and distort reports of their attempts to stop smoking. I don't believe the affidavit uses the word -- I'm almost certain the affidavit does not use the word "lie° and does not use the phrase "does not tell the truth". The concept of distortion is different. Q. When I'm asking you the questions and you're under oath to tell me the truth, I want to know what you mean by the truth in light of what you just said that distortions are different. MR. NIMS: Is that a question? Q. (By Mr. Larocca) How is a distortion different than not telling the truth or a lie? A. Distortions, as I use the term in my affidavit, refer often to mental phenomena that are not necessarily consideration on the one hand or that may be preconsideration, meaning they are somewhere between full consciousness and outside of awareness. Distortion also includes conscious manipulation of the truth. Q. Doctor Schwartz, I'd like to go back to your affidavit with regard to Schwartz Exhibit 2; JUDI A. ROBERTS REPORTING SERVICE
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20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 he could not find so he could settle. There is absolutely nothing in his statement that he felt I lacked expertise. In fact, in an earlier portion of Schwartz 3 the Judge clearly accepts that he accepts me as an expert witness in this case. MR. LAROCCA: Could I have the question read*back one more time, please. Q. (By Mr. Larocca) Doctor Schwartz, I'd like you to listen very hard this time to the last five words of the question. Would you do that for me? A. Yes. Q. Thank you. (Whereupon, the question: "Have you ever had an expert opinion or report that you've authored rejected by a court on the grounds that it didn't have a sufficient basis or expertise?" was read by the reporter) Q. (By Mr. Larocca) I'd like to direct your attention and concentrate on the phrase, °a sufficient basis"; do you know what that means? A. I believe that I do. Q. what is your understanding of that? A. My understanding is that the Judge felt N ~ ~ m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 It's certainly the main brochure which we have and send out to folks who want information about us. Q. Could you describe for us the various documents that comprise 5A through J? A. These are the inserts that go into the brochure that describe different programs in more detail. Q. When you look at those in their totality, is that the totality of programs that you offer at the Institute for Living? A. It's a little bit out of date, actually. This was developed probably at least a year or two ago so it's close, but not completely in totality. Q. What programs are omitted; what would you have to add to make that a complete description of the Institute of Living? A. I'd have to read each of these in detail to answer that precisely, but one pops out; there's a page on residential services. We have a new residential service for children and adolescents; it's funded by the Division of Child and Family Services of Connecticut; that's not here. We have a new kind of service called Intensive Out-patient Services that have replaced many of our out-patient programs; we don't have a JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 35 feel that relevant to write this particular paragraph the way you would have liked me to write it. You don't have to raise your voice. A. I wasn't aware that I was raising my voice. Q. So your testimony is that you were taking this affidavit as a personal affidavit, not trying to get any mileage from a description of the Institute of Living as a substance dependent treatment center? MR. NIMS: Objection. A. My assumption is, you'd like to know who I am, and I think that's why you've asked me for my curriculum vitae. And I am taking the opportunity to tell you and the Court who I am. Who I am is the clinical chief of a major psychiatric and substance abuse service delivery facility. I think it's very relevant to say that. Q. (By Mr. Larocca) In light of the colloquy we've had for over the last five minutes, and looking again at the paragraph two, the last sentence; if you had it to do over again, would you advise the Court that, while you have eight substance abuse mental health professionals at the JUDI A. ROBERTS REPORTING SERVICE
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29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 sheet on that. I don't think there are terribly significant changes. Q. Doctor Schw*rtz, am I correct that the Institute of Living has no program to treat people who are addicted to nicotine? MR. NIMS: Objection. A. we have no smoking programs, that is correct. Q. (By Mr. Larocca) You have never treated a smoker who wishes to cease smoking and claims that he or she can't stop smoking; isn't that correct? MR. NIMS: Objection. A. I'm sorry, are you asking me whether I personally? Q. (By Mr. Larocca) The Institute of Living, to the best of your knowledge, has never treated that kind individual? A. I can't say that for sure. Except and apart from our formal programs we have many, many practitioners who engage in out-patient psychotherapies, for instance, when somebody could have presented with that complaint and asked for treatment, and I really wouldn't know that. Q. Okay. But we're clear though that the JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 38 which produce some physiologic responses which can be characterized as dependency, but they are significantly and vitally important from the effects which are used, which are thought of as characterizing dependency in other substances. Q. I think you may have misspoken. MR. LAROCCA: Could we have that answer read back so I will be clear and you can be clear as to what you said and what she took down. (Whereupon, the answer, "I feel that nicotine has some effects of which produce some physiologic responses which can be characterized as dependency, but they're significantly and vitally important from the effects which are used, which are thought of as characterizing dependency in other substances" was read by the reporter) A. You are correct; that should say they are significantly and vitally different from those effects which are characterized as dependency in other substances. Q. (By Mr. Larocca) Could you elaborate on your view, please; what are the other substances JUDI A. ROBERTS REPORTING SERVICE.
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 39 you're referring to and how is nicotine different? A. Other subtances would be substances, such as opiates for which heroin would be a good example; alcohol, cocaine, stimulants and barbituates. Q. Just so I understand your testimony, Dr. Schwartz. Those substances that you've just enumerated are over in one corner and nicotine is distinguished from all of those? A. Nicotine is distinguished in some very important ways. Q. From all of those? A. Sometimes in different ways. Q. Please tell me how it's distinguished from each of those or all of those. A. Okay. Features of dependency that are commonly described with regard to various substances include the development of tolerance. Q. Now, I'm sorry, just so we're clear. I don't want to interrupt you, but are you describing now the opiates, alcohol, cocaine, stimulants, barbiturate group as a whole, when you start talking about tolerance? I want to be clear what your answer is referring to. A. My answer was referring to a generic phenomenon that people sometimes speak of when they JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 37 that the Institute for Living has no program for nicotine dependence or nicotine addiction, "yes" or I'no°? A. I will answer again; that that is a distortion of how an affidavit like this is written, according to the way in which you would like to see it written. I wrote this paragraph to establish something about what it is that I do. What I do in large part is to run this organization which provides a fairly significant amount of substance abuse and dependence treatment. People who are treated within these substance abuse programs have their tobacco dependencies addressed. They don't have them addressed in any formal program per se that addresses that issue under that heading; I think that's relevant. Q. Do you agree with me that cigarettes are addictive? A. I think that is a very poor choice of a word for characterizing the effects of tobacco. Q. Do you think that nicotine in cigarettes causes a form of drug dependency? A. I feel that nicotine has some effects of JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 42 different from these other classes? A. I'd like to go back to paragraph seven for just a moment. Q. Be my guest. A. I use the term "dependence" as though that obviates the point that I was just making, which it doesn't. I'm not saying that there doesn't seem to be a dependence to nicotine. I'm saying that the dependence to the degree to which there is dependence with regard to cigarettes is a more complicated matter than I believe that the tobacco dependence, which was a term used by the American Psychiatric Association in either the DSM-III or DSM-IV; DSM-III-R, excuse me. Q. Capital R. A. I believe that that term is more precise because I don't believe that nicotine explains all of the phenomena which are thought of as dependency phenomena around smoking. Q. Now, shall we go back to your -- you enumerated, as I understand it, there are five differences between nicotine on the one hand and opiates, alcohol, stimulants, cocaine and barbiturates on the other hand? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 36 Institute for Living, and you have this addiction recovery service, and that you treat hundreds of patients with addiction dependence disorders during the course of any year, that, in fact, none of those patients and none of those mental health professionals work on nicotine dependence? MR. NIMS: Objection. MR. DODD: Objection. Argumentative. MR. LAROCCA: You can answer. MR. NIMS: It would be interesting to hear that from Dr. Burns. A. First, I feel that's a mischaracterization of what the Institute of Living does and doesn't do. Secondly, if I had it to do over again, I'd write my own affidavit; not the affidavit that you would like me to write. Q. (By Mr. Larocca) I wouldn't like you to write any affidavit except the truth, Dr. Schwartz. A. Well, I am writing the truth. It would seem from the colloquy of the last five minutes that you'd like me to write your version of the truth. Q. I'm just asking, as you sit here today, you don't think it's important to tell the Court JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 44 cigarettes who may claim to be dependent or not, but many who do claim dependency -- Q. Doctor Schwartz, I think we're getting a little off focus here. MR. DODD: Let him answer. A. -- who do not demonstrate distress or disabilities; that would be one important difference. Q. (By Mr. Larocca) So how would you, in terms of the -- trying to go down the list you made of tolerance, withdrawal, how you acquired it, your sense of urgency, and your abstinence or quitting; which of,the ones that you just talked about, which of those five is that, or is there a sixth difference? A. Well, as I said, this is not a complete list. Q. Fine. A. If you go to DSM-IV and you look at how you make the determination that people do or don't have a dependency, you have to start with that over-arching concept; it's an over-arching concept. Q. Fair enough. The first one you mentioned was tolerance? A. Yes, I prefer to speak about withdrawal. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A. 43 MR. NIMS: Objection to the characterization of the five as being the universe. This was not a complete list. ~ Q. (By Mr. Larocca) Well, the five you've enumerated. A. There are others. And why don't we, as long as we're talking about the DSM -- why don't we use the DSM-IV and review all of the characteristics which the DSM-IV enumerates and I'll tell you how all of them are the same or whatever. Q. I'd just rather have you do it as you're sitting here, and if you want, your counsel can -- I'm really interested in your understanding, as you sit here, of how nicotine dependence differs from these other dependencies; that's all. MR. NIMS: Objection. A. Well, first of all, to back up a little bit, and using the DSM-IV as a reference for this particular discussion. . To qualify for the diagnosis of a nicotine dependence in the DSM, one must experience significant distress or disability as characterized by a number of symptoms that are then enumerated. And there are many individuals who smoke many JUDI A. ROBERTS REPORTING SERVICE.
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45 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Q. Well, I prefer to ask you in order, so tell me how nicotine dependency, tolerance for nicotine dependency is different from, in your opinion, tolerance for opiates, alcohol, cocaine, stimulants and barbiturates. A. Okay. A. Tolerance, in general, as a concept, meanrp the body's or the mind's, since tolerance may also in part be a psychological adaptation to that substance, such, that a person who might start out using a small amount of the substance, generally winds up using a larger amount of the substance to obtain the same effect. There are a number of differences between nicotine and smoking and other drugs in that regard. For one, there appears to be a pattern of accommodation to smoking or to nicotine that occurs on a daily basis with nicotine, which is unlike patterns of tolerance that occur with other substances. For another; while individuals begin their smoking experience -- everybody has to start the experience of taking a drug, whatever drug it might be, or using a substance, whatever substance it might be, with a single dose; everybody's got to JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 48 again, the body doesn't seem to ever develop a capacity to prevent a significant overdose. Q. Let's talk'about the second distinction, withdrawal. Could you distinguish what your view is as to the distinction between nicotine dependence on the one hand and the other drugs?. MR. NIMS: Objection. MR. LAROCCA: What's your objection? MR. NIMS: To your continued use of nicotine dependence as part of what he's answering. MR. LAROCCA: I see. A. I do prefer to speak of tobacco dependence. The literature indicates a compilation of symptoms which people often report, but not always, when they abstain from cigarette smoking. The syndrome, if we can call it that, which is constituted by this collection of symptoms, includes dysphoria, insomnia, sometimes irritability, sometimes an increase in anger, increase in appetite, weight gain. These symptoms are not experienced by all people who abstain from smoking, even people who may be smoking significant . numbers of cigarettes per day. Ln ~, -J 0 JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 47 the diagnosis of alcoholism. Now, that individual, when he started drinking, probably couldn't have tolerated five or six drinks; may have tolerated five or six drinks and became drunk or significantly intoxicated. Somewhere down the road he's able to tolerate five or six drinks without becoming so overtly drunk, but continues with that pattern often until times of significant stress, when the pattern may continue to escalate in many fold, and may, in fact, continue to a point at which the use of the drug is toxic, poisonous and may cause unconsciousness and even death. So another very significant difference is the development of a level may be a much higher level at which the level a person started, & level that remains stable with no capacity to overdose in a way that significantly affects consciousness and can lead to death. As compared to other substances: barbiturates, alcohol, heroin, which follow a pattern in which the individual may achieve a high level dose on a regular basis and be stable and may continue under particularly stressful circumstances to use more and more and more. There's almost no end point to the tolerance of a number of other substances. And, JUDI A. ROBERTS REPORTING SERVICE
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41 1 These are some of the issues in which I believe that what you refer to as nicotine dependence, though I 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 believe would preferentially be referred to as tobacco dependence. Q. Well, nicotine is a substance that causes the dependence, correct; we don't disagree about that? A. I think it's more complicated than that. I think that there's conflicting evidence that nicotine is the only element within the total experience of smoking that produces dependence. So, for instance, if you supplied nicotine to individuals in a nicotine patch or nicotine gum, you find that some individuals will be assisted in quitting with that and other individuals are not. Q. Would you look at paragraph seven of your affidavit, please. A. (witness complying) I'm sorry, paragraph seven? Q. Yes, on page 4. You use the term "nicotine dependence,, in your affidavit, right? A. Yes, I do. Q. Now, let's go back to these distinctions that you were explaining. You want to go through each one and tell me how nicotine on the one hand is JUDI A. ROBERTS REPORTING SERVICE
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52 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 find" when you're talking about nicotine gum nicotine patches. were you talking about an and experience that you personally had or were you just using this in the more general sense about your colleagues and people who are involved in actual treatment programs? A. I was using it primarily in the general sense, but I have had some experience with people who have used nicotine patches sometimes successfully and sometimes not, and nicotine gum. Q. Have you ever worked for another organization that had a program to address tobacco or cigarette or nicotine dependence? A. I can't say that for sure. I've worked for a number of hospitals in my life. Q. You're not aware of any; you can't say under oath that you've worked for any such organization? A. That's correct. Q• How many of your own patients can you testify here today you've treated for cigarette, tobacco, nicotine dependency? A. Early, early in my career I treated a significant number of individuals, perhaps twenty-five or thirty, with hypnosis for smoking. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 49 One significant difference is that everyone who abstains from drugs, such as alcohol and heroin, experience withdrawal symptoms. The nature of the withdrawal symptoms that people experience from withdrawing from heroin, alcohol and barbiturates, et cetera, in terms of their phenomenonology are different and much, much more severe. In fact, those withdrawal symptoms are often life-threatening. The individual withdrawing from alcohol has major autonomic nervous system changes, cardiovascular changes, and may.develop a syndrome known as delirium tremens, which untreated, properly treated, or if properly treated in some instances leads to death. Likewise, withdrawal from heroin, while not often leading to death, leads to a profound experience of sickness which simply doesn't compare to the experience which most smokers report. Furthermore, if you look at the role of withdrawal in the decision of individuals to relapse from their period of abstinence, you find that almost universally people who are in profound withdrawal experiences from drugs, such as heroin or alcohol, cite that experience as a compelling reason JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 50 for their resumption of the use of a substance. You don't necessarily find that with smokers. You find it in many cases, but you don't universally find it; in a significant number of cases you don't find it. For instance, in one study the tobacco abstinence hot line fifty percent of individuals who were calling the hot line out of fear they were about to relapse and smoke again, fifty percent did not report or denied the presence of withdrawal symptoms as a reason for their fear in relapse at' that time. So withdrawal is a very, very different phenomenon in tobacco dependence. I guess this might be a good time to address another issue which you have raised that deals with withdrawal around the issue of the use of the term nicotine versus tobacco dependence. In other dependencies the actual substance which produces the effect of dependency, we believe, is very clear. One can refine heroin. And heroin, in all of its forms, or I should say opiates, in all of their forms, have very, very similar constellations. And regardless of the drug that the person was using, one can substitute another preparation that contains an opiate and receive significant relief from the withdrawal JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 57 MR. LAROCCA: Why don't we take a short break. (Recess taken at 11:52 A.M.) (Deposition resumed at 12:10 P.M. MR. LAROCCA: Back on the record. ) Q. (By Mr. Larocca) Doctor Schwartz, I'm looking at the position description for your position at the Institute of Living; it's dated May 2nd, 1994. And as I read this, is it fair to describe it as an administrative position; in other words, you're in charge overall of the Institute of Living but you don't actually treat patients yourself? A. I think the fairest description is that it is an administrative clinical position irr that I'm responsible for supervising the care of all of the patients who are at the Institute. I'm not required as part of that job description to treat patients myself. Q. Now, I'd like to go back to the distinctions between nicotine or tobacco dependence on the one hand and the other classes of drugs. Now, in terms of the distinctions, I believe you've discussed your view of tolerance and withdrawal, and the third distinction that I wrote JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 40 speak of dependency in relation to any substance. Q. What I'm trying to get at is your -- this is a sort of compare and contrast question; how you compare nicotine dependency on the one hand with these other five drugs, categories of drugs on the other: opiates, alcohol, cocaine, stimulants and barbiturates. A. Yes, I thought that's what I was answering. Q. Fine. A. So there are various criteria. What I'm saying is, there are various criteria by which we compare the drugs that are in the other classes with the effect of nicotine when thinking about the issue of dependence. One would be the issue of tolerance; another would be the issue of withdrawal; certainly, the issues of notion of activities that are engaged in to acquire the drug and to use it is another; the sense of urging. Again, I'm just listing the criteria which I'll discuss when I finish. Q. Certainly, please. A. Urges; sometimes called craving; a term that's difficult to get a real consistent meaning for. And the issue of abstinence; abstinence, quitting; how people quit, success rates, et cetera. I JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 46 take a single dose first. So it is impossible to look at the pattern of the use of a drug without looking at that drug and noticing that substance, it started with a single, smallest dose and wound up with a larger dose at a later point in time. And it is true that people who smoke cigarettes will start with a first cigarette, and that they will often go on to smoke five cigarettes a day, ten cigarettes a day, twenty cigarettes a day or more. But it is most often the case that people who smoke ultimately achieve a particular level of smoking which then remains relatively constant. It's my impression that that is throughout the literature, the Surgeon General's Report, whatever that level might be, five cigarettes, a pack and a half a day, whatever it is,, and that level generally remains stable until an individual successfully quits smoking or cuts down. It may go from an attempt to quit or cut down back up to that level and stay stable at that level, unlike a number of other drugs. Let's use alcohol, for instance, in which an individual begins to drink, and may at some point establish a very significant pattern of alcohol abuse. For instance, a matter of drinking five or six drinks per day, which would usually qualify for JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 60 dependence and other kinds of dependencies, is the psychoactive experience which an individual may experience when using the substance. So that people who use other drugs become frankly intoxicated. I mean, it is commonly known; it's not a matter of science; lay people know it; virtually everyone in our society. knows it: you drink; you get high. You use heroin, and you are, in the lay parlance, you become stoned. You use cocaine, and likewise, become extremely intoxicated in a way that processes of consciousness, thinking, mood, are extremely distorted; impact on the nervous system is very different. Nobody would think that somebody who's used a substantial amount of heroin and cocaine or alcohol ought to drive a car, because we know that the intoxication secondary to these substances is significantly impairing, and fine motor activity, coordination and other nervous system functions. Nobody would say that somebody who is smoking a pack a day shouldn't drive a car because, whatever psychoactive action the tobacco may have, is obviously in a very significantly different category. So when you use these other drugs in the course of the day, if you're dependent upon them, JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 62 Q. Okay. The next, the fourth factor I have is the sense of urgency and craving as one of your grounds for distinction. A. Since I've said from the beginning, that this is not an inclusive list, so I think that the subject of psychoactive effect and intoxication, which I just included in my discussion of activities to require to use it, would stand as a separate item, so I'd like -- if you're going to number these, let's give it a number. Q. Which number? Just help me out. A. I don't care which one. Q. How many different distinctions do you think you've gone through thus far? A. We talked about significant distress, disability, tolerance, withdrawal, activities to acquire and use and intoxication, that's five. Q. So you think we're up to a sixth distinction when we talk about the sense of urgency and craving? A. Yes. Q. Okay. why don't you tell me about your view of that. A. Again, the distinction between the impact of urges to use a substance and craving for it with JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 51 symptoms. So, for instance, you can give somebody who has been treated for pain with morphine and who may have developed a dependency to morphine, another form of an opiate medication, and have the same effect and relief of symptoms of withdrawal. Likewise, with alcohol; you take somebody who has developed a dependency which focuses on vodka and entering an early stage of withdrawal, and you can give them scotch and they might not like it; they might not prefer the taste; but the alcohol in the scotch will relieve the symptoms of withdrawal. Now, with tobacco smoke; an individual who has been smoking goes into withdrawal; we may apply a nicotine patch or nicotine gum, and we find that in many instances that nicotine substitute may relieve the symptoms that we're talking about, but in a significant number of instances it does not. And, so again, you take the substances that are supposed to be tobacco, the psychoactive substances, and it's more complicated than to be able to say that psychoactive substances produce a dependency. These are some of the ways that withdrawal is different for tobacco as opposed to other drugs. Q. Doctor Schwartz, you use the phrase "we JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 61 and you're using them frequently, your life is devoted to periods of intoxication, which prevent normal, productive functioning aspects of your life. Periods of recovery from that period of intoxication, which might include withdrawal experiences, but, at the very least, even in the absence of very significant withdrawal experiences, usually require a significant period of recovery. With illegal substances, then cycle in which effort and energy goes into the purchase of an illegal substance, often requiring criminal activity, not only in the purchase itself, but also acquiring the vast amount of money to purchase the the substance when you're dependent. And so your life comes to revolve around the use of the drug to which one is dependent in ways that are very different from the impact of the use of tobacco in the life of a smoker. So individuals who are dependent upon tobacco by and large remain able to work, to engage in family life, to maintain good relationships with their spouses and their children. And individuals who are significantly dependent upon other substances by and large are impaired in all of those kinds of functions. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 55 psychiatrist who practices hynosis for, so it wasn't a specific program within my practice to treat only individuals who smoke. Q. But that was the indication or the problem for which they wanted to be hynotized? A. For these particular patients, yes. Q. What happened to the twenty-five or thirty, did you get any of them to stop smoking? A. I really can't report long term follow-up because I did not have long term contact with most of those patients. My impression of short term follow-up, meaning days to weeks to even months, was that roughly one-fourth to one-third of the people who were so treated stopped smoking. Q. You never published the results of those anywhere? A. No, this wasn't research; this was a practice. Q. While we're on the subject; I don't see in any of your publications in your C.V. anything related to nicotine dependence, tobacco dependence or smoking cessation; is that correct? A. That's correct. Q. So you never published any article of any type on any of those subjects? JUDI A. ROBERTS REPORTING SERVICE
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53 1 Since that time, over the last few years, I, myself, 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 have not treated a significant number of people, but I've had patients who"were being treated by their internists or their generalists and have discussed- issues of smoking with them and the success in their attempts to stop and the use of these nicotine substitutes. Q. If we go to your resume, Doctor, Exhibit 2, the curriculum vitae, that is the end of it; which of the time periods and which organizations were you referring to with respect to the hypnosis? A. It was primarily when I was a resident at the Payne Whitney Clinic, New York Hospital and then for the beginning of the period when I was at Beth Israel Medical Center. Q. Where are we; we're on page A. well, my time as a resident would be under -- on the face page it has my name on the top under "Education and Training", internship and psychiatric residency at New York Hospital, Cornell Medical Center 1979 to 1983. Actually, let me correct that answer. After that year I spent one year doing a fellowship. And while I was doing a fellowship I was also in a part-time private practice, and in that part-time JUDI A. ROBERTS REPORTING SERVICE.
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 64 who have quit smoking. That's twenty-five percent of the,adult population. There may be another forty-eight million adults, according to one set of figures, who currently smoke; that's another twenty-five percent of the population. Of the forty-five million people who are former smokers, ninety percent have quit smoking on their own without the assistance of any kind of treatment program. That is a fact that stands in great distinction to what are known to be spontaneous quit or abstention rates for other substances. I have seen no estimation of spontaneous quit rates for any other substance that is above thirty percent. So obviously there's something very, very different in the experience of smoking and what has sometimes been called the compulsion to smoke as the experience of using other substances where the compulsion is to use other substances. And that difference, I think, if a difference of the term of dependency means anything, it ought to mean how easily individuals are able to stop the behavior of substance use. Again, in terms of quitting behaviors; if you look at what are the factors that go into successful quitting for a variety of substances, you JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 56 A. My expertise and interest in this issue again has to do with issues of patient motivation, compliance with medication and other health advice, refusal of health and treatment advice, which are issues that I have published on. Q. But just so we're clear. You haven't published any article on this subject of nicotine addiction or dependence or tobacco addiction or dependence or cigarette addiction or dependence; is that correct? A. That's correct. Q. And the same question would be true if I asked you about nicotine cessation, tobacco cessation or cigarette cessation, correct? A. Correct. Q. And is the same true, if we look at your presentations which are on pages -- A. The same is true. Q. -- four through -- just so we're clear -- four through eight of your resume; you've never made a professional presentation on any of those subjects: nicotine dependence, cigarette dependence, tobacco dependence, nicotine cessation, tobacco cessation, cigarette cessation, correct? A. Correct. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 63 regard to smoking as compared to other substances is important. Let's use heroin. People describe a craving for heroin, which is a significant component in their choosing to use it at any particular point in time. If you supply the individual with a substitute opiate, the sense of craving or the urge to use is satisfied. An individual who smokes may report an urge to smoke and craving. If you supply the psychoactive substance, supposedly this psychoactive substance, nicotine, that urge or craving may or may not be substantially modified by the provision of a nicotine substitute. Q. okay. And the next factor I have, I guess, would be the seventh factor, and that would be abstinence and quitting. And in your view, how is that different for nicotine dependence on the one hand and all the other drugs? A. I think if you look at how people quit, the patterns of quitting and issues involved in quitting and success rates in quitting is extremely different between these substance dependencies. There are, depending on which set of figures may be the most current, anywhere from forty-five to forty-eight million American adults JUDI A. ROBERTS REPORTING SERVICE
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58 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 down were, how-you acquired the drug, or did you cover that also? A. No, I haven't covered that yet, but I think it's almost a subsection of my coverage of withdrawal. I also covered the effect of resupplying the substance to an individual who is undergoing withdrawal in which that is significantly different. Q. And which of those; which of the five is that then? A. That's a part of withdrawal. Q. Okay. So why don't you talk about the third distinction that you see, which I have written down as how you acquire the drug. A. Yes. Well, and I think I had a slightly expanded way of saying that, which is how you acquire it and how you use it. The activities involved in acquiring a variety of substances differ significantly, and they have some differences on the basis of whether the substance is legal or not. The activity of drinking obviously involves the purchase of alcohol. Smoking involves the purchase of tobacco. Other substances involve illegal activities in terms of the acquistion of the Ln N J J m JUDI A. ROBERTS REPORTING SERVICE.
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65 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 find that motivation, commitment to quit has been demonstrated. That individuals who are committed to total abstinence at the.time they make a quit attempt, as opposed to individuals who are saying that they want to quit but perhaps are ambivalent as to whether total abstinence is necessary, that those individuals who have the commitment up front to total abstinence are individuals who by and large are more successful at quitting, who quit with a much higher quit rate. Going back to the numbers. With regard to the numbers of smokers who quit on their own; there are studies which take a look at what quit attempts, what people are really intending or are really ready for when they make a quit attempt. And these studies indicate that though large numbers of people say that they want to stop smoking, really only about twenty percent of people who smoke at any particular time are actually committed to making an attempt to stop smoking within, say, the next few months. Now, if, in fact, only twenty percent of the people who smoke may actually be committed seriously, and you go beyond simplistic questions like, would you like to stop smoking, to investigate JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 59 drug. But whether the activity is legal or whether it is illegal, the general view of addiction, I will put that in quotes, and my preferred term of dependency, that individuals spend very, very significant amounts of their time and energy to acquire and use the substance. A prototypical example are individuals with heroin addiction who -- shall I wait? Q. No, go ahead, please. A. Individuals with heroine addiction. Q. Excuse me for a minute, Doctor. Go ahead. I'm sorry to interrupt you. A. The best examples are individuals with heroin addiction who spend significant amounts of their time and energy to acquire heroin, and in order to do so, have to substantially engage in activities that come to define their lives, so engage in criminal activities and tend to slide down a social scale such that their lives are focused around the use of the substance and the consequences with regard to the use of the substance. Now, one of the consequences of the use of the substance, and it could stand as really still another category in terms of the criteria for a dependence which are different between tobacco JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 70 A. Probably; I can't say for sure. Q. Okay. And we have another shade of purple called "Substance Abuse"; can you recognize this brochure? A. That again is part of a series produced by the American Psychiatric Association. Q. It's given out at the Institute of Living; if you go into the Institute for Living you can get all these brochures? A. I think that's probably true because we ordered a set, yes. MR. LAROCCA: I'd like to mark this as Schwartz No. 7. (Schwartz Exhibit 7, Copies of brochure, marked for identification) Q. (By Mr. Larocca) By the way, did you order them yourself? A. No. Q. These sets; who ordered them? A. Our Public Information Office. Q. I'm representing to you, Dr. Schwartz, that this is a photocopy of the same purple brochure that I've been showing you that's called "Substance Abuse". A. Okay. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 68 (Schwartz Exhibit 6, Supplement to The American Journal of Psychiatry, marked for identification) Q. (By Mr. Larocca) And just for the record, what we have marked as Schwartz 6 are the treatment guidelines that you just referenced that contain the relapse rateS that you were just testifying about? A. Yes. Q. Now, I think we've finished the distinctions of the -- list of distinctions, as I have them written down; is that correct; in other words, the distinctions between nicotine dependence and the other drug dependencies? A. Just a moment; I'm going over the list. Q. Sure. Take your time. A. (Witness reading document) I think so, yes. Q. So would it be a fair summary of your position, Dr. Schwartz, to say that you do not think that nicotine is an addictive drug comparable heroin or morphine? to A. I think that the term "addictive drug" is absolutely the wrong term to apply to the use of tobacco, and certainly not comparable -- I'm sorry, JUDI A. ROBERTS REPORTING SERVICE.
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71 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. LAROCCA: Why don't we, just for the record, we will mark as 7A, the original. (Schwartz Exhibit 7A, Original brochure, marked for identification) Q. (By Mr. Larocca) On its face it says "American Psychiatric Association"; what type of publication is this? A. This is a series of publications that was created by the A.P.A. for distribution to the public. Q. And you're a member of the American Psychiatric Association?. A. I certainly am. Q. And you have been for how long? • A. Since 1983; '83, I believe. Q. Have you ever read this brochure that the Institute for Living gives out? A. No. Q. I'd like you to turn to page 21, please. A. (Witness complying) Q. Do you see in the right-hand side column there in big bold it says "nicotine"? A. Yes. Q. Would you read into the record the first JUDI A. ROBERTS REPORTING SERVICE
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69 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 which drug, heroin? Q. Heroin or morphine. A. Or morphine, yes. Q. Now, is that your own opinion or is that an opinion of any professional group that you can point to? A. I think that the use of the term "addictive drug", and the equations of the drug to heroin and morphine or other significant drugs of abuse, is an issue that is controversial amongst mental health professionals and within the medical profession. Q. Do you have any brochures that you give out at the Institute of Living? A. Yes, we do. Q. Okay. I show you a yellow brochure; it says "Depression"; is that one you can recognize? A. That is a brochure that is created by the the American Psychiatric Association. Q. But it's distributed at the Institute of Living, isn't it? A. Yes, correct. Q. Another one in purple that says "Mental Illness and Over-view"; is that available at the Institute of Living? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 72 full paragraph, please. A. "After years of controversy over the damages of smoking the'latest report by the United States Surgeon General has confirmed that nicotine and tobacco products is an addictive drug comparable to heroin or morphine." Q. You disagree with that statement, correct? A. Yes. Q. would you read through to yourself the remainder of that page and the following page all the way to the end of the nicotine section and then I'd like to ask you, are there any other statements in that section on nicotine with which you disagree? A. (witness reading document) I've finished reading it. Q. Okay. MR. NIMS: Before you answer. I object to the extent that the question is intended to ask about things in this that are outside his expertise or outside the issue on which we're conducting discovery, which is the class certification question. MR. LAROCCA: Sure. ~ ~ V V m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 54 private practice I treated a few patients; I can't tell you how many; with hypnosis for smoking. Probably about the time I arrived at Beth Israel Medical Center in 1984 I was no longer engaged in that activity. Q. So it's principally during the years -- when did it start, as early as '79? A. I can't say for sure. Q. It was during the time period '79 through '83? A. Through '84. Q. You treated approximately twenty-five or twenty-five to thirty patients? A. That would be my guess. Q. What type of program was this; you say it was a hypnosis program; who sponsored it? A. It wasn't a program; it was my own personal treatment. Q. I see. You hypnotized patients? A. Yes. Q. And you hypnotized them because they told you they wanted to stop smoking? A. Well, actually I was practicing hypnosis for a variety of problems, but that's one of the kinds of problems that people sometimes come to a JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 67 is that about thirty-three percent of people who are committed to quit are abstinent over a period of days to weeks, and three to five percent of people who in any individual quit attempt are abstinent at the end of one year. Q. what document are you referring to? A. It is a document which I have given to you; it's the "American Psychiatric Association's Treatment Guidelines for Nicotine Dependence," or, I believe that's the title. Q. Could you find it for us? MR. LAROCCA: Off the record. (Discussion off the record) MR. LAROCCA: Back on the record. THE WITNESS: The cover is green, dark green. MR. LAROCCA: Do you mind if we mark this as an exhibit? THE WITNESS: I don't mind so long as I can have it back at the end of this day. MR. LAROCCA: We can make a copy before we leave today. Will that be all right? THE WITNESS: Sure. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 73 Q. (By Mr. Larocca) Go ahead, Dr. Schwartz. A. To answer your question, I need to go paragraph by paragraph through this. Q. Please. A. Okay. Getting back to the first paragraph. This says that the U. S. Surgeon General has confirmed that nicotine and tobacco products are addictive drugs comparable to heroin and morphine. It is true that the United States Surgeon General has said that. I feel that the statement is a -- strike that out. Let me start that response again. A better statement would be that nicotine and tobacco products produce dependency. I believe that the use of the term "addiction" by the U. S. Surgeon General and others is an unfortunate term. Q• Okay. Paragraph two. And, by the way, I don't want -- I want to take the objection of your counsel seriously. If you think that there are paragraphs you just don't have any enough information or expertise about to have an opinion, please say that also. In other words, I don't want silence to be acquiescence. A., Sure. That is how I feel about paragraph 2 5 11 two. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 75 A. In paragraph four, I think it is worthy to note that the issue of discussion of nicotine is kind of confused by the use of the term "habit" in that*there seems to be an acknowledgment there's a habit forming habituating component to the behavior at the same time the term "addiction" has been used. In the next sentence; most people try repeatedly to try to give up smoking without success. I guess I have to differ with that conclusion. Most people who try to give up smoking; did you look at any particular quit attempt, a large majority of people fail in any particular quit attempt. The truth remains that a huge, forty-eight million, a huge number, forty-eight million people have successfully quit smoking. There are about forty-eight million other smokers who are at various stages; many of them in the process of quitting; some are not at the stage of any process of quitting, and I don't think it's possible to come to the conclusion that most people try to give up smoking without success. Q. Doctor, how is it -- I'm a little puzzled, how is it you know precisely numbers, the forty-eight million have tried to quit and so forth, but you have no idea about how many deaths a year JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 66 at a deeper level what a person means, and you discover many people who say they'd like to, twenty percent who might be committed, and then you look at the success rate of about five percent of people who spontaneously quit succeeding, you have a rate of success at spontaneous abstention that is even higher. It stands in distinction to spontaneous quit rates in other substances which are generally believed, not universally believed, but generally believed within the various mental use and abuse profession, to require treatment programs to bring people to a condition of abstinence. Q. Do you know what the relapse rate is for cigarette smokers? A. Well, are we talking about the relapse rate from first quit attempt or second or fourth or fifth or seventh, because they are quite different? Q. Just overall relapse rates within the first year. A. They are very high. Q. Do you know about what percentage? A. According to the "American Psychiatric Association's Guidelines Treatment of Nicotine Dependence",, as that particular document is called, I believe the number, and I can't be quoted exactly, JUDI A. ROBERTS REPORTING SERVICE
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76 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 are attributed to tobacco? A. My area of expertise of both within a special interest in psychiatry. As that special interest applies here, has been and always has been around issues of compliance with medication regimens, the decision making process, motivations to either adhere to or to refuse doctors' suggestions, et cetera. And I have looked at the issue of how many people smoke and how many people quit as part of that larger issue. My area of expertise has not been in this other area. And I haven't -- Lord knows there's enough to read in this life; I have only been able to pay attention to a subject that I am addressing. Q. So just going back to this. But whEn it says that 320,000 deaths a year in this country are a result of tobacco products, are you saying you never read anything at all about the mortality rates linked to tobacco or you've read it and just haven't retained it? A. Oh, I'm sure that I've read about the mortality rates that I know are related to tobacco use, or that are felt to result from the risk which tobacco smoking creates, but that's not a number ' that I would use. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 74 Q. You just don't know one way or the other? A. That's correct. Q. You don't have any basis to disagree with it, but you don't know enough to say that you agree; is that fair? A. That's true. Q. But it does say -- I'm sorry, the last sentence says, quote, "320,000 deaths a year in this country are the result tobacco products." End quote. Now, you have read statistics, I take it, about deaths attributed to the use of tobacco, right? A. I don't remember what those statistics are. Likewise, in paragraph three, while I know that it is true that smoking remains higher for black smokers than for whites, I don't know the percentage; I neither agree or disagree. Q. Fair enough. A. In paragraph four -- by the way, is there a copy I can keep? Q. Sure, that's the original. I'11 give you another. MR. NIMS: That's the exhibit. Let me give you this one. JUDI A. ROBERTS REPORTING SERVICE
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79 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 starts a new paragraph, I realize. A. Actually, I think I have to get back to that last comment you made, that the confusion might be particularly within the American Psychiatric Association. I think that the American Psychiatric Association has made a very serious attempt to address the issues which you're asking about today. And, in fact, in their own publications there is confusion. It reflects, I believe, the degree to which in many instances political concepts and political issues and matter of public policy have intruded into the debate about tobacco dependence to obscure what are more of the scientific issues, such as definition of dependence in an attempt to have an impact on public policy, public perceptions and public behavior, for instance, by substituting concepts of addiction for concepts of dependency. So I think that the confusion has been engendered in part by the Attorney General. It has been engendered in part by lawsuits against tobacco companies which attempt to equate issues of dependence with these matters of addiction which imply that individuals have lost control of their behavior and lost control of their lives and are no JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 81 (Schwartz Exhibit 8, Report of The Surgeon General Report 1988, marked for identification) Q. (By Mr. Larocca) You have produced a copy of the full 1988 Surgeon General's Report today; I take it that that is your own personal copy? A. Yes. Q. When did you first obtain that document, Dr. Schwartz? A. I don't remember. Q. Was it around the time it was published in 1988? A. It may have been a little bit after; '89, '90; I really can't say; I've lost track. Q. Now, what is your understanding of the process that the Surgeon General's Report reports in general, and this one in particular, went through in terms of peer review? A. My understanding is that the Surgeon General assembled a collection of individuals that he considered to be authoratative in this field. I believe he assembled a collection of individuals that he considered to be authoratative and who also shared his point of view with regard to public JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 80 longer personally responsible for the decision to engage in activities such as smoking. In the kind of atmosphere in which we, as a nation, through these lawsuits and other issues, are attempting to establish that people don't have responsibility because they have used the substance, which, by virtue,of their repeated use and failure to quit, almost by definition means that they are then, quote, "addicted", end quote, which means by definition, then the definition is used in these suits, that are unable to conform their behavior; that's, I think, a source of confusion. Q. Let me, Doctor, move on. I'm afraid our time is going to be too short, so I'm going to come back to the remaining paragraph of that. A. I'd really like to talk about the remaining paragraph. I hope we get back to it. Are you sure we can't do it now? Q. Well, let's save it because I have so much to cover with so many of the other documents you've produced. MR. LAROCCA: Let's mark as the next exhibit, Exhibit 8; this is a chapter from the Surgeon General's Report 1988 entitled "Nicotine Addiction". JUDI A. ROBERTS REPORTING SERVICE
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84 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the entire 600 page Report? A. Well, I mean, it is under a heading entitled "Major Conclusions", so -- Q. Do you understand this to be a summary of the findings of the entire Report? A. I have to look at the entire Report a little more closely. That is likely to be the case, yes. Q. Would you read the first of the major conclusions? A. "Cigarettes and other form of tobacco are addicting." Q. Do you agree or disagree? A. I disagree with that conclusion. Q. And would you read into the record the second major conclusion, please. A. "Nicotine is the drug in tobacco that causes addiction.° Q. Do you agree or disagree? A. I cannot so simply answer that question in a"yes° or °no" kind of agree or not agree format. I believe that nicotine is a drug, chemical substance in tobacco that produces dependence. There are factors involved in the use of tobacco that compounds the issue of dependence. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 89 A. I would have to recapture in my thinking the amount of time that this took. Perhaps $7,000; that's a guess. . Q. - Had you done any memoranda that you had transmitted to Jones, Day prior to this time, September of 1995? A. No. Q. But you had been consulting for Jones, Day since 1986, correct? A. Eighty-six or '87. Q. Does that mean everything that you'd done for Jones, Day up to that time was oral? A. I'm not sure. What do you mean, oral? Q. You had never transmitted any pieces of paper to Jones, Day prior to September of 1995? A. I believe that's correct. Q. So all the transmissions were oral conversations? A. Yeah. Q. Had you received anything from Jones, Day from the period 1986 up through the present? A. Yes. Q. Can you describe those? A. At various times, as Jones, Day was involved in different cases of litigation against R. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 87 literature, various articles on compliance or noncompliance with medication, with medication regimens or with general health recommendations on various psychological issues, such as the concept of self-efficacy, health, locus of control, an attribution theory, which are psychological theories which have bearing on how individuals take responsibility for responding to recommendations and change in behaviors. And the subject of motivation, social supports and motivation and social supports all impact decisions to quit smoking. One memorandum I see is on the issue of why smokers ignore warnings bearing on how people hear, perceive, reason about and respond to information that their health, the relationship of physiological and psychological factors and withdrawal factors that discriminate quitters from noquitters, and distinguish motivation and committment and the requirement for psychological readiness to be able to act on doctors' orders. These are all memorandums that I prepared during this period in November -- in September of '95. Q. And who did you prepare them for? A. Primarily for myself. I was reading literature on these issues and felt that it would JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 78 finished; that's at the bottom of page 21? A. Give me another second. Q. Oh, sure. A. Well, actually, what's of interest here is the relapse rate at the end of first year is lower than the relapse rate that I had referenced earlier which I had referenced from another American Psychiatric Association publication. So, obviously, even within the American Psychiatric Association there's a fair amount of confusion and difference opinion on the part of various people within that organization about many of these issues. Q. You say even within, maybe it's especially within? of A. Well, I wouldn't know if it's especially within or how far afield confusion about these issues actually extend. It is my impression that the kind of confusion about terminology and figures that we're talking about is a confusion that is part of a national malaise with regard to our views about the role of dependency and, quote, "addiction", end quote in society, and, in particular, about what, tobacco smoking. Q. Let's turn to the top of 22 which is JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 91 York case where you submitted an affidavit. We talked about some depositions there, so those we know about already. A. You're asking me if I can remember the names of depositions or cases? Q. Either. A. Usually there's a single name that comes to me the name of the case. Q. Okay. A. Rossi one; Fahey was another; there was one that starts with a C; Costanso (phonetic); those are the names that come to mind. I believe there were another one or two. Q. were you involved in Florida cases Engle or Broyne (phonetic); do those names ring a bell? A. I believe that I read something in relation to Engle. Q. Have the depositions been principally depositions of plaintiffs as opposed to other experts? A. They have been principally depositions of plaintiffs, and a couple of cases I've read the depositions of experts also. MR. LAROCCA: Doctor, I'd like to mark as the next, Exhibit 10; it's a Ln ~ -j J m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 93 quote, "Nicotine dependence, as assessed by the Fagerstrom tolerance questionnaire, (F.T.Q. 1978), was predictive. However, this suggests that the F.T.Q. can be a useful tool for measuring addiction to nicotine." Do you recall when you highlighted that and why? A. I can only say I highlighted it somewhere during that period in September. Q. September of '95? A. September of '95 when I was reading these articles. Q. So they relate to the memos we marked as Schwartz No. 9? A. Correct. Q. And next to it in the marginal notes it says "check this"? A. Right. Q. And there's an arrow drawn over that; is that your writing? A. Yes, it is. Q. And did you -- and the "check this" refers to the sentence about the Fagerstrom test being predictive? A. Yes. JUDI A. ROBERTS REPORTING SERVICE
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1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 92 one-page piece; it's called the "Fagerstrom Test for Nicotine Dependencew. (Schwartz Exhibit 10, Fagerstrom Test for Nicotine Dependence, marked for identification) Q. (By Mr. Larocca) Can you identify this? A. This is a test which has been used in a number of studies to attempt to give a score to the degree to which an individual may be dependent upon tobacco. Q. Let me show you an article that you produced to us today. A. Yes. Q. I'm not going to mark it. It's entitled "Longitudinal Analysis of Predictors of Quitting Smoking Among Participants in a Self-Help Intervention Trial" by Holly A. Hill, et al., and it's from Addictive Behaviors Volume 19, No. 2, 1994. And I'd like to first ask you: are these your -- did you make the yellow highlights that appear on this? A. Yes. Q. Page 164 the following appears in a portion that you highlighted in yellow; it says, JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 82 policy and political implications as to how the matter would be handled. But many of' the issues within that report are basic science research issues and procedures of peer review are analogous to other peer review procedures in which a variety of individuals who are active researchers in the field who review the work of others. Q. Let me ask you to take a look at page 5 of this exhibit. A. (Witness complying) Q. In the second full paragraph, do you see the reference that says that this Report reflects the contributions of more than fifty scientists representing a wide variety of relevant disciplines. And skipping down to the middle of the chapter it says, quote, "These draft chapters were subjected to an extensive outside peer review (see Ackowledgments of individuals and their affiliations) whereby each chapter was reviewed by up to eleven experts. Based on the comments of these reviewers, the chapters were revised and the entire volume was assembled. This revised edition of the Report was resubjected to review by twenty distinguished scientists inside and outside the JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 83 Federal Government, both in this country and abroad. Parallel to this review, the entire Report was also submitted to twelve institutes and agencies within the U.S. Public Health Service. The comments from the senior scientific reviewers and the agencies were used to prepare the final volume of this Report." When you -- strike that. Do you have any reason to disagree with that statement of how this Surgeon General's Report was put together? A. No. Q. Would you turn to page -- by the way, the front piece of the Report, the title of the Report says "Nicotine Addiction", and I gather from your testimony you disagree with that title; you think it's a -- go ahead. A. I feel it is an unfortunate choice of words and that it would be more appropriate to use the word "nicotine dependence". Q. And if you would turn to page 9. A. (witness complying) Q. Do you see in big bold, about the thirds of the way through, it says, "A summary of the main findings of the Report follows." And these are -- do you understand these to be the main findings of JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 85 Q. would you read into the record the third of the major conclusions, please. A. "The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.'' Q. Do you agree or disagree with that major conclusion? A. Again, I can neither agree nor disagree with that further stipulation. I believe that there are similarities in the pharmacologic and behavioral processes that determine tobacco dependency, and there are also very, very significant differences that determine dependency to drugs such as heroin and cocaine. Again, going back to No. 1. I should probably clarify my objection to No. 1 is the statement as upon modified. I believe that there is evidence that cigarettes and other forms of tobacco produce a kind of dependency. MR. LAROCCA: I believe this would be a good place for a lunch break. You have something else to say, please, go ahead. A. With regard to my objection to conclusion JUDI A. ROBERTS REPORTING SERVICE
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95 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 locus of control and attribution in which people posit the locus of control, the center of control within themselves as opposed to out there, for instance within substances or objects are also predictive. But primarily what's important, I think, are the studies that look at the notion of motivation and commitment to abstinence at the time of quitting. This is not to say that some of the elements or all of the Fagerstrom questionnaire does not predict some component of what we're calling "dependence". But it's only one element, and it's certainly not determinative to the degree of dependence. And there are individuals who score highly on the Fagerstrom questionnaire who are able to quit much more easily than some individuals who have lower scores. Q. Now, did that last answer about the limitation of the Fagerstrom questionnaire, was that Harold Schwartz's personal view or were you purporting to reflect the assessment that is reflected in the literature; in other words, is there anything you can point to that says the Fagerstrom index only predicts a component and is not a good predictor? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 96 A. I didn't say that the Fagerstrom questionnaire was not a good predictor. I said it was a predictor, but that there were other elements which, if you do a kind of statistical analysis and look at which factors are best, there are in some studies indications that other factors, the kind of factors that I have just related that are more powerful predictors than the Fagerstrom questionnaire. Q. Would you agree with me that the current view of the American Psychiatric Association is that the Fagerstrom index is a good predictor of nicotine dependence? MR. NIMS: Read that back, please. (Whereupon, the question, "WOuld you agree with me that the current view of the American Psychiatric Association is that the Fagerstrom index is a good predictor of nicotine dependence?" was read by the reporter) MR. NIMS: You can answer it, but I'm not sure I know what you mean by "the view of the American Psychiatric Association". I'm not sure whether the Association has a view. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A. 94 Did you check that statement? Well, what I meant by "check this" was, look into the Fagerstrom_tolerance questionnaire, which I did. And at the time that I read this I had not actually seen the questionnaire itself. And I also found other references to the Fagerstrom questionnaire which put this statement her.e into perspective, so that it's one thing to say that this questionnaire is predictive of dependence or the capacity to quit, but it has to be put into perspective with regard to what other things might be predictive and what other things might even be more powerfully predictive. So there are some studies, some of which I believe you have, they're in the articles that I gave you that indicate while the Fagerstrom questionnaire might be predictive, that there are issues such as personal motivation, commitment to quit, factors, such as the belief in self-efficacy. Self-efficacy is a psychological.theory, but it explains the degree to which people believe that they have the capacity to take actions themselves and-to control their own destinies. Scores on self-efficacy tests are as predictive or more predictive. And, likewise, the concept of health, JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 97 MR. LAROCCA: That's fair enough. You can answer it. A. I think that, to my knowledge, the most rece. nt statement by anybody within the American Psychiatric association about the Fagerstrom questionnaire is in this exhibit. May I see that for a moment, please? Q. (By Mr. Larocca) Yes. Exhibit 6, the October, 1996 supplement? A. Yeah. Q. Sure. What is the view in this publication? A. I think that we ought to read what it says in order to establish with clarity what it is. I think it is a mixed statement. Q. Let me direct your attention to page 6, right-hand column, two-thirds the way down. Why don't you read that paragraph into the record. First of all, that's highlighted in the original, correct; it's highlighted in yellow marking? A. Yes. Q. You made that highlighting? A. Correct. Q. You made all the yellow markings JUDI A. ROBERTS REPORTING SERVICE
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88 1 help me to digest the material by engaging in the 2 exercise of abstracting the articles in memorandums. 3 Secondarily, I sent a copy of the work I 4 was doing to Mr. Nims. 5 Q. Mr. Nims is the attorney sitting next to 6 you? 7 A. Yes. 8 Q. From the Jones law firm? 9 A. Yes. 10 Q. I want to understand your testimony. was 11 this in response to a request from Jones, Day or not 12 est f o Jo es Da ? i t , y n response o a requ r m n 13 A. It was my suggestion that I do this. I 14 felt that it would help me to retain and reason 15 through the issues that I was reading about. 16 Q. So you proposed this project to Jones, 17 Day? 18 A. Correct. 19 Q. They said, okay, and you went ahead and 20 did it? 21 A. Yes. 22 Q• How much were your bills for generating 23 this memorandum? 24 A. I don't know off-hand. ~ 25 11 Q• Give us the magnitude. ~ ~ _J m m ~ m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 86 No. 1; going back to that. In which I believe that cigarettes and other forms of tobacco produce a type of dependency, I would like to add that, though they do, the nature of that dependency, as I have explained earlier in this deposition, is significantly different than the nature of the dependency to other substances. MR. LAROCCA: Off the record. (Luncheon recess taken at 1:05 P.M.) (Deposition resumed at 1:51 P.M.) MR. LAROCCA: Back on the record: I'd like to mark as the next exhibit a set of documents; there are a series of memoranda written by Dr. Schwartz, and they have different dates on them,. and they have at the top one through thirteen, and we will mark this; we will mark them 9A through whatever letter. (Schwartz Exhibit 9A through M, Memorandum, marked for identification) Q. (By Mr. Larocca) Doctor Schwartz, can you identify these memoranda for us? . A. Yes. These are memoranda that I prepared in September of 1995 with regard to issues of how patients make decisions from the informed concept JUDI A. ROBERTS REPORTING SERVICE
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98 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 throughout this document? A. Yes. Q. If possible, when it's copied, we'd like to have it copied in a way that the highlights are shown. I don't know if that's doable. A. I'll try my best. The highlighted portion reads: "The Fagerstrom scale assessments (table 3), widely used in treatment studies, have proven reliability and validity. They have been shown to predict success at stopping smoking and, more importantly, to predict which smokers especially benefit from nicotine gum or nasal spray. (See section III.F.2.e.)." That's in parenthesis. "Several other markers of nicotine dependence have been proposed; e.g., number of cigarettes per day, time to first cigarette, (an item on the Fagerstrom scale), cotinine levels, amount of withdrawal on last attempt, and number of unsuccessful quit attempts. However, with the- possible exception of time to first cigarette, these have yet to be shown to have significant treatment utility.° Q. Thank you. A. I think it's important to note in a section in the back on page 24, the following JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 90 J. Reynolds, I received copies, usually of depositions that had been taken in relation to those particular cases. I was asked to read those depositioas and engage in discussion about my views about them. Q. Can you recall approximately how many depositions over that period? A. It would be easier to recall approximately how many cases than the actual number of depositions. Q. How many cases? A. Roughly four or five, I think, major cases. There were some cases that were not directly R. J. Reynolds/Jones, Day cases. So, for instance, I had at some point read the deposition of Rose Chiapalone (phonetic) and engaged in discussion about it, so that might be in addition in terms of the number of cases. There might be other examples like that. Q. Can you tell me the name of any depositions that you can recall as you sit here today? A. Rossi was one. Q. By the way, you can exclude any depositions you read in our case and also in the New JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 77 Q. You're in paragraph four? A. Which? Q. Which continues onto the top of page 22. A. I guess I need to say something else about this; the sentence that I find objectionable. Q. Sure. We're still on paragraph four? A. No, no, we're on paragraph two, back to the 320,000 deaths. Q. Sure. A. The sentence says, "are the result of tobacco product use." And here again, I think that there is a somewhat loose use of language here. What is known conclusively about tobacco use is that there's a compelling association between smoking tobacco or using tobacco in other forms and the risk of a variety of diseases. This sentence implies that in any particular individual, a particular disease was caused by the use of tobacco. I don't think there's anything in science that justifies that conclusion. It is often said in the lay press, and even in publications that are intended for the lay press, there's a blurring of that distinction; it's, I think, an important distinction. Q. Now, we're in paragraph four; have you JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 101 Q. No, no, this was not produced by you, no. It says "Mayo Foundation Nicotine Dependence Center Patient Questionnaire". if I could show you your affidavit and which I think is Schwartz No. 2, and would you look at paragraph 12, please; it's on page 7. A. (Witness complying) Yes. Q. And let me just read it into the record. It says, °The above discussion illustrates the need for more information than provided by the proposed class definition. It is necessary to know more than that a person is a current smoker, resident in Pennsylvania who began smoking before age nineteen if one wants to assess whether he or she is nicotine dependent under any definition of that condition. For example, we need to know whether the individual ever seriously wanted to quit, was motivated to do so, had ever made any significant attempt to do so or has any plan to do so in the future.,' Would you agree with me that the Fagerstrom questionnaire and/or the Mayo questionnaire provide the information that you're talking about in paragraph 12? A. No, I don't think the Fagerstrom questionnaire provides that information, and I JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 103 So, for instance, it's very easy to check off on a questionnaire, I've seriously wanted to quit, and I've made a serious quit attempt which failed; one could check that off in a questionnaire. But you have to sit face to face with a person and interview them to get the details of what it was that they considered to be a serious quit attempt. Low and behold, you find even with some of the plaintiffs in this very case, that what is first reported to be a serious quit attempt, when you ask a follow-up set of questions, turns out not to be so serious. Q want. You have a plaintiff, whose name -- You can look at your affidavit, if you A. Oh, okay. Q. You mentioned two people, Ciaran McNally and Barbara Salzman; they're in paragraphs 9 and 10. A. So, for example, a theoretical individual such as Barbara McNally. Q. She's not theoretical. A. Ciaran McNally, okay, I'm sorry. An individual, okay, let's not make it theoretical. Ciaran McNally could have Q. She'd be very upset to hear you say Ln 1-1 _j -j m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 105 "I smoked right the minute I got out the door", end quote. Now, even she acknowledges that that was not truly a serious quit attempt. Q. Doctor, let me -- the subject that we're talking about is assessing nicotine dependence, right, and that's the issue that we're addressing, that you're addressing in paragraph 12 of your affidavit, and what we've been talking about. And the question I have is: when you describe these incidents of whether Ciaran McNally made a serious attempt or didn't make a serious attempt, or Barbara Salzman made what you would consider a serious attempt or didn't make a serious attempt, how does that relate in your mind to an assessment of whether the person is nicotine dependent or not? Let me ask a follow-up question. As I hear you speaking, you said Ciaran McNally didn't make a real attempt because back. Is it your view that people who are sort of weak-willed and aren't making what you would consider a real effort to quit, are not to be diagnosed as nicotine dependent; it's only sort of somebody else who can be assessed or diagnosed as nicotine dependent? a week later she went JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 104 "theoretical". A. I mean her no disrespect. She could have reported a serious quit_attempt, and that attempt was an attempt to go, to quit cold turkey in approximately five years prior to her deposition. Only upon examination of the details of that attempt do you learn that the attempt lasted only one week, and that irritability was the only discomfort that she remembered. And that looking back on the experience, she couldn't really say for sure that she really wanted to quit at that time, which would reflect the issue of the degree of real commitment to quit in any particular quit attempt. So you can ask questions like, have you ever wanted to quit smoking? And you can get back response. You can ask that question in a gallop pole and call people up on the telephone and have a them fill out questionnaires and have eighty percent of the people say, oh, sure, I'd like to quit. But that's very, very different from the reality of developing the motivation and commitment to make the serious quit attempt. Going back to Ms. McNally. She made another attempt to quit. She went to Smoke Enders and as she was walking out the door, she says, quote JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 106 What I'm trying to get at is the link between this last answer you've given about whether a person made a serious or not a serious attempt in your view of nicotine dependence. A. I think there were two questions there. Q. I think there were more than two. A. Why don't I start with the last. Q. Sure. A. I think that to use the term "weak-willed" is as unfortunate as to use the term "addiction"; both are pejorative and both suggest some kind of moral failure on the part of an individual who may be smoking. The issue is that this issue is much larger than your narrowly focused discussion•of nicotine dependence. Whether people are able too quit smoking and how they manage to quit smoking is an issue that intersects many, many factors; some of which can be thought of as issues of a degree of physical dependence and others are thought of as matters of psychology, mind, spirit -- Q. Doctor? A. -- and -- yes. Q. I don't want to interrupt you but since time is short here I want to keep -- the focus of JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 100 A. No, I wouldn't. If you study; take a large scale population-based study, and you look at the outcome and make some kind of prediction about some. percentage of people who do this or that, it tells you absolutely nothing about a particular individual and what they will do or won't do. I don't think that anywhere you will find anything in the science of statistics that would argue or find that position to be controversial. MR. LAROCCA: Let me mark the next exhibit, Mayo Foundation Nicotine Dependence Center Patient Questionnaire. (Schwartz Exhibit 11, Mayo Foundation Nicotine Dependence Center Patient Questinnaire, marked for identification) Q. (By Mr. Larocca) Are you familiar with this questionnaire, Doctor? A. I don't think I've seen this questionnaire before. Where is this from? This is Appendix B to something. Q. All I know is really what's on the face of the document. It says -- A. This is not a document that was included in my materials. JUDI A. ROBERTS REPORTING SERVICE
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107 1 what I'm trying to get at is an assessment of 2 nicotine dependence, not a program to get people to 3 quit smoking; not whether it's going to be 4 successful or not; but you're ma king an initial 5 assessment of whether somebody is or is not, in your 6 view, nicotine dependent. And the question I was 7 trying to ask you is: what does the prior history of 8 whether you consider them to have a serious attempt 9 or a non serious attem pt, your characterization of 10 that, have to do with your assessment of nicotine 11 dependence? 12 A. If somebody can quit smoking by simply 13 deciding, I'm putting down this pack of cigarettes 14 and I'm not picking them up anymore. I think that 15 that seriously challenges the way in which you use 16 the term "nicotine dependence". 17 So the degree of the capacity to stop 18 smoking and the various elements that go into thatt 19 capacity, I think, are critical of any discussion of 20 nicotine dependence. 21 Q. You read Ms. McNally's deposition and you 22 talk about it in paragraph 9. Do you think she is 23 nicotine dependent? 24 A. I am unable to say from reading the 25 deposition whether,she's nicotine dependent or not. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 102 haven't reviewed the Mayo questionnaire, so I couldn't say. Q. What aspect- -- in what respect doesn't the Fagerstrom questionnaire provide the information that you're looking for in paragraph 12? A. Give me a moment to reread the Fagerstrom questionnaire. Q. Sure. A. (Witness reading document) Well, the Fagerstrom questionnaire doesn't answer any of the questions which I have said are necessary to know. For example, we need to know whether the individual ever seriously wanted to quit. The questionnaire doesn't ask that. Was motivated to do so; the questionnaire doesn't address that. Has ever made any significant attempt to do so or has any plan to do so in the future. I would add, if the questionnaire merely took those questions and added them to the questionnaire, that wouldn't be sufficient either. Q. Why not? A. Because people respond to questionnaires in a way that vastly over-simplifies what are very, very complicated issues of motivation and behavior choice. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 111 individuals? And let me ask it another way, which is: isn't it correct, under the way that you're approaching it, that you would never find anybody to be nicotine dependent because they could always do one more thing? A. Well, I think I would modify your final question to say that, no, I think that there are some individuals whom I would term "nicotine dependent", but, yes, I would always say that those individuals can do still another thing to stop smoking. That there is absolutely nothing about the designation "nicotine dependence" or "tobacco dependence" that should be taken to imply that people cannot stop smoking. And if you look at people who have been very, very heavy smokers, and I have known many in my professional and personal life who have said for years and years and years they can't stop smoking, and then they walk into a doctor's office and something has happened; they had developed a diagnosis, a serious diagnosis of cancer; well, all of a sudden they're able to stop. Now, I know that's universally true; some people don't stop in the face of that, even in the face of such catastrophic information. How could it JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 110 quantify it? In other words, if you said, I look at this twenty-six year old woman; I read what she said in her deposition; and my view is, she hasn't made a serious effort yet. But if she took steps X, Y and Z in the future, that would allow me to make an assessment whether she's nicotine dependent. She's trying; if she tried to quit ten times for a week at a time or if she tried to quit three more times and lasted six days, do you have any way of quantifying what it is you're talking about? A. I think that every time you try to come up with some set of rules and put it into one case or the other you wind up losing critical information about the individual. So, no, I don't think that there's any way that I could quantify it. I think, from my experience, that you need to speak to individuals. As it turns out, even the process of being deposed, when you're a plaintiff in such a matter, tends to generate information which was very revealing on these issues which I don't think can be quantified in the way that you are suggesting. Q. I understand your view, that you have to speak to individuals, but my question is: what do you want to learn when you speak to those JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 108 I am able to say that any claim that she might make that she is nicotine dependent and therefore unable to stop smoking is contradicted by much*of what she says in her deposition, which indicates she has not seriously attempted to quit smoking, has not persisted in efforts to quit smoking, has not spent time, energy and effort developing a motivation and a commitment to stop smoking. Q. So to summarize, she hasn't really tried hard enough, in your view? A. well, I think in this particular instance it is obvious she has not tried very hard. Q. So, again -- A. Cigarette smoking is not necessarily easy to give up for everybody. For some people it is harder to give up than for others. To simply say, well, I made some kind of an attempt and I really wasn't able to, therefore I can't, is an extrapolation from, I failed to do something, to, I cannot do something; that extrapolation is unwarranted. Q. Doctor, why can't you give me a view that she is not nicotine dependent. Is your view sort of an agnostic view; I don't know whether she's JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 112 be that a two-pack a day smoker who will tell you that I have been through countless efforts to quit, and I've been unable to do so and describes the difficulty that they had in withdrawal symptoms, walks into the doctor's office, receives a major scare, which they take seriously, walks out of the doctor's office, throws the pack of cigarettes away and has an absolute new determination they'll never smoke again. In fact, begins to postulatize the health effects of taking responsibility and never smoke again. Now, was that person dependent up to the minute that they threw their cigarettes away, but never dependent, not dependent any longer beyond that period of time. So that distinction doesn't really matter. The central issue is that the designation of a dependency, even the designation of addiction, any way that you define it, doesn't imply that a person, when sufficiently motivated can't stop smoking. The degree of motivation appears to be very, very different for different people. The degree of commitment to that motivation appears to be very, very different in people. There are different personality factors m m 00 JUDI A. ROBERTS REPORTING SERVICE m
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115 1 office and complains they smoke and want to stop get the diagnosis. Q. Doctor, I believe you said you had may 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 treated twenty-five patients? A. Approximately. Q. Approximately, during residency? A. During my residency and during the year following. Q. That was for nicotine dependence? A. That was, I labeled it then for smoking, and would now refer to it as tobacco dependence. Q. Did you diagnose all of those -- looking back on it, do you consider all of those people -- strike the question. Did you diagnose all of these people as nicotine dependent or since this time period of late seventies and early eighties or whatever? A. I really don't remember; it was a long time ago. Q. But you gave them medical treatment for smoking, right? A. Yes. Q. And you felt that medical treatment was warranted for each of those twenty-five people? A. I felt it was worth trying this JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 117 A. Beyond that earlier time in my career, 1979 to 1984, I, by and large, have not. There may have been a couple of"exceptions overall of these year. s which I don't recall. Q. But my follow-up: you can't look back on that, even that group of twenty-five that you treated, and say that you would today consider any of those to be nicotine dependent? A. What I'm saying is, I don't remember the details of those cases. They go back; the latest one would have been thirteen years ago. I presume that some of them would have qualified for that diagnosis. Q. Can you give me a profile. Try this one more time. Can you give me a profile of a person; concrete, real life situation: a person comes into your office, presents to you with a certain set of life experiences that would lead you to diagnose that person as nicotine dependent. A. I don't think I can give you a profile of such a person. If you want to talk about a hypothetical; if you want to give me a hypothetical, I can certainly respond as to whether I thought it qualified. Q. A person who smoked, is sixty years old; JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 116 particular treatment, yes. Q. what was the criteria that you used to decide that those twenty-five people required medical intervention to stop smoking? A. Anybody who presented to'me as smoking and desiring to try hypnosis in order to assist them to stop smoking, I would have been willing to try hypnosis, so that's a very broad criteria. Q. Looking back on it, and maybe you don't have a good enough recollection to answer this question, but would you consider any or all of those patients to be nicotine dependent from your vantage point today? A. I really could not say. I do not have the distinct memories of any of these cases.• Q. So is it fair to say, Doctor, that looking back on your entire career you have never treated a patient who you can look back on and say I considered this patient to be nicotine dependent? A. No, I have treated patients who I thought were likely to be nicotine dependent. I haven't treated them for their nicotine dependencies. I was involved in treating them for other purposes. Q. You have never diagnosed and treated a single patient for nicotine dependency, correct? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 121 truth; you'd write down a one for that correct? A. That's what the questionnaire requires, yes. Q. And then you ask the patient, "Which cigarette would you hate most to give up?" And the patient answers, "The first one in the morning." And you again think the patient is telling you the truth, and you'd write down another one for that, right? A. Yes. Q. And then you'd ask the patient, "How many cigarettes a day do you smoke?" And the patient answers you, "Thirty-one or more." You'd write a three for that, correct? A. Yes. Q. And then you'd ask the patient, do you smoke more frequently during the first hours after waking than during the rest of the day? And the patient says, yes. You give the patient one for that, correct? A. Yes. Q. And then finally the last question I'd ask, do you smoke if you were so ill that you were in bed most of the day? And the patient answers, yes, and you'd write down a one, correct? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 124 regard to? A. Hoskins, V. Reynolds and Arch. Q. If I might, if I could kind of lean over a little bit since those are the originals and the only ones produced and I don't have a copy. If I might refer you here to an entry on the second page dated 11/25. First of all, is this all your handwriting on these two pages? A. Yes. Q. "Eleven/twenty-five, affidavit review/changes"; is that an accurate reading of that entry? A. Yes. Q. Can you please tell me what changes were made to your affidavit that was in the Hoskins case? A. Sure. I think there were some typos and also a matter of the formatting of paragraphs. Q. And those were the only changes that were made? A. As best I can recall, yes. Q. Had you ever supplied a draft version of that affidavit to counsel? A. Yes, I did. Q. Can you tell me what happened to that draft affidavit? I believe we had requested copies JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 119 individual that's sixty years old, been smoking for forty-five years. I would like to understand the kind of effort this person has made to quit smoking. I'd like to question this person in detail about his experience while abstinent experiencing the withdrawal symptoms. I'd like to know if this person has ever attempted utilization of any special treatments, nicotine substitute treatments or programs to stop. I'd like to understand the patient's experience of the urge to smoke. And I'd like to know what was going on in their mind while they were making past quit attempts to, as they were approaching that point of relapse, what they were experiencing and what they were trying to do to help themselves. Given these, all of these issues coming together, and extreme set of withdrawal symptoms which were convincing, patients having made serious attempts repeatedly to quit and being unable to do so, attempts that were genuine and verifiably genuine, I could easily imagine making a determination that this person was tobacco dependent. That, somewhere in making that determination, the issue of whether the person, JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 113 which we haven't even begun to speak about. Some people are much more impulsive than others. Some people follow directions and respond to information delivered to them from authority figures, such as physicians; other people characterologically reject and struggle against information that is delivered from authority figures such as physicians. There are many, many, many factors that go into how people make decisions, to follow advice. Some people go into a doctor's office, hear the advice that the physician gives them and walk out and mischaracterize it immediately because of psychological mechanisms such as denial. Some people -- sorry, I got thrown off. Q. Doctor, have you ever met a smoker who you assessed as nicotine dependent? A. Yes. Q. Can you give me a profile of that person, please? A. It was a very long time ago when I was doing my hypnosis for smoking. Q. Back in your residency? A. Yes, residency and fellowship. Q. Back into the '79 through '83 time period? JUDI A. ROBERTS REPORTING SERVICE
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99 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 statement highlighted in yellow by me: "To our knowledge there are only two population-based studies of the prevalence and correlates of nicotine dependence using the DSM-IV criteria and only one using the Fagerstrom scale." So this statement is an extrapolation. A statement endorsing the Fagerstrom scale is apparently an extrapolation on the basis of only one population-based large scale study. Q. And I take it by your answer that you believe that large population-based studies are the most reliable? A. The most reliable for what purpose? Q. For predicting any of these factors. A. The only way to reliably predict the capacity to a degree to which any individual is independent in their capacity quit is to individually assess the patient. There's no large scale studies or questionnaires of any kind that can be reliably used for that purpose. Q. Again, that's your opinion, but you would acknowledge that the document you just read states the opposite with respect to the Fagerstrom questionnaire, correct? MR. NIMS: Objection. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 109 nicotine dependent or not nicotine dependent, or is it based on the factors she told me, I don't think she's nicotine dependent? . A. No, it's more the first case. I don't know on the basis of the information I have in front of me whether she is or is not. Q. What additional information would you need to know to decide whether in your mind she was nicotine dependent or not nicotine dependent? A. Well, I would certainly like to see a persistent, consistent development over time of her motivation and commitment to stop smoking. I'd like to see her take responsibility for that and make efforts to stop that are measurable. I'd like to understand what her experience, as she builds up to that, is. I'd like to know what her degree of belief in terms of her own ability to quit is, and how she marshals that belief, and a plan to engage in a number of behaviors that will help her to quit. While she's trying to quit, I'd like to kno,w what her self reported experience is. I'd like to know what the report of people around her have of what her quitting experience is. And, of course, I'd like to know the outcome. Q. Can you at all make that concrete or JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 118 they've been smoking since they were fifteen years old two packs a day; that fact alone; that's all you know about the person. Q• No, I couldn't say on that fact alone. Okay. Take that same circumstance, and -- well, you tell me what other facts could that person tell you, rather than my playing a guessing game with you. What other facts could that -- we now have a sixty year old who walked into your waiting room; he said, "Doctor, I've been smoking since I was fifteen years old. I smoke two packs a day for forty-five years." What additional facts could you elicit from this person that would lead you to a diagnosis that he is nicotine dependent? MR. NIMS: You mean, other than those he's already discussed a half an hour ago when he talked about all the things he'd want to know from a person, when you were questioning him about paragraph 12? MR. LAROCCA: Well, that was a very generalized, theoretical question. Q. (By Mr. Larocca) Now, can you give me specific facts? Maybe you can't do it. A. Well, let's construct a particular JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 126 Yeah, it was in the Hoskins case, I think. Q. Had you ever submitted a draft of your affidavit in the Arch case, in this particular case, to counsel? A. No. Q. Had you been asked to? A. No. MS. KNISELY: I'd like to mark this as Exhibit 13. (Schwartz Exhibit 13, Two pages of handwritten notes, marked for identification) Q. (By Ms. Knisely) Doctor, these are again, two pages of handwritten information that were produced in the documents today. First• of all, can you tell me what those pages are? A. These are notes that I made to myself that were reflections of various readings from articles which we've seen here today. Q. That is your handwriting? A. This is my handwriting. Q. Could you read the first paragraph for me. A. "Even if we compare addiction to nicotine to addiction to cocaine we find the enormous JUDI A. ROBERTS REPORTING SERVICE
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114 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A. Yes. Q. What was the profile of that person? A. I can't remember. Q. person in A. diagnosis treatment brings issues us How is it that you remember that this your mind was nicotine dependent? Well, it was necessary to give people the of nicotine dependency in order to begin a program for nicotine dependency, which around to one of the political and policy that have to do with the American Psychiatric Association, I believe, and other organizations coming to give tobacco addiction, quote, unquote, formal designation as a disorder. a You've got to have a formal designation as a disorder if you are going to be in a position to justify treatment, to give treatment and bill for treatment, et cetera. Most physicians, I believe, who treat people who smoke apply the designation in an extremely variable way. And, in fact, studies indicate, I don't think this is controversial, that the reliability of the diagnosis, whether you consider it dependence or addiction is not great, meaning that different people in their different practices don't use it across the board in a uniform and reliable way. Only somebody who comes into the JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 120 patient was able to quit despite the tobacco dependence is an issue which would have to be separately or additionally investigated. Q. Now, you have in front of you still the Fagerstrom test which we have marked as Schwartz 10? A. Yes. Q. Suppose a patient presents in your office, and we go down each of the six questions, and let's just do it here. The first question is, "How soon after you wake up do you smoke your first cigarette?" And the person says, "Within five minutes." A. Um-hum. Q. Let's say that, just for the sake of argument, you're actually filling out this Fagerstrom questionnaire as you're listening to this patient. For No. 1, you would give that patient three points, correct? A. That's how I'm instructed by this questionnaire to score the questionnaire, yes. Q. In the next one, the patient says -- you ask the patient, "Do you find it difficult from refraining from smoking in places where it's forbidden, et cetera?" And the patient tells you, "Yes." And you think the patient is telling you the JUDI A. ROBERTS REPORTING SERVICE
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123 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 a sustained quit attempt. Q. Okay, Doctor, I have no further questions. My colleague, Ms. Knisely is going to ask you a few questions. MR. LAROCCA: Before we do that, let me ask you this, though. I'd like to have two pages of what appears to be the same document, but we will let the Doctor take a look at it. Off the record. (Discussion off the record) MS. KNISELY: Back on the record. If we could identify these two pages as Schwartz 12. (Schwartz Exhibit 12, two pages of document, marked for identification) DIRECT-EXAMINATION BY MS. KNISELY: Q. Sir, can you tell me whose those pages are; again, they were the documents that were produced today; can you identify those for me, please? A. Yes. These are my records of the time that I have devoted to my consultation with Jones, Day and my bills and receipts for that time. Q. Okay. With what cases are they with JUDI A. ROBERTS REPORTING SERVICE
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128 1 A. I'm not sure that it's in question. I 2 -- mean 3 Q. In your opinion or belief, is it an 4 accurate statement as you sit here today? 5 A. What I'm saying is that it is a 6 controversial stat ement, and it is difficult to 7 assess . 8 Almost all mental health professionals 9 and substance abuse professionals have some contact 10 with individuals who use cocaine who have not gone 11 on to become addicted. There are people in the 12 field who argue that there are far more of them than 13 most substance abuse professionals would like to 14 admit. I think the controversy is unresolved. 15 Q. In your mind the controversy is still 16 unresolved? 17 A. In my mind the controversy is still 18 unresolved. I believe that there are more people 19 out there who have used cocaine and never reported 20 it, and therefore would fall into the class of 21 people who have us ed cocaine without becoming 22 addicted or depend ent upon cocaine. So though it is 23 a controversy that is, I guess I have a view about 24 it. 2511 Q. Let me try to understand, if I can, what JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 127 majority of the cocaine abusers have remained non-addicted, intermittent abusers." Q. Can you teil me where that -- first of all, is that statement an opinion of yours or belief of yours or did it come from someplace else? A. I can't tell you where it came from, but looking at this, these pages are quite old and my memory of them is not distinct. I believe that everything I wrote down here was something I was abstracting from some article that I had seen. Q. I notice in a lot of your notes you seemed to have done that. As you sit here today, and if you want to reread it, please feel free. As you sit here today, is that a belief or opinion that you hold? A. Well, I have to tell you, this is an area of great controversy, how many of cocaine abusers are out there who are just recreational abusers and how many people really become addicted to cocaine, and I think that it's an unresolved controversy, and I could only respond that way, it's an unresolved controversy. Q. But I'm saying, in your mind, in your opinion as to your belief, that statement is in question? JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 122 A. Yes. Q. And when you tally it up, you've got a score of ten, correct? A. I wasn't counting. Q. Let's do that to make sure my math is right. Three for the first, four, five, six, seven, eight, nine, ten; you got a score of ten. That's the very highest score you can get under this Fagerstrom test, correct? A. Apparently, yes. Q. And the Fagerstrom test says anything from eight to ten is very high for an indicator nicotine dependence, correct? A. That's what it says. Q. Now, you, Dr. Schwartz, would you of conclude on the basis of those six factors that that person is nicotine dependent? A. No. I would conclude that on a statistical basis, individuals who score highly have a higher likelihood, but that, in fact, without further investigation, one could not make a determination that individual was dependent. For instance, this questionnaire doesn't even ask if somebody has tried to quit or wants to quit or has experienced difficulty trying to quit in JUDI A. ROBERTS REPORTING SERVICE Ln ~ ~ ~ m m 00 w m
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 129 your particular opinion is. I understand there is a controversy out there, as you've indicated, but you're saying you're of the belief that there are more'people out there who use cocaine intermittently who are not addicted, and that the numbers of addictions to cocaine are overrated; is that what you're saying? A. Probably. I think that's probably the case, yes. Q. So when this quote, or I don't know if this is a quote word for word, but this intent or comment says that in addiction to cocaine we find an enormous majority of cocaine abusers have remained non-addicted, intermittent abusers, that means we're beyond enormous majority. In other words, this statement is saying, that in addiction to cocaine we find the enormous majority of the cocaine abusers have remained non-addicted, intermittent abusers. You're saying the number of people who are intermittent users who are not addicted is even higher than what this statement seems to indicate? A. No, I'm not. Q. Okay, then, that's my question. Do you believe that this statement is accurate? MR. NIMS: If you can answer that Ln ~ J J m 0) co W J JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 131 which is either a quote or a paraphrase taken from something else, than my opinion, and I honestly do not understand the question. Q. (By Ms. Knisely) Okay, let me approach it this way. A. Okay. Q. When you wrote or took excerpts or comments out of various articles, there were certain things you chose to excerpt or quote and certain things you chose not to? A. Of course. Q. And this particular comment you chose to excerpt? A. That's correct. Q. what criteria did you use, or why•was it important to you, or what significance did it have that you excerpted this particular comment? A. I have, obviously, during the time that I've been doing this consulting, excerpted hundreds, if not even thousands of statements that I found to be of interest in one way or another. I cannot go back and tell you what criteria I decided to excerpt, one thing versus another, or what I thought was relevant at one particular point in time and what I didn't think was relevant at another point in JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 134 about attribution theory in these notes, let me start with that. . It is widely.believed and thought of under the heading of attribution theory, that individuals who attribute their behaviors to themselves and behavioral change to internal factors rather than external factors, factors that they control, are more likely to successfully maintain whatever behavioral change that they are trying to engage in. And I write that this is central to the issue of motivation, the belief that one can control and is responsible for his or her own behavior. Now, one of the forms that shucking responsibility for your own behavior can take is a thing called defense mechanism known as projection, in which you attribute certain characteristics either to other people or to other things in the environment. So a classic example of projection might be, well, perhaps I'm angry with you but I have difficulty tolerating that sensation of anger and I kind of transform it in my mind to you're really trying to get me because you don't like me and you're angry with me. That's more tolerable for me to think unpleasant feelings and thoughts come from JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 135 you rather than they come from me. People, likewise, tend to project outside of them the capacity to control particular behaviors. So they are told by a, quote, "addiction", end quote, professional, that they are addicted and that is a disease for which they do not bare responsibility because addiction means that they can't control their behavior, so now they have lost volition and they come away thinking, because it's easier to tolerate that, well, it's really the fault of this substance or this company that manufactures the substance, and all of the people at the bar where I hang out who are always smoking and always handing me cigarettes, it's all kind of their fault rather than it's my fault. That's what I mean by projecting responsibility. Projection is not considered to be a particularly high order defense mechanism and projection correlates with failure to assume responsibility. Q. Is it fair to say then that it's your opinion or belief that acceptance of responsibility for one's own behavior is a good or healthy character? A. Yes. Ln ~ ~ J m Q1 00 W JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 140 A. Yes. Q. Can you read that statement for me, please? A. It's a quote, and it's in quotes. It says, "The selling of the idea of addiction is a major contributor to the undermining of moral values and behavior in our era." Q. Where is that quote from? A. It's from this book. Q. Were there any other quotes that you wrote out of that book, to your recollection? A. I really don't know. Q. When would you have written that quote out? A. I assume at the time that I read the book. Q. When would that have been? A. Many years ago. Q. What was it, if you recall, about that particular quote that you pulled out? A. You mean, why did I pull this quote out? Q. Yes. A. I pulled this quote out because it echoes a theme, perhaps somewhat more strongly than the way that I would state it, that addiction is, the Un ~ J J m JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 139 is willing to blame a condition of dependency or addiction for her failure to make significant efforts to change her behavior. Q. Doctor, you have produced here today a book; we wouldn't attach the whole book, but I would, however, ask the court reporter to make a photocopy of the title page and the inside cover of that book, inside back cover, the last page; it's entitled Diseasing of America, "Addiction Treatment Out of Control". Doctor, is this your book? A. That book does belong to me, yes. MS. KNISELY: The pages I have asked to have copied I would like to mark as Exhibit 15. (Schwartz Exhibit 15, Portions of book, marked for identification) Q. (By Ms. Knisely) Doctor, could you take a look at that book and tell me if that is, in fact, a book that was produced this morning? A. Yes. Q. If I point you, as I see you've already turned to the back inside cover, there's some information written in red? A. Yes. Q. Is that your handwriting? m 00 JUDI A. ROBERTS REPORTING SERVICE ~
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137 1 order to answer, I think I have to -- 2 Q. (By Ms. Knisely) Well then, let me pose 3 it more as a hypothetical. Let's assume that you 4 have a group of people who believe they are addicted 5 to cigarettes. Let's assume you have a group of 6 people who believe they are addicted by the conduct 7 of the cigarette manufacturer. Let's even assume 8 that these people have filed a lawsuit based upon 9 that belief. Are these people projecting the 10 responsibility for their smoking, thereby exhibiting 11 an unhealthy defense, as you've indicated when you 12 were describing an unhealthy defense? 13 MR. NIMS: Objection. 14 A. I can't answer the question the way in 15 which you posed it. 16 The issue in terms of projection is 17 whether an individual, believing that they are 18 dependent or addicted, believes that responsibility 19 for what they may perceive to be as their inability 20 to stop smoking comes from someplace else; that they 21 do not have responsibility for themselves. 22 An individual who believes that because I 23 have been given the diagnosis of addiction or a 24 diagnosis of dependency, I am unable to control my 25 behavior is a person who is refusing to assume JUDI A. ROBERTS REPORTING SERVICE.
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 138 responsibility for their behavior; a person who is placing the locus of control for their own health outside of themselves independently. It would depend on the particular person as to the degree to which the person blamed or projected their responsibility to an outside individual or company as opposed to their own behavior in having started the smoking and continued to smoke. Q. (By Ms. Knisely) would you say -- let's take it down to an individual, Ciaran McNally. You're familiar with Ciaran McNally, a plaintiff in this lawsuit? A. Yes. Q. You've read her deposition. Would you say that she, by saying that she can't stop smoking and that it's the result of being addicted to cigarette resulting from defendant's conduct, that she is projecting responsibility for her smoking? MR. NIMS: Objection. Q. (By Ms. Knisely) You can answer the question, Doctor. A. I haven't psychiatrically interviewed Ms. McNally. What I can say from her deposition is that it appears as though she is not assuming responsibility for stopping smoking. And that she JUDI A. ROBERTS REPORTING SERVICE Ln N ~ J m Ql co OP m
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 125 of all drafts and I did not see any in the documents produced today. A. I don't know what happened to that draft. I don't have a copy of that draft. But there was a draft that came back with some minor changes that were along those lines of typos and formatting. Q. When you say "along those lines"; were there any changes that were not typos or formatting? A. There may have been grammatical construction that wouldn't be considered typos. Q. And what did you do with those changes when the document on which those changes were made came back to you; did you just dispose of it you finished? A. I believe I did, yes. when Q. If I might, under the entry 12/6/96 it says, "review of reformatted affidavit". Can you tell me what that means? A. Well, to reform an affidavit, there were some matters of paragraph style and this and that. After it came back, a review of it was my reading of it. Q. Was that in the Arch case or the Hoskins case? A. I presume it was in the Hoskins case. JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 130 any better than you have. THE WITNESS: I just can't answer any better than I have. Q. (By Ms. Knisely) Are there an enormous majority of cocaine abusers who have remained non-addicted? A. I don't know. It is obviously believed by some people in the field to be the case. And I do believe that there are more non-addicted cocaine abusers out there than are known. There are more people who abuse cocaine than have reported it in any studies. But is that number enormous? I don't know. This particular statement happened to be a rather strong statement about a view that I partly hold, though with questions. Q. - What about the aspects of the comment where it says, even if we compare addiction to nicotine to addiction to cocaine in terms of numbers; are there more people who are addicted to tobacco or nicotine who use it than there are who are addicted to cocaine who use it? MR. NIMS: Objection. A. You know, you have really lost me. I'm not trying to be difficult, but I think you're trying to make much more out of that statement, JUDI A. ROBERTS REPORTING SERVICE
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 136 Q. And that a tendency to project responsibility is, as I believe you wrote there, an unhealthy defense? A. As a general rule, projection is an unhealthy defense, yes. Q. And in your opinion and your belief then people believing that they are addicted to cigarettes by the cigarette manufacturer's conduct, are those people projecting their responsibility and thereby exhibiting an unhealthy defense? A. we have to step back a little bit and say people who are addicted project addiction to the manufacturer. I would say that that's how I understand you posed the question to me. Q. Let me repeat it. A. Okay. Q. In your opinion or belief then, is it your opinion that people who file lawsuits or believe they're addicted, believe they are addicted to cigarettes because of the conduct of a cigarette manufacturer, that these people are projecting the responsibility for their smoking thereby exhibiting unhealthy defenses? MR. NIMS: Objection. A. That's a question of many parts which, in m 00 JUDI A. ROBERTS REPORTING SERVICE ~
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 141 concept of addiction is used in a way that I think has.a dilatorious effect of sense of responsibility. Q. Did you agree with the statement fully as it's written? A. No. Q. You say in your opinion that people who believe they are addicted to cigarettes as a result of the conduct of the cigarette manufacturers undermine the, quote, "moral values and behavior in our era"? MR. NIMS: Objection. A. That is so -- that statement lacks so much meaning that I simply can't respond to it. don't know what it means. I Q. (By Ms. Knisely) Well, Doctor, i-f I could borrow that book back for a second. You didn't seem to have much trouble understanding the quote that you copied out; am I correct? Maybe I should do it this way. Tell me, if you can, what this quote is; "The selling of the idea of addiction as a major contributor to the undermining of moral values and behavior in our era"; what is your.understanding of that sentence? A. I think that I have already answered that I copied that quote out because it touched a related JUDI A. ROBERTS REPORTING SERVICE
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142 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 thought which I think is important, which is, I think the degree to which the addiction issue is unfortunately often used to undermine individual personal sense of responsibility for changing behavior. That was the bell that got set off by that particular quote, as best I can remember it. I cannot account for Stanton Peele's broad observations about undermining moral values; I'm not sure what he meant by that statement. Q. Is there ever a situation where a person's addiction to a particular substance, whatever that might be, is, in fact, the result of the conduct of an outside person? MR. NIMS: Objection. Q. (By Ms. Knisely) An outside force? A. Well, I wouldn't know. I suppose if you tied somebody down and injected them with opiates, if you want to construct a hypothetical, I suppose one could say that one could become addicted as a result of an outside force. There are certainly conditions in which, and as I say "addicted", again I prefer the term "dependency". I think "addiction" is an unfortunate choice of words. There are medical situations in which Ln ~ J J m (31, co JUDI A. ROBERTS REPORTING SERVICE, m
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 133 Surgeon General's Report, but they also appear in other articles, original articles in the literature I pulled together. I can't say for certain. Q. Is all the writing on that document yours? A. Yes. Q. I would note than on page 2 at the bottom there are a number of comments made in red? A. Yes. Q. Can you please read those comments, please? A. Well, before the comments there's a whole paragraph that's outlined in red on attribution theory. The actual text is written in red. It says, "An element of character, acceptance of responsibility, internalization of responsibility, tendency to project responsibility, a primitive defense, unhealthy defense) correlates with failure to assume responsibility, to take charge of ones own behavior." Q. Doctor, we touched a little bit on this subject in your testimony earlier, but could you tell me specifically what you mean by those words, "tendency to project responsibility"? A. Yes. These comments follow my statement JUDI A. ROBERTS REPORTING SERVICE
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145 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 STATE OF CONNECTICUT JUDICIAL DISTRICT OF ---------------------- ------ ------------------- Harold I. Schwartz, M.D. Harold I. Schwartz, M.D. personally appeared before me at __________________I Connecticut, this ________ day of................. ' 1997 made oath and acknowledged this deposition to be a true and accurate transcription of his testimony. ----------------------- NOTARY PUBLIC My Commission Expires: JUDI A. ROBERTS REPORTING SERVICE
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132 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 time. Q. Doctor, there's another document which I would like to mark as 'Exhibit 14, and it's two pages. I would like you to refer, if I could, to page 2 of that document. That was also produced in the documents. (Schwartz Exhibit 14, Two pages of handwritten notes, marked for identification) Q. (By Ms. Knisely) If I could refer you -- first, if you could identify those two pages for me, please. A. These are additional pages of notes which I made while reading documents. This page, this is a two-page note stapled together, and I have a heading on the top that says "Surgeon General's Report". Q. Does the second -- page if you would look at the page 2; does that second page refer to your review of the Surgeon General's Report as well or does it refer to some review of something else? A. I can't say with certainty. The elements here, that is, studies by Bandura about self-efficacy and comments about attribution theory, certainly appear in certain sections of the 1988 Ln ~ J J m JUDI A. ROBERTS REPORTING SERVICE ,
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 143 people are treated with opiates for relief of pain and which, following the best advice and the best writing of the doctor's orders, an individual may develop a dependence separate and apart from the kind of a volitional substance abuse. Q• Doctor, do you think that psychiatric counseling would be a necessary component or part of any successful smoking cessation program? A. There are a variety of smoking cessation techniques that appear to be effective, and some of them would include what would more traditionally be thought of as counseling and others do not. Q. Could you list for me those that you think are successful smoking cessation programs? A. I don't think that I can make an all exclusive list. Q. Could you list, as you sit here, what comes to mind? A. There are various behavioral programs that seem to have an effect; programs that focus on cognitive-behavioral techniques; programs that usually combine nicotine substitute delivery devices in conjunction with psycho education, and behavioral techniques seem to be effective in assisting a certain portion of people to succeed. There are JUDI A. ROBERTS REPORTING SERVICE
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( 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 144 articles in the literature that argue that the mere passage of information from doctor to patient constitutes, if you will, a program that is effective for some, non-effective for others. MS. KNISELY: I think we're done. Thank you, Doctor. (Time noted: 3:30 P.M.) JUDI A. ROBERTS REPORTING SERVICE
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148 1 EXHIBIT INDEX Cont'd 2 Schwartz Exhibits Page 3 4 5 13 Two pages of handwritten notes ...... 126 6 14 Two pages of handwritten notes ...... 132 7 15 Portions of book .................... 139 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ~ 25 i--, i JUDI A. ROBERTS REPORTING SERVICE
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SCHEDULE "A" (1) All C.V.'s or resumes prepared by or concerning Dr. Schwartz from the period of January 1, 1992 to tZe present. (2) All draft---copies of Dr. Schwartz's affidavit of January 20, 1997; (3) Any and all correspondence, documents or other written materials received by Dr. Schwartz from any of the defendants' attorneys in this litigation, in the litigation captioned Stewart- Lomanitz. et al v. Brown & Williamson Tobacco Corti. et al, No. 96- 110953 (Supreme Court, State of New York), or any other case where Dr. Schwartz has been retained by or testified on behalf of a tobacco company or its lawyers; (4) Any and all documents, writings or other tangible items received by Dr. Schwartz relating to this litigation, including but not limited to, medical records, medical/scientific literature, pleadings, deposition transcripts, memoranda, correspondence, expert reports (including preliminary reports and/or drafts), articles, videotapes, handouts, etc.; (5) Any and all materials, documents, writings, textbooks, medical/scientific literature, learned treatises or other tangible objects which formed the basis of, or was relied upon as support for, the opinion rendered by Dr. Schwartz in his affidavit of January 20, 1997 in this case; (6) Any and all notes made by Dr. Schwartz relating to this litigation including, but not limited to, his review of denosition transcripts, medical records or other materials reviewed by him for the 3
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ARN LEVI ' JONATHAN SHUB Levin, Fishbein, Sedran & Berman 320 Walnut Street Suite 600 Philadelphia, PA 19106 (215) 592-1500 THOMAS E. MELLON, JR. Mellon, Webster & Mellon 87-89 North Broad Street Doylestown, PA 18901 (215) 348-7700 STEPHEN A. SHELLER Sheller, Ludwig & Badey 1528 Walnut Street Philadelphia, PA 19102 (215) 546-7300 JULIA MCINERNY Coale & Van Susteren 5335 Wisconsin Avenue, N.W. Suite 720 Washington, DC 20015 (202) 686-6500 GARY ROBERT FINE Rodham & Fine, P.A. 633 Southeast Third Avenue Suite 4R Fort Lauderdale, FL 33301 (954) 467-5440 Attorneys for Plaintiffs
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~WAC#10 ' -_ 10 • ; ~~~•~ I hereby certify that on this 14th day of February, 1997, a true and correct copy of -the foregoing Notice of Deposition was served on all counsel by facsimile and first class mail, postage pre-paid. Jeanne L. Rensberger` u
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146 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 QL8Z1E1-Q$TFt I hereby certify that I am a Notary Public, in and for the State of Connecticut, duly commissioned and qualified to administer oaths. I further certify that the deponent named in the foregoing deposition was by me duly sworn, and thereupon testified as appeared in the foregoing deposition; that said deposition was taken by me stenographically in the presence of counsel and reduced to typewriting under my direction, and the foregoing is a true and accurate transcript of the testimony. I further certify that I am neither of counsel nor attorney to either of the parties to said suit, nor am I am employee of either party to said suit, nor of either counsel in said suit, nor am I interested in the outcome of said cause. Witness my hand and seal as Notary Public, this 20th of February, 1997: ATRo ts, CSR No. 020 Repo er - Notary Public My Commission Expires: Ln August, 1997 J ~ m m OD Ln it- JUDI A. ROBERTS REPORTING SERVICE
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purpose of reaching any opinion to be given in this case; (7) Any and all exhibits used as a summary of or support for Schwartz's opinion in this case; (8) Any and a3-l documents referencing the compensation Dr. Dr. Schwartz has been paid, will be paid, or which reflect his billings for: (1) his work on this case; (2) his work in the litigation captioned Stewart-Lomanitz, et al v. Brown & Williamson Tobacco Coro. et al, No. 96-110953 (Supreme Court State of New York); or (3) his work in any other case where he has been retained by or testified on behalf of a tobacco company or its lawyers; (9) A list of all other cases in which Dr. Schwartz has testified at trial or by deposition within the past four (4) years; (10) Any and all transcripts of any prior testimony (deposition in court or affidavit) given by Dr. Schwartz within the past four (4) years; (11) Any and all documents reflecting Dr. Schwartz's comments, critiques, suggestions, etc. regarding any drafts or final version of any Surgeon General's Report; (12) A11 brochures, advertisements and other documents which describe the Institute of Living, and all documents which describe Dr. Schwartz's responsibilities at the Institute of Living. 4
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New York [sw lournal, January 9, 1992 Page 5 access Dr. Schwarts' conclusion that the release was improper. It is totally conclusory without factual or objective support and is therefore unacceptable. Lastly, claimant may have another remedy, to wit, an action against the New York City 2ransit 1luthority. of course, assuming, as claimant has suggested, that Ke. Boyd jumped in front of the train, claimant's likelihood of success in such action is obviously questionable. Based on the torogoing, the motion is denied, but is without prejudice to renewal based on an expQrt affirmation or affidavit that complies with this opinion. Order signed. LuNcvAGE: ERCLISa
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IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA STEVEN R. ARCH, et al. Plaintiffs, V. - THE AMERICAN TOBACCO COMPANY, et al. Def endants . . CIVIL ACTION . No. 96-5903-CN PLAINTIFFS' NOTICE OF DEPOSITIONS - NO. 1 PLEASE TAKE NOTICE that plaintiffs will take the following deposition: Witness Location Harold I. Schwartz, M.D. Hartford Sheraton Hotel 315 Trumbull Street Hartford, CT 06103 Date Time February 19, 1997 10:00 a.m. Dr. Schwartz is requested to produce to plaintiffs at or before his deposition the documents attached hereto. , ROBERT J. LAROCCA scribed in Schedule A .. NAST 'JE?,NNE L. RENSBERGER Roda & Nast, P.C. 36 East King Street Daza: February 11, 1?9" Suite 301 _a::cast8= ??. 1-503 k717) -39:-1700
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147 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Page Direct-examination by-Mr. Direct-examination by Ms. Larocca ...............4 Knisely ............. 123 EXHIBIT INDEX Schwartz Exhibits Page 1 Notice of Deposition ..................4 2 Curriculum vitae ......................8 3 Article from New York Law Journal....13 4 Brochure .............................27 5A-J Inserts ..............................27 6 Supplement to The American Journal of Psychiatry ........................68 7 Copies of brochures on substance abuse ................................70 7A Original Brochure....................71 8 1988 Report of Surgeon General.......81 9A-L Memorandum...........................86 10 Fagerstrom Test for Nicotine Dependence ...........................92 11 Mayo Foundation Nicotine Dependence Center Patient Questionnaire........ 100 12 Two pages of documents ..............123 25 JUDI A. ROBERTS REPORTING SERVICE,
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PLEASE NOTE All telephone numbers at The Institute of Living have recently been changed as has the area code for much of Connecticut. We apologize for any inconvenience while we are reprinting the information sheets about our various programs. For correct telephone numbers please use the enclosed Programs and Services sheet (dark green border). The main number for The Institute of Living is: 860-545-7000
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BEHAVIORAL HEALTH HOME CARE OPTION PHILOSOPHY The Institute of Living, Hartford Hospital's Mental Health Network, and VNA Health Care have combined resources in the development of a state-wide home care product for customers in need of behavioral health services. The Behavioral HealtFi"Home Care Option (BHHCO) provides individualized services to clients of all ages for the purpose of stabilizing and maintaining them in their home environment. Services are planned, implemented and evaluated through a continuum of care that supports the philosophy of the partnership and . highest standards of clinical practice. GOALS • Maximize client independence through comprehensive assessment and individualized home care plans of treatment. • Decrease recidivism through early intervention and an interdisciplinary approach to case management. • Reduce health care costs and maximize community resources through an integrated system of care delivery. ADMISSION CRITERIA The following criteria will determine eligibility for admission into the program: • Clients will be under the care of a licensed psychiatrist/physician who approves the need for home care and agrees to a plan for crisis intervention. • A temporary or permanent residence wherein home care services can be performed must be identified. • Clients must voluntarily agree to participate in this level of care. • There must be available funding to pay for services. • A capable and responsible individual, friend or family member, must be designated as an available caregiver who assumes responsibility when home care staff are not present in the home. SCOPE OF SERVICE All services are provided under the care of licensed professionals, including Psychiatric Nurses, Psychiatric Clinical Nurse Specialists, Medical and Psychiatric Social Workers, Psychiatric Occupational Therapists, Registered Physical Therapists, Registered Dietitians, and Certified Home Health Aides who assist clients with personal care and activities of daily living. Specialized services are available in, but not limited to, the following areas: • Medication non-compliance • Crisis intervention • Discharge planning • Access to community resources • Obstetric or gynecological issues • Oncology related problems • Eating Disorders • Chemical dependency or substance abuse • Loss or trauma • Family coping and developmental issues • Maturational or situational crises • Problems of parenting -• Disorganization, confusion and problems of aging REFERRALS MAY BE DIRECTED TO VNA ADMISSIONS 1-800-862-1551 or THE INSTITUTE OF LIVING ASSESSMENT CENTER 1-800-673-2411 24 HOURS A DAY - 7 DAYS A WEEK NAOMI NASSHAN, RN,MS, PROGRAM MANAGER (860) 545-7889 ACCREDITED BY THE JOINT COMMISSION ON ACCREDITATION OF HEALTH CARE ORGANIZATIONS (JCAHO) THE INSTITUTE OF LIVING Hartford Hospital's Mental Health Nenvork i iWWth Care 400 Washington Street 0 Hartford, Connecticut 06106
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PROGRAMS AND SERVICES OF THE INSTITUTE OF LIVING ~ PLAINiIFi'S DEPOSITION ~ EXHIBR PROGRAMS* ., For Program/8ervice For 24 hr/day Referral/Admission InfonnaUon Contact: Contact: General Adult Programs Patricia Rehmer, M.S.N., C.S. 1-800-673-2411 (860) 545-7074 Addiction Recovery Service Paula Ruth, R.N., C.C.D.N. 1-800-673-2411 (860) 545-7196 Child and Adolescent Programs Vicky Aldrich, C.I.S.W., A.C.S.W. 1-800-673-2411 (860) 545-7020 Eating Disorders Program Margo Maine, Ph.D. 1-800-673-2411 (860) 545-7203 Geriatric Program Eugene Hickey, C.I.S.W. 1-800-673-2411 (860) 545-7219 Professionals' Program Heidi McCloskey, M.S.N. 1-800-673-2411 (860) 545-7061 . SPECIALTY SERVICES Behavioral Health Home Care Option Naomi Nasshan, R.N., M.S. 1-800-673-2411 (860) 545-7889 Crisis Intervention Service Annetta Caplinger, M.S.N. 1-800-673-2411 (860) 545-7200 Outpatient Services • Child and Adolescent Harry Hernandez, C.I.S.W. 1-800-673-2411 (860) 545-7065 • Adult.(English speaking) Kate Calvin, C.I.S.W. 1-800-673-2411 (860) 545-2716 • Adult (Spanish speaking) David LaCoss, C.I.S.W. 1-800-673-2411 (860) 545-2716 Special Education Service Grace S. Webb School Rosemary Baggish, M.Ed., M.P.H. (860) 545-7093 Gary Johnson, M.S. (860) 545-7207 • Laboratory Classroom Residential Services Edward French, C.I.S.W., A.C.S.W. (860) 545-7036 • Adolescent, Young Adult, Adult, Long-Term (860) 545-7036 ' All programs include inpatient, partial hospital, and outpatient components. Addiction Recovety Service also includes Aftercare and Ambulatory Detoxification. THE INSTITUTE OF LIVING Hartford Hospital's Mental Health Network 400 WashIngton Street • Hartford, Connecticut 06106 dlsk.foct sneets P&SFact.doC 12-96
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PARTIAL HOSPITAL PROGRAVS A V -i l-iL INST 1-TU-i L 01' l_IVING Patients live at home while obtaining care during part of the day. The philosophy of the Partial Hospital Programs at The Institute of Living is based on the belief that patients are best served when treated in the least restrictive environment, and encouraged to attain their highest level of individual functioning. The programs are based on a case management model, utilizing ongoing relationships-with the primary therapist in the community to support continuity of care for the patients. • Admission to all programs includes free assessment. • Programs offer conjoined services when appropriate. • Commercial insurance, HMOs, Blue Cross/Shield and Medicare/Medicaid coverage is accepted in all programs. • Program tours are welcomed. • Transportation can be made available on a regional basis. FOR INFORMATION REGARDING ANY OF THE PARTIAL HOSPITAL PROGRAMS OR SERVICES. CONTACT THE PROGRAM MANAGERS LISTED BELOW PROGRAM Child Partial Hospital Program (Ages 5-12) PROGRAM MANAGER/PHONE Allen Carter, Ph.D. 241-8000, ext. 6622 Adolescent Program (Ages 13-18) The Enfield Partial Hospital Program for Adolescents Eating Disorders Partial Hospital Program • Adults and adolescents • Day and evening programs The Comprehensive Adult Partial Hospital Program (Ages 18-60) • Dual Diagnosis Track • Trauma Specialty Track Psychiatric Acute Day Treatment (PAD) • Adult, short-term focused stepdown from inpatient hospitalization Chemical Dependency Partial Hospital Program • Day and evening programs Project Recovery/Cuidate Mujer • Bilingual/bicultural addiction treatment for pregnant and postpartum women The Partial Hospital Program for Professionals Geriatric Partial Hospital Program (Ages 60 and older) The Farmington Valley Geriatric Partial Hospital Program Ann Kramer, MSN. CS 241-6890 Nancy Jarasek. MS. RN. CS 253-6863 Robert Weinstein. Ph.D. 241-6896 Beth Pizzuto, M.S.N. 241-6870 Jackie Gunning, R.N.. M.S., C.S. 241-8064 Bonnie Fraley, M.S. 241-6903 Paula Ruth, R.N., C.D.N.S. 241-6903 Ln N ~ Barbara Bugella. R.N.. M.S.N. _J 241-8061 m m Alice Parker, R.N. 00 241-6880 Alice Reilly, C.I.S.W. 678-8551 00 N 1 I THE INSTITUTE OF LIVING 400 Washinqton Street • Hartford, Connecticut 06106 Hartford Hospital's Mental Health Netmork
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U2'18i87 TUE 16:43 FAX 2128160477 GOODKIND.L.K&S i0Uu Page 3 3RD STORY of Level i printed in FOLL format. Copyright 1992 New York Law Publishing Company New York Law Journal January 9, 1992•, Thursday SECTION: COURT DECISIONS; Pg. 21 LENGTH: 1032 words HaADLINEr Lack of Guardian Does Not Relieve Obligation to File Notice of Claim; Natter of Davis (State of New York), Court of Claims, Judge G. Weisberg. BODY: SUMMARY New York State CLAIMAliT, AS GUARDIAN ad litem for her daughter, moved for leave to file a late notice of claim in an action for medical malpractice by defendant state hospital. The court denied the motion, holding that the claimant was not relieved of the obligation to file a claim merely because she was not appointed guardian until after the end of the 90-day period. It also found that claimant's expert affidavit of merit failed to offer any facts or standards with which to assess the affiant's conclusions. COURT OF CLAIMS Judge 0. Weisberg 101TTaA OT DAVIS (State of New York) -- Claimant, Nilhslmena Davis, as guardian ad litem of Betty Boyd, moves for leave to file a late claim pursuant to Court of Claims Act S10(6). The application is denied. From the papers it appears that on February 1, 1991, Ms. Boyd was discharged from South Beach Psychiatric Center, a facility of the Office of Mental Health of the State of New York. A few days later she allegedly jumped in front of a New York City subway train, resulting in the injuries for which she now seeks commpensation. Addressing the factors specified in Court of Claims Act $10(6), claisant's excuse for having failed to caenwnee the action within 90 days of accrual is that the injuries to Ms. Boyd necessitated the appointment of a guardian ad litem which was not accomplished until May 9, 1991, i.e., after the 90 day period had expired. No explanation is offered why Ms. Davis, Ms. Boyd's mother, could not have filed a notice of intention to file a claim within the 90 day period. Appointswnt of a representative is not prerequisite to such an act (Katter of .Tohuson v. 8tate or New zork. 49 AD2d 136), and it would have extended claimant's time to commence this action for two years after accrual. (Court of Claims Act S10(3).) We therefore find clainant's delay inexcusable. The next factors are whether the State had notice of the essential f acts of the claim during the 90 day period, an opportunity to investigate and whether it would suffer substantial prejudice now if the application were granted. d rU1N1T m ~DEgSITION z3
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Outpatient treatment Eating Disorders Program Outpatient programs Vowecl religious prolessionals Residential Programs The Grace S. Webb Schcwl Eating I)isordcrs Day Aflective disorders hnpairecl physicians I3uckingharn for elementary middle, and Hospital , high school students Anxiety disorders The Nurses Program The Barnard Inpatient care Couples and families Stress management Maple Avenue Consultation Services Outpatient care counselin}; Case Management Services l Residential services Chemical clepenclency Ps cholo ical and Psychopharmaccr olry y g (including outpatient Neuropsychological Forensics Forensic Services detoxification) Evaluation Young Adult Program General psychiatry Adult Child and aciolescent Inpatient. Child and adolescent ( :I t ild/Adolescent prc>l;rams Rehabilitation Services and Outpatient psycLiatry F::uing disorclers Occupational Therapy Residential Impaired prolessionals Geriatric Services (:eriatrics Ilurticnllural therapy Sexual clisur(lers (:eriauie I)ay'1're:wnenl wumeu's issuc. 1 •i(i- skills anel thcrape•utic rccre:uiein Hamilv Iaw N9eelialie~n ( :c.nler Service lnpatient sctvicc s The Pro~ rram for ( )crupatiuna ancl vocaliunal disorders Eatin ' , Professionals evaluatiem g :11ihcintcr . As.urs.tinte•nl Geriatric psy(hiauy (:linic 1)ay "I're:ument (:enter I'svchiatric rneclicine Outpatient treatment and Residential services consultatiort (:hemical elepenclanc•y Wrllnc•ss prol;ramv i I LL89 OLLtS ®
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COMPREHENSIVE ADUL_T F'AR-i IAl_ F--IOSPITAI _ PRC)GHAM ; A7 ~f iE If~;~~ 1 I 1~) I f ~)f I I~i~f1C PHILOSOPHY The Adult Partial Hospital is a comprehensive group therapy program that helps patients to attain their highest level of functioning. In treatment, patients evaluate and modify their behavior, thereby improving their interpersonal relationships, use of leisure time, vocational pursuits and general mental health. The program emphasizes relapse prevention, and also helps patients to reintegrate into the community and to utilize community supports. TREATMENT SETTINGS • The Adult Partial Hospital Day Program Monday-Friday, 9:00 A.M. to 3:00 P.M. • Structured outpatient programming (limited) TYPES OF PROGRAMMING • General Adult Track • Trauma Specialty Track • Dual Diagnosis Track TREATMENT • Case management model • Group psychotherapy (patients participate in 4 to 6 groups a day) • Vocational testing; on-grounds constructive workshop and work sites with liaisons to the community • Family support, education and counseling • Continuation of existing relationships with individual therapists INFORMATION AND REFERRALS For additional information, call Program Manager Beth Pizzuto, R.N., M.S.N. (203) 241-6943 To make a referral, call ~ ryAN'R~ GKYdNww 11 ..iII -- The Institute of Living's Patient Services Office (203) 241-6900, or (1-800) 673-2411 I , . T INSTITUTE OF IrIVING 400 Washington str..t • Hartford, Conn.oticut 06106 ord Hospital's Mental Health Network eo.pll6aowc.e *a
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SERVICES C:ONSUL.TAi~ION rll/re• lre..lileele• :. ('uu.valletlieerr ,tie•rrie•a w;L.crc:uc•cl tu 1)ruviclc• sccc>nc1 c>l)iniunS iu elillicult casc•ti c•ncuuLttcn•eI hti, lit ivatc• I)rartitic>nc•r.r, as w•c•Il as uttr e>wn clinic ivts; te> e>Ifer su};p'cstic)Its c'e>nrcrning clia};uu.iS, tttCtliratie)n :tncl trc•attuc•Itt u> I)raclitic>ncrs :uul e linician.; tu Ix•rli)nn sl>c•cialt}' t•valu:uiuus lirr Ilu• I>tll>lic atul ne)nc linical rc•1i•rrc•rs; antl Ie> cxtruel'1'Itc Ittstiltutc•'ti Na.tit :u raN, e)f .atc•cialtv knuwlrtta{c ancl c•xlx t ic•uWc• to ttlc• ce)utlnttuit%. Sc•r%•in}{ a. <utlsult:utts ;uc• sunu• ul I lu• Instittuc•'s uu>re• sc•uiur :utcl c•xlu•ric•nF•t•11 cliuic ianti. TI>t•y :Ln• a,.ailal)Ir lu e>Ifc•r acl%i( c anel ulrinie>ns ill a I)nv.ul N:u irt). e>I .I>re ialtie•s, inc ILUeling ,tlrullul anel e ltcuticxl <Ic•Ix•ndc•tucy, };c•t iau ie I>.~i ltiauv, cltikl ancl aelcLlczcc•ttt IrsqchiarrN, Iantilv%nctrital axsc.Snu•LLt, liuttilq lativ Inc•cliaticm, crating clisurtlcr., furcttsic I>s}rltiatry (buth aclult ancl (l7ildj:LCk>Icscc•nt), l;c•ttcral Itsyc ltiatu}'. strc•ss nnanal;rtttcnt, iutl>aircd Ittu/c.siunal. (incluelin}; clc•r};y, It1t`'siciatts, ancl ntuse•s), ItIu71)ia., I)syc1uLl)hartrtace)le>}ry, ancl sc•xu:tl elise>rtlcrs. '1'ltc l:uusuluttiutt tic•rvicc is cnric ltc•cl 1>% 'I'Itc Ittxtiurtc•'s al)ilitN tu ctmcluct lull tu•urulu};ic• wv>rkul>s, incluclin}; Ma};tu•tic Rcsun:Lncc ltna};in;; (Mltl), Sinl;lc I'Ite7tutu 1•:utissiuu Cuntlxucriial Tutnu};raltlty (SI'E(;1'), (:N7' sc:uts, ce)utllutcriic•cl EE(:s, vul a Itattc•ty uf Itsychulul;ical .uul uc•tuul>Syrhult>gical tests. C:UNSULI Alii)N SE'HVICE:S F%1F.ND 7HF ItJSflTlllE'S `iKIL.I. ANl) F.%I'EHWNCE: f3F:Y'ONU iJ1.IF/ CATE•.-a ANU INTO I11[, i:6MMlJNITY. 0L89 OLLIS 0 I
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U:, 16 %b'/ llb 10:-14 t:1S :l.oioutii i bUULAi•`L•" -nacJ New York Law Jnumal, )aDUary 9, 1992 Page 4 Defendant claims a lack of knowledge and prejudice based on the assertion that it was not notified of the accident within the 90 day period. Claimant counters that the State had actual, timely knowledge of Ms. soyd's care and treatment inasmuch as it provided it. Both are in part right and in part wrong because both misperceive the test. - Claimant's proposed cause of action sound in negligence and medical malpractice based on defendant's release of Ma. Boyd on February 1, 1991. Obviously the State knew it released Ms. Boyd on such date. Equally, obviously, until notified of the February 3 subway incident, it would not have known there was anything to investigate. Having learned of the accident subsequently, since defendant has claimant's medical records, it can now investigate the ciroumstancss of her release. As to the subway mishap itself, aside from being tangential to the question of the State's negligence, defendant has been provided with an accident report which describes the incident and includes the name of the New York city transit officer who prepared it. In light thereof, the State's conclusory allegation of prejudice is insufficient. Thus, while defendant did not have timely notice of the subway accident, its present ability to investigate it coupled with its participation in Ms. Boyd's release and its records thereof establish a lack of substantial prejudice. As to an appearance of merit, claimant's initial motion papers did not include an expert affidavit of merit. When defendant raised this defect, in reply claimant submitted the affirmation of Dr. Harold eehwarts, a physician licensed in ths state of Connecticut. Dr. Scbwarts opined that based on his review of Ms. Boyd's medical records, that her discharge on February 1, 1991 would "appear" to have "constituted deviations from commonly accepted psychiatric and hospital practice. . . (which bears) a causal relationship with the injuries which the patient subsequently received." The State first objects to the sufficiency of this submission based upon the fact that Dr. Schwartt is licensed in Conn:eticut and fails to state that he is boared certified in psychiatry. Neither constitutes grounds, per se, for exclusion and go only to the weight of the affirmation. (Hall v. yonkeri Professional sospital, 115 A02d 637.) In the absence of any proof by defendant that Dr. BehMarts is unqualified to offer an opinion, we accept his qualifications for the pirpose of this motion. Defendant also argus that Dr. scbwsrts' opinion is conelusory in violation of the rule we set forth in Favicchio v. State of New York (144 Kiac 2d 212). Faviechio was also a petition to file a late claim in a medical malpractice action. There the expert stated that he had examined the claimant's medical records; that there was a departure from good and accepted medical practice; and that such was a substantial contributing factor in causing the injury to the claimant. Significantly, the affidavit did not contain a single fact concerning the care that the claimant had received nor why or how it was a departure from proper treatment. It was totally conclusory and offered no objective basis upon which we could evaluate it. While the instant affirmation is not as bad, it also suffers from several of the same defects. It does tell us what the departure was: Ms. Boyd's release on February 1. However, we are offered no other facts or standards with which to
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~:.All.'il.f.l ~V 1.1/1 iN0-:.:I-:.1N,~'- ICr IIIWHV•.5 =3-11 AH O 7'~>I`.\' IVEi itlV Anc- ~l•::u ar.V ."N31~)S Ir.lturlc(.,.>x.> Ill •>Itlrlnr,rw sr rlntirillett(IzlllI uLl.>1-;iru,l y.~inrrtltlr',1{Ir.lttu!t~cln. .ell atun tn.>tlecltli .ltu/ tu, .ien .H> t{t.;in:>I .,.~Srr.»r ,ItLI. ';slnua. .>.vstr.>tln s.,l r. nt lu.>lulr..,.tl l,~ .un.1~1 p:>lenll!.~.>.u/'p.~n{t~ll!tx .illr..iip.>tu .x{ cll sl>:).>It I,tl+l tlt.nn!d r. url :>Ir.t.tr1l,.Irllhr :>t{ Xr.tn nlnll!nll!liris/,y 1•>t.ul 'laul .)tyt Ill t.r.rlt .>.te.> {o tu.>ls~x .n.nr.ill.>,'url ti,,1r.{url rnXlnt.mlla.t{a.>I.tn.r.>/I suu~.v.iarpn lu.rr~urlur r~. uuy _LN3I1VdNI .1.>Ilu, Ill {>.>.1:>IIo .xit.r.xlx.> I>It>!'.,i.>L~L>. t;iaul {<, ,~;ir.lur..~l>e .>yl!t .rc> utln.~.>.ttll .t.>t{it.> Ill tt Il"in<Inli .>.u>tu ut lnantA 1! 'Xnt,ac,l{1! %i am:ilu Ilt.>ts,(s attlu.> .,t{.1. 'u<>tte.ln{> Ill patillttl plre ot 1>a1L"{tx:>p Intc'SI>amn :>ilt:>.xls. ttr.>tlr./i tl:m..> ss.>.r{11>e cri I>:>.lu{tr.l 1>.>tt{ertl>t.y{lut .>.w aml/l lu.>trnr..,.l.l. '1lt.,ll1'II rl ,1'., .p 11 Irr.,lnlr.rll Irr •sull/, l..ul .,rll yLUtrnnlt.rl.,ll II! ./1rr1 e,wIII III'.1..,1 Ie.,tYulc,tl.,iull,.lrl.>tt i,lre Ir..n st,l/,rl.,.~scl {,tre ele{, Ie.nYniutrrl.,.,l '.>leurlu.ulllr. n•>tl.m 'llrlr. ";.,i.rnItitt{ ler.>/,. I,trt! .%Irntl'.1 'tinurn!nlr..~.> Ir>tl~.>I~ •s.>.,.trt/,..>.r {,nr. .>tutl .>{i{trtle.% ; r>ilsr.,u {,irrw c,t .%ILr:xIN.> {,.itrt.ull.r.xl :>/I l.nrtr letll Itr.nttnv.>.rt 11, .> {cl. Ir. >Illr., tr sr tirsnu~el(1 ttter irl,rrl .tn .r./L~.r.,ti e rllr~, xln.>mx{ .:,Il ,lr.nr Strl!r>rurl., I/.>Iltys %cl I,.>rrl u,l l.,tl ttr.nti...,.~tr suur.aurlnv-.I.ul .,rll 'tn.>t.'~, .~ ntl., Ir, 1171 rr,ll .,nn•, rnu rl inrl.tl{1 •Is.rr.l n'x.> I,Irt, Il.,illrr r.,11s c til s.., u,rrl Ilt.ltrlsc.,cat .,tll '.,.IC, Ir, rtr.,ls.iti .>val.,l{.,ulnrll r . ~rn~r1.141 .,tnln~u{ .,tl.l l/lut .1.r~n.r ~i> ~rrrrir/ .ryj x 1N3WSS-aSSV sNOrS•~~iwoV
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THE PROFESSIONALS' PROGRAM AT i I IE INSJ I-1 UTF Of- l IVING Mental Health Care for Professionals The Professionals' Program at The Institute of Living is unique in that it allows people in leadership positions to be evaluated and/or treated with their peers for emotional, psychiatric, and chemical dependency issues. Treatment is designed to improve interpersonal relationships, work performance; and overall functioning. The program provides opportunities for the clergy, business executives, doctors, women and men religious, nurses, social workers, pharmacists, lawyers, judges, teachers, and other professionals to obtain treatment with fellow patients and staff members who understand the concerns they face. Problems addressed in the Professionals' Program: • depression • alcoholism • bipolar disorder • co-dependency • sexual disorders • sexual abuse issues • gender issues • stress management • burnout • drug dependence • excessive anxiety • personality disorders • bereavement • assertiveness • marital/family issues '~ PUINIIFFS DEPOSITION '~ ODIIIlIT • licensure and legal issues Treatment settings available in the Professionals' Program: • The Professionals' Day Treatment Center Monday-Friday, 9:00 A.M. to 3:00 P.M. • Outpatient • Inpatient • Residential • Aftercare Treatment Following a case management model, patients continue to see their own individual psycho- therapists, or develop a therapeutic relationship with one of The Institute of Living's specialists. In the Day Treatment Center, treatment is largely based on group psychotherapy. Living arrangements Patients have the following options, based on clinical needs: • Supervised living in nearby Institute of Living residential programs • Independent living in the community, located with assistance from the Professionals' Program • St. Thomas Seminary for clergy For further information For additional information on the Professionals' Program, including fees, call Program Director Heidi McCloskey, R.N., M.S.N., C.S., at (203) 241-8061. For referrals, call the Patient Services Office at (203) 241-6900, or (800) 673-2411. r 19 111114L•.411 THE INSTITUTE OF LIVING 400 Washington Street • Hartford, Conn.oticut 06106 Hartford Hospital's Mental Health Network
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The Institute of Living > fitunclccl in 1822, is ,t nctt-liw-Itrctlit, c cn»l~rchc nsivc ccntcr fcrr tltc cvalttatiotl, trcat , anci foIlow-up care of psycltialric, c•nu.rticrnal, and addiction clisctrclrrs. Once known alrnerst ec(--lusivelyas a Itosl)ital, '1'Ite lnstittttc nenwctfTi:rs a hroa(l til)ectr-um erf*scrvic-cs art(l prrogranis that increasingly fcrcus on ctutltaticn't care. A4crst patients can ccrntinue tcr live at ltonrc or in tltc nearby ccrmtttunity during treatment, attcl I)ru};rams can bc t<tilc>rccl tc> rttatch their inciiviclual neccls. As thc science ctf psyc.hialry has advanced ancl changecl, 7'hc lnstittttc has clt;ui;;c•c1 with it. 'l'rcattncnt today tcncls to he Itricl'ancl nutrc gct;tl-crricrntccl. Scic•nlilic lrrcaktluruu};Its ill Ic•cltnc~lo};yanci Irltartnaculcgy Itavc grc•ally intlrrm-rcl clia};uusis ancl crtttccrutc. Nu longer utust .citnc• Irttic•nt` slrc•ncl nurntlts Ur cvc•ti ti,c•ars ill the Itusltital... crr };ivc• ul> a<•:rcc•r... crr Itolrc titr ncrllting Ix•ymncl a.>ntpasic,tutlc CarC. Patients are rcfcrrecl intct'l•Itc lnstitutc•'s systctn ctt carc Irurrt a v.uriety crt'sutn,ccs, incltulittl; ntctttai Itcaltlt Itrolcs,icttt;tls ill Irrivatc• Itractic•.e; hospital eruc•rp-ncy rc>ctnts: c>ur utvn (:crnsttllatictn Scr%licc•; self rcCerrals; and wltcr instituti<tnx ancl inclivicluals in tltc• region. Witlt <nu. "cxrntinnuttt ctf'carc•,":t patirnt can cntcr at Ilte nrutit <tltlrrctltriatc Ircrinl ancl Irrcil;n•xx al thc• utcost c littiralll' c Ii'c ctivc ratc•, or, tuulc•r Ihc• l;tticlauce crf a L>t ivalc clinician, sintltly ttuakc• utir c>f Ih()sc sc t~ricc•.ti Iltat :urc• nc c~clc cl. Tli[_ INS'Tll'IJ1'k'S GROUP'L'!S, l/•1.(1 SC.AYF.I'i [3Y Fuk DC.:NIC:M. L..A'N e), M1i1L 1) HNl) GRaCr Il'w, lli •:i,:.Ii.r.ur. i•,u.,e'n.1i AcAi.nar:, i.in.[. [ •,:.. 6989 OLLiS ®
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k WIM 5989 OLLiS ;THE INS'CXTUTFy`OE, LIVIRG M Mlrww%~'x t 1i: 11 i4:A;{?•f l •S~xtcno of Carf~ s r i ~ PIAINTIFF'S DEPpSIj~p ~ EXHI9IT 0 ~ tJ~s'1t~c ~.Z a a e W , h
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. EATING DISORDERS PROGRAM AT THE INSTITUTE OF LIVING L PHILOSOPHY Anorexia nervosa, bulimia nervosa and related eating disorders are serious, potentially life- threatening problems that affect increasing numbers of people of all ages. Early identification and comprehensive treatment increase the possibility of recovery and health restoration, and minimize the suffering of those afflicted and their families. The Institute of Living offers a specialized program for the treatment of eating disorders in children, adolescents, and adults. We provide a continuum of care that includes outpatient, day hospital and inpatient services. Residential and consultation services are also available. The initial assessment is provided by an eating disorder specialist. Treatment recommendations are geared toward the individual needs of the patient, to provide comprehensive treatment in the least restrictive environment possible. Treatment is provided by a dedicated interdisciplinary team of eating disorder specialists in the fields of psychiatry, psychology, nutritional science, dance therapy, nursing, and social work. HOURS Partial Hospitaiization Day Program Monday-Friday, Braceland 1 ............... 8:00 a.m. to 4:00 p.m. Evening Program Wednesday and Thursday, Braceland 1 ...... 3:30 p.m. to 8:00 p.m. Other outpatient services are scheduled Individuaily FREE SUPPORT GROUPS F.E.E.D. (Families/Friends Education for Eating Disorders) Thursdays, Staunton Williams Building ....... 6:00 p.m. to 7:00 p.m. Patient Support Groups Call the Eating Disorders Program for information ... (860) 545-7203 REFERRALS Patients may refer themselves, or they may be referred by health care professionals, schools, friends, or family members. For an initial assessment, please call: ASSESSMENT CENTER, (860) 545-7200, or (800) 673-2411 For additional information about the program and services, please call: MARGO MAINE, Ph.D., PROGRAM DIRECTOR, (860) 545-7203 OR ROBERT J. WEINSTEIN, Ph.D., PROGRAM MANAGER, (860) 545-7203 b ~ rLANliM OEPOSRION Exilmlf ~ THE INSTITUTE OF LIVING 400 Washington Street • Hartford, Connecticut 06106 Hartford Hospital's Mental Health Network Ln ~ J J m m co co co a:EltTasFS.ooo 1aSe
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RESIDENTIAL SERVICES I. Residential services - either supervised apartments or group homes - are effective alternatives to inpatient care that support individuals in the least restrictive setting possible. Offering safe, structured housing to people who are experiencing psychiatric or emotional difficulties, Residential Services at The Institute of Living also provides therapeutic programs and access to additional programming at The Institute or elsewhere in the community. The Community Integration Program offers home-based services to people with learning disabilities and behavioral or emotional problems who require additional support to live independently in the community. Director of Residential Services - Edward B. French, ACSW, CISW - 241-8036 THE BUCKINGHAM, ON GROUNDS - Group home model for long- or short-term caenrs Program Manager - Peter Adelsberger, M.A. - 241-8059 • 24-hour on-site staff • Individual counseling • Supervision of medication • Recreational outings • Assistance in applying for benefits • Coordination with other programs and care providers • Discharge planning, including assistance in finding housing, treatment programs, and educational and vocational resources • Teaching and supervision of daily living skills, including social and interpersonal skills THE BARNARD - Supervised apartment model for independent adults. professionals Program Manager - Renee Leone, M.A. - 241-8052 .4 clergy • 24-hour on-site staff availability • Program development based on individual needs • Life management skills training • Interpersonal skills development MAPLE AVENUE APARTMENT PROGRAM - Program Manager - Lorraine Gardner, M.A. - 241-8090 • 24-hour on-site staff • Training in daily living skills • Life management skills training • Interpersonal skills development • e • Individual counseling • Treatment coordination • Relapse prevention • Recreation/leisure activities W PLAINTDFPS DEPOSRION EXNIBIT Supervised apartment model for young adults Relapse prevention Referral, advocacy and linkage services with community resources Assistance in moving to more independent living situations COMMUNITY INTEGRATION PROGRAiVi - Home-based community services for Program Manager - Marie Patterson, MSW, CISW - 241-8000, ext. 6300 individuals and `amilies • Ongoing assessment and monitoring of an individual's needs + strengths • Individualized service plans • Support, guidance and training in accessmg community resources, including advocacy for the client • Safe and trusting relationship • Assistance in identifying symptoms and learning coping skills • Daily living skills training • Training and counseling in developing interpersonal, vocational + leisure skills • Available after-hours emergency response by phone • Family education and intervention ` THE INSTITUTE OF LIVING Hartford Hospital's Mental Health Network s 400 Washington Street • Hartford, Connecticut 06106 R ^ . -- )w
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STATEMENT OF INTENT This guideline is not intended to be construed or to serve as a standard ut. medical care. Standards of medical care are determined on the basis of all clinical data available for an individual case and are suhjrct to chan~e a: scientific knowled,e and technolop• advance and patterns evolve. These parameters of practice should be considered guidelines only. Adherence to them will nor ensure a successful outcome in every case. nor should the%• be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate jud,-Iment regarding a particular clinical procedure or treatment plan must he made by the psychiatrist on the basis of the clinical data presented hv the patient and the dia;nostic and treatment options available in the par- ticular clinical setting. This practice guideline has been developed by psychiatrists who arc in active clinical practice. In addition, some contributors are primarily in- volved in research or other academic endeavors. It is possible that through such activities some contributors have received income related to treat- ments discussed in this guideline. A number of mechanisms are in place to minimize the potential for producing biased recommendations due to conflicts of interest. The guideline has been extensively reviewed hv mem- hers of APA as well as b% ~epresentatives from related fields. Contributors and reviewers have all been asked to base their recommendations on an objective evalyation of the available evidence. Any contributor or re- viewer who has a potential conflict of interest that may bias (or appear to bias) his or her work has been asked to notifv the APA Office of Research. This potential bias is then discussed with the work group chair and the chair of the Steering Committee on Practice Guidelines. Further action depends on the assessment of the potential bias. This practice guideline was approved in •)uly 1996 and was published in October 1996.
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»t t 1 1 IF AN1 I :IZI(:;\N JOF IIATIZY, \,1',, ~, .i ii 1'., , lii , i.iI it I!
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GERIATRIC PROGRAMS AT THE INSTITUTE OF LIVING MENTAL HEALTH CARE FOR THE OLDER ADULT PHILOSOPHY Geropsychiatry is a specialized area of knowledge and expertise, focusing on the physical and mental changes af aging, the specific needs and tasks of older adults, and the issues of loss and adjustment of lifestyle that accompany the a9ing process. People who benefit from geriatric services generally belong to a specific age grou . They often are experiencing or struggling with changes brought on by this phase of life. PROBLEMS ADDRESSED IN THE GERIATRIC SERVICE • Anxiety disorders • Medical/behavioral • Bereavement • Differential diagnosis + Depression • Chemical dependency 0 Somatization disorders • Adjustment disorders related to physical • All psychiatric diagnoses or lifestyle changes, or dementia TREATMENT SETTINGS Treatment may be provided in a variety of ways across a complete spectrum of care including: • Outpatient settings in Hartford and Farmington + • Consultation to individuals and families • Collaboration with community clinicians and facilities • Day treatment programs in Hartford and Farmington • Dedicated inpatient unit with spcialty programs • Home visits and home care TREATMENT Treatment begins with a specialized and comprehensive assessment and a resulting plan of care. Treatment may include individual therapy or counseling, grou~ therapy, fami'y or marital therapy, monitoring of physical symptoms, medications, psychoeducation and/or case management. All programs include a focus on chan igng physical needs, the interaction o mind and body, issues of coping with loss, the changing need for physical and social supports, and the impact of all these changes on self-image, family roles and coping. INFORMATION - For additional information or to make a referral, call: The Institute of Living Assessment Center Eugene Hickey, LCSW 7 Days a week, 24 hours a day Program Director, Geriatrics (800) 673-2411 (860) 545-7184 ~ THE INSTITUTE OF LIVING 400 Washington Street • Hartford, Connscticut 06106 Hartford Hosprtal's Mental Health Netuwork ~ ouofloM Ln ~ -J J m ~ ~ ~ ~ I di*.rocr,r,een n:Q9r1focr.aoc 12-96
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SPECIALTY PROGRAMS IN A VARIETY OF' AREAS MAKE THE INSTITUTE A VAL_UAHLE RESOURCE FOR THE COMMUNITY. AND THE COUNTRY. 1?eltteatiun:,l I,reigr:ttns at l'hc• Irtstilute• Ite•Ilt te, elisu•niin:ttc• re•se'arrlt Ius,tlt..-:ts well as ittli,rntatie,n };uiuc•el lie,tn e•xltcrirne-c-tu lre,tlt Ituhlie anel lttoli•ssiun:tl :IEUIie•ne e'ti. '1 Ite• Instilute funcliuns as a c<,mutunity resutu'cc' ill (,lirring insight anel knuwkxlge, ufltrn frer of cL:uge, tu sclu,e,1 anel ( Iltu rh l;ruups, civic urganir.atious, prufi•ssional lruclic•s, .utd thc• 1>Ultlic at large. National prufcssional gr<iults };atlter al 'I'lue Iustitutr annually to review the latcsl linclings in Ihrir licrl(1s, whilc• Institutc spcakcrs:ue av:tilablc ur any url;anir:ttiun scc•king infitrmatiem. Irt aclditiem,'I'hr lustinttc func•tiunx as :t I>re,fi•ssic,nal uainiup{ certtcr lur ItxycLiau•ists, lrxyclwktl;ists, suc•ial wurkct:e, nw se lheral>ists, rehabilitatiem spce ialists, arncl uthc•r prufirssic,nals. 'I'hroul;h utn- afiiliatiun with tltc Universitv of (:uunectievt I Iealth (:enlcrr, •I'he Instittttc• of I.ivingi'UnivcIrsity ed'(:unnecticvt rlinieal 1'Sye7hiatric ILr.iel< u< ,v 1'rc,grant c,lli•rs an uutst:uulirng c:ducatiun pn,gram, anel an exceIlent cliuical, biulu};ical, Ix•havi<,ral, anel sueial-u ic•ne c• mse:u•ch Irre,};ratu. SPECIALTY PR()GR:1'11ti ~r In.rliH~lr eif Lii•in;; has :tltl:u trO xume• erf Iltr rcernnlty's roust cxlrcric-nec•cl and knutslrell;cable slu•ci:tlists in a widc• varic•ty crf liclcls. 1':niunls bc•nc-lit ne>I unly frum tlte c•ctntittuum (tf c:nre de."wrileel alwve, Ixtt alse, Ire>nt ae-crss to e linicians wlw arrc expet•ienccd in ttraling Iltrir sl,ecif ic furm of illnrss. ® Sl,ct'i:tltt' I,rugt:tnts :u 'fl ir Instiunc c,1 I.iving in( Iuelc•: Adult Day Treatment Center I':u-tial hospital I trci};rant Center for Couples and Families (::unpleti theral)>, (:roup thcraliy lirr cutyplrs Fantily therapy 1)ivurce cuunselinl; Chemical Dependency Service lulr,ttieut (,r oullrUirnl cIetuxilic'atiun Iluc };rxlccl inltatic•nt ptu};rant I):ry h c•vrninl; Iru tial Itexpital pn,};rams Afterc:re Rclal>%c Irrevc-ntiem Familv progr:nn/Ade>lrscenl progr•atn Child and Adolescent Psychiatry Adulese:ent itipatient setvices P:u tial I luspitalizatiun A<lulescent Setvice (1't IASN) (:hildren's 1)a), I luspit:tl C;hildren's Ncturopsychiatrir I)ial;nersis Prugt atn 9L89 OLLtS :~.
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Practice Guideline for the Treatment of Patients With Nicotine Dependence American Psychiatric Association i. I\7RODUCTIOti This practice guideline provides guidance on the care of patients with nicotine dependence. Cigarette use is the most common cause of nicotine dependence, and almost all of the data available are derived from studies of cigarette users; thus, this document will focus on cigarette smoking. The recommendations in the guide- line generally apply to all smokers even though noc all smokers meet DS.`4-IV criteria for nicotine dependence (1). This is because most of the principles for treating nicotine dependence apply to non-nicotine-dependent smokers as well. Many smokers have comorbidpsychi- atric conditions (2), which are not described in this guideline; thus, the psychiatrist caring for a patient who smokes should consider, but not be limited to, the treat- ments recommended in this practice guideline. This guideline is intended for psychiatrists. However, the data summarized in this guideline should be useful to all clinicians caring for nicotine-dependent patients. This guideline focuses on three groups of smokers likely to be seen by psychiatrists (table 1). Concurrent with the development of the present guideline, the Agency for Health Care Policy Research (AHCPR) developed its Clinical Practice Guideline on Smoking Cessation (3). The AHCPR guideline focuses on primary care providers but also includes recommen- dations for smoking cessation specialists and health care administrators. The present guideline builds up- on the AHCPR guideline by focusing on specific pop- ulations (table 1) not covered iq the AHCPR guide- lines. In addition, the APA guideline complements the AHCPR guideline in providing detail on the more in- tensive therapies. Psychiatrists interested in providing smoking cessation treatments should be familiar with the AHCPR guidelines (3). This practice guideline is limited to recommenda- tions for treatment. Actions to change public policy to- ward tobacco are very important to decreasing the preva- lence of smoking and psychiatrists are strongly urged to support such actions. APA's Position Statement on Nicotine Dependence (4) lists the more important ac- tions needed. These include: a) encouraging appropri- ate diagnosis and treatment of nicotine dependence as a comorbid condition with other psychiatric disorders; b) increasing state and federal taxes on tobacco prod- ucts and applying the proceeds of such taxes to the pre- vention, treatment, and research of nicotine dependence; c) changing the warning labels on tobacco products to TABLE 1. Target Populations I. Patients who smoke anJ arc hin_ .ren m a p.v;nma:n•, n,t a psy;hiarrt; disorder other than m;onnc dcPrnden:c or withdrawal 2. Smokers who have failyd initial trearment, tur cmalmc cessation and need more tntensive trr.ttment thar:uulJ hr provided by a ps}•chiatnst 3. Psychtatrt; pattents who smoke anJ arr trmruard% ;antincJ to smoke-free tnpatient .rarJ>. re.idrntnal ta;dmr>. rt;. include the high likelihood of developing dependence on nicotine: and d) advocating for health insurance cov- erage of treatment of nicotine dependence M• qualified health professionals. Prevention and treatment of smoking in young per- sons are also very important. This guideline focuses on adults. Modifications for treating adolescents are brieflv discussed in section N'.C.2. Psvchiatrists are re- ferred to Preventing Tobaccn Use Among Yomig Peo- ple: A Report of the Surgeon Gcncral (.5) for more in- formation on preventing and treating adolescent smoking. ii. DEVELOP\IENT PROCESS This practice guideline was developed under the aus- pices of the Steering Committee on Practice Guidelines. The process is detailed in a document available from the APA Office of Research, the "APA Practice Guideline Development Process." Key features of the process in- cluded: • initial drafting by a work group that included psy- chiatrists with clinical and research expertise in nicotine dependence; • a comprehensive literature review (description fol- lows); • the production of multiple drafts with widespread review, in which 23 organizations and over 76 indi- viduals submitted comments (see section VIl); • approval by the APA Assembly and Board of Trustees; • planned revisions at 3- to 5-year intervals. A computerized search of the relevant literature from MEDLINE and PsycLIT databases for all years available (i.e., 1966-1995 and 1974-1995, respec- tively) was conducted using the terms "cigarettes," "nicotine," "smoking," and "tobacco." No exclusion criteria were used. This search produced 675 relevant Am J Psychiatry 153:10, October 1996 Supplement 1 51770 6892
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AFTERCARE AND CASE MANAGEMENT WGrn iI liulitvrl lt•avt•.v TItc• lnailtttc's.saa<•tn uf<:uc•, a ncw pltasc ul lre :Utucnt Ix•gittz. 'I'u 1t<•Ili ltrtw<•nl rc•I:yrsc, RESE:IRCH A\1) EUlC:1T1ON :tntf, tvltt•tt :tltltntltri:tt<•, tu nu1nitur tli<• <•IIi•rtit<•n<•xs 4<I tuc<fic:ttiun as wcll sts trc•auut•til, il is <tlic•n itnportanl 1o tu:tint:tiu cuutact witlt lurtnt•r Iruicttls:ts Iltc•y rc•-c•ntct' Ilte• cunttuttnilly :u large. l)i.c.ltars;r platutin}; bc•};ins wlicn a patient cntt•rs Iltt• systctn. R('f'Crrinl; clinici:tns:u-c• k<•pt :tl)rc:t.t oCthrir palicnls' firo};n•ss, ancl rt•suntc U'e•:utrtcnt tvht•n tltt•.tie liaticnts are• te•Ittrnrcl Iu Ilu•it e:uc t,l)ott <lisch:ul;c. OIItCr Iruicnls ut:tY Ix rcti•t'r<•<1 t<t'1'It<• (nstitutc's uulpalicnl servit•e (4) Ix• Irt•:ttt•cl <tu an oc c:tsi<tttal Ittu ongoing basis after being tli.ch:u,t;c<I, ittxtu in}; a c<mtitutilV uf c:ur.' Casc nt:uta};crs, wlut u ltt•clttlt• tisits tu lirrtucr Ir.ttient, ill Iltrir ltotuvs, arc anuthcr ul) Ii<tn tier :tftc rc:uc•. Fin:tlly, ut:utNftatic•nts arc c-cmt:tclccl at rcgttlar ittt<•tvals In ITltunt• tu It<• ct•rlain th:u tlu•y :ur prugressing uunuallv :tucl tlt:u :t11 is ts'e•11. W Gilt• nul de fint'd n.s a sct.'ic<• <cr prugrant <eflcvcd to ectu' ltatit•nl., rr.c:urlt :ut<I Cclttcatiun at'lltr Inailutc of l.king :ut• nt•t-e•rlltclc..e til:tl :tntl iu1<•gral e•It•ntcuts <tf th<• (utnltl<•I<• xysIctu of e:ue•. 'I'Itruttgh re•suarclt we• c:tlt Itetlx, tu It•ant nt<trt• :tltctttl c'<mtf)lt.x clisurtlc•t's, Iltt•rclry Itt•Iliint; tu <Iis1Tt•I tltc ntytlts tlt:tt It:tw I;tcta•n ult iuuttn<1 thc•tu. 'I'hruuy,lt t•<lue:ttiern ttr c•an lutlx• Iec shvt• cetu nt•tt ktunvle•ell;t• tv itlt tlte 1t(Iblic artti <Nltc•r Itruli,ssiunals. 'I'hr Itt.titutc is :tclit't•I% ' rngagc•cl itt resc:urh in tariuus :ut•a, of ITS)rhiauy. I'Itt• l4raccL•uul Ccutcr fitr Alcntal I lc•altlt atut :1};ing, Mticlt r<mtlucts rc•sr:u•cIT urt thc• tnusl c•Ili-cliw an<I1 t•tltic'al fi),ntx ul Iu ;tlllt el<•IiVc•tv.~ut•tn.1<a tltc t•lelt•rl1', is unc nul:tlTlt• rsatul,It•. titutlit•s of .uiridt•, sc'Itii0I)lui•ni:t, ancl tltc Itr:tirt'S rlt•<v i(:tl a< lkily :tls<t 1Tru%i<le• uur eliuici:uts vOllt vilal inlia'ntaliuu tltat intl)r<t4't•.r• Itullt tlia};ttu.tiis:utd trc•ctltucnt. Anutltcr ttlic of rt a arclt Itt•inl; cuncluctect at 7'Itc Ittstiltutc• rc~ttc< rns uttteutut• .tuelics :uttl tlte• c<ttnltutrrizatiun of u.e•ful clittical tl:tta. In :t tuticfu<• .y.It•ut clcNt•I<tltctf 1» Institutr tt•sc•:trc hrt:e, ris6:ttljua<•<I IrUic•n1 c l:ts.tiilicaliun. ar< let•ing ttsr<1 140 1tr<•<lit l IlIc oul<cmu• <1f Itc:etturnl :tncl rti<mitui 4.14 I.c•ly' Iltc• t Ili<at'r uft:tn•. I':ui<•ttts:u<• strt've•tir<I at fix<•tl ittle•nals tu litu% itIc• tt. ttillt <I,tnt IIcu tti•ill alli•ct tltc twy Itxyclti:ttrq is I It:U I it <•<I. Q SL89 0LLT5
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THE WOMEN'S CONNECTION AT P-fE INS1I1 km tE OF HVING The Institute of Living's coordinated system of services for women seeks to prevent life cycle issues from becoming mental health problems. Highly skilled female personnel. who recognize the special needs of women, offer ccunseiing, therapy and consultation in a compassionate.. supportive manner. Women accessing any part of the comprehensive system can cenefit from The Institute*s full range of services. including programs for substance abuse. geriatrics, and general psychiatry. =,_-~r aoci:icrai information on anv asoect --f °rHS' %!/OINEJV'S CONP1E'CT1ON AT T}HE JNST1TUTE OF LJ1JlNG, please call (8EC) 511_~-7000 or and ask for ---E 'NOMEN'S CNI`lE,:,-iCN.. ~ PLAINTIFP S OEPOSITION BR Avaiiable Ser•/ic es \ i ~:emale theraoists =xpertlse in women s 'ss.=:z Deve!opmentai issues Se rual issues 'vlaicr -onferences ';lin: vcrKsnoos Scec:aiized Soeaxers cure :E ; anc :utoring crog-am _Jeer~ential 'eam 3. iic:ng a- s :4cr:sn.c^s Couples and Family Tnerapy Relationshio issues Career/work-reiatea --ress..,es Parenting issues L:fe cyc!e changes , Group Therapy Sexual abuse survivors grc.c Women's group Eating disorders group ~ =afing Disorders Jar;iai nospital procram - ., ;utoatient program 'ntensive outpatienT progra noatient program - cc-ed :,onsuitation ,utrtional evaluations Jance therapy Sucoort groups ,,-ec m - co-ed . Psychiatric Consultation Ln Diagnosis and treatment • Residentiai Services ~ ~ Affective and anxiety disorcers Sucervised living situations for women ~ Menopause . accessing 10L pro grams m Menstrual cycle m eo Pregnancy tp Pre-menstrual syndrome • 'locational Counseiing orb Assessments Agency contacts • Substance Abuse Follow-up Evaluations Career transitional counseli ng Individual therapy ~ lndividuai Therapy THE INSTITUTE OF LIVING Hartford Hospital's Mental Health .Vetmurk , 400 Washington Street • Hartford, Connecticut 06106 ;ducation ac- ~ 5 ,.....,,..- .,
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A Ir<tlirnt cnrulled in a l,:utial Ituspital u•rvitc• nut% cutne• Io 1'Irr Irt.titrut• as crllcu as x•vcn (Ltys a wc•ck Iu take ]r,u t in a su-uctutrrci 1>ru);raru tltat iucluclc•s aNUri(•ty 0f IIu•r:rltrutic aclieitics. Indiriclualiic(I trcattncttt I)lans :uc• crc•ale•el li,r t•:u h Itaticnt, antl nray incIucir I;ruult, iruiiviclttal, ur f:urnily tltc•rytv, e'lassrs, anei grouli activitics. Partial heesltital laugrants rreluirc :t Itaticnt's Iru ticipatiun fitr fitur (crr ntore) hours it cl:n' to (lualilY for instu-anrc• rciutbtn:.crut•nt. "I'Lc Institu(r maintaitns a);cttc•ral adult Itartial hosltital prergrarn as well as ntore fucuxrtl partial pro};r:uus ill slicri:tlty areas, iucluelin}; (;hcntical I)cltcnele•ncy, (Jtilci aucl At1ule•.rcnl P.yrltiatry, (:cri:uric's, Itttltairccl I'rulessicenals, :tn<1 Eatin}{ I)iserrelt•rx. 1'artial husltital ]tretl;r:utrs arv uftc•u u.u•e1 14) sul)l)lcutcnt t'arc rt•ce~ivcd rlse•wlrcrc; ntarrv IMtic•nts e•nrull in our partial programs while cuntinuinl; ctt srt• their own therapists in the. cuntntttuitt'. OUTPATIENT OalpnlieviJa rome• Iu %Y1e• lri.lilula to ]tarti(•ilr•ct<• in ~arictux inelivitlual :uul I;rceult the•r:tliics. St•ssiuus rrcry Ire st:ItcduIcd un a rt•);ttlar err intcrntittetut Irasis. Au etutpatit•ut utay, lur exauyplu, visit a tltrrapist at a ruitvt•ttien1 titne• lor uut• or tnure scssions a wcck, ur cuntc as inlrc•(lurntly as utu(,c• a uwntlt. Outhatic:nts Irave acccss tu'i'Itt Institutc's Itruad sliecu•uut o[`proli'ssiunal exl)erts in variuUx Wcll-cw);.utiiecld trrattuent approac.hes. Outpatient therapy at 'I'Le Institute tuclay is Irricf, fuc us(•(l, attel };ual-elirrctcel, with tucasuralrk• :tu(l uhjcctivc rc•sults. 71 e:utuCnt m:n illvulve ottly Ihr I)aticnt ur includt ullrt•r I4unily uu•tnbc•rs as well, atul ix gcncraliy lintitc<1 in clttr:uiun. ( htg<ein}; c% :cltr:uietu cttsures that the treatment plan keeps pace with tltc patient's Ixul;rt ss .Ul(l Cv(rlFtltg ItCCCi`. Rlust urcatutent plans inclutle a bttilt-in gual th:t1, i~lrcn reacltc•cl, xi}lnalx tlu• cu<I uf Ilterapy . Patients with tuurr Ix•rsistc•nt Itrceltlt•tus utal' rt•tltuire suutc 1i.tnn uf urauucnt un a cetutiuuinl;. Ir.t.is. 'l'Ituxe• uu nu•eliratiun will usualh' Ix• tnunitutcel liW s<rntc• tirue• ttiitlt ur witlurul tUncuntitant tlrural»'. EL89 OLLTS 6
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American Ps1'cblatYlc Association Practice Guidelines Practice Guideline for the Treatment of Patients With Nicotine Dependence WORK GROUP ON NICOTINE DEPENDENCE John R. Hughes. M.D.. Chair Susan Fiesrer. \I.D. Michael Goldstein. M.D. \Iichael Resnick, \1.D. Nicholas Ru:k. \l.n. Douglas Ziedonis. M.D. STEERING COMMITTEE ON PRACTICE GUIDELINES John S. \lcinq•re, \I.D.. Chair Sara C. Charles. \1.D., Vice-Chair Deborah A. Zarin, \1.D.. Director. Practice Guideline Prolzram Harold Alan Pin.us, \I.D., Director. Office of Research Kenneth Z. alrshuler. M.D. William H. Acres, M.D. Thomas Bittker, M.D. Barton Blinder, M.D. Paula J. Cla.•ron, \1.D. lan Cook, M.D. Leah Dickstein. M.D. Helen Egger. M.D. Gerald Flamm. M.D. Steven Jaffe. \1.l). Sheldon Miller. M.D. Louis Alan Moench, M.D. Roger 1'eele. M.D. Bruce Pharssis, M.D. Joel Yager. N1.D. CONSULTANTS AND LIAISONS Grayson Norquist, M.D. (Consultant) Richard Kent Harding, M.D. ( Consultant ) Justine Kent, M.D. (Liaison) John Oldham, ,ti1.D. (Liaison) Marcia Goin. M.D. (Liaison) Maria Lymberis, M.D. (Liaison) Marion Goldstein, M.D. (Consultant) Laurie Flynn. M.A. (Liaison) Alfred Herzog, M.D. (Area I) James Nininger. M.D. (Area lI) John Urbaitis, M.D. (Area 111) Philip Margolis, M.D. (Area IV) Allen kavser, M.D. (Area V) Lawrence Lurie, M.D. (Area VI) R. Dale Walker, M.D. (Area VII) Leslie Seigle. Project Manager Developed under the auspices of the Steering Committee on Practice Guidelines. Successive drafts reviewed by APA components and members, as well as other interested individuals and organizations Isee section VIII and two members of the editorial board of The American f wrrnal of Psychiatry. Approved by the APA Board of Trustees in July 1996 and published in October 1996. Received by The American f ourna! o/Psvchiatn• Feb.14,1996; revision received Julv 11,1996; accepted July 18, 1996. Copies of the Practice Guideline for the Treatment of Patients With Ivicotine Dependence (1SBN 0-89042-308-3/ are available from American Psychiatric Press, Inc., 1400 K Street, N.W., Washington DC 20005; telephone 1-800•368•57771order number 2308, 522.501. Copyright @ 1996 American Psychiatric Association.
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Ctl.l+. I N S TC7 Uk;,; 1 l'orir~relteu'srr+r ;Sv Att,ur- + ~ i. ~ ~ ; ltEISk.AN(~1 i Sk.AN(~1i AVl) CsUUCA'!'ION I SPECIALTY PROCRAMS
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THE ADDICTION RECOVERY SERVICE IQ AT THE iNST1TUTE: Of- L IVING a R PHILOSOPHY Chemical dependency s a cisease. It s a:estrUctive crocess characterized ny a prysca! andlor psychoiogicai detiE!'cence upon mecd-aiterina cnemicals. Causal fac:ors inciude biological risk. seciaucr ra.. erv ronmentai infiuer;es. csychological influences. and :he adaiction ootentiai cf mir,'c a,.erir.g chemicais. cependency is multifaccted arc ndividuaiizea in ;s Jrfec:. ,;n:ie it can ce .rea.:=u _. .., s:rested. it cannot ce curec. TREATMENT SETT]NGS I 0 , I ea:mPnt -Sses-rer't. _ _ .,.. „..c. , arc _, at~:arcf_'erQ;<IT'CiallOn prccgr am _.., ~ .. 'ncal er',: ~C e?1~2v Cnemica! Jeoercer,ci = __ J ',ice J'a;' ar,d . .eriry .,~.. ;:rarrs . 'ec: ~cwer, - :( ~~s:crra.., ~_,' c. _.,,_..~ ,..;cate .i croarar-^..;^c ^ ~ „ .~ _,. -rarsccrrat ... :--rc :. _..,.: e o•cv EXHIBIT TREATMENT Fmpioying case . anager e. .-cce. ?ecovery Ser,rice rcc•oc ~:as . e ` ilG'Ning OOt!O 1S in' ^fi.iViC._u zc reaim=ri 0'arS. . Indrvidual .nerap_, N, aner:;, ~ c theracy ar^ ~ar^ rc'.. :"erapy :reai C. .GaC.s. :^C -,acS- 3ctfvltcs +',VeeKend ClanninC. .,.," ~ + Fuucational cur.'ICUlum .,, .. c =isease a-,a 'ecC','e."- _ ..,cZ . '2-step orogram jrientarc.- • Continuing care. :wice a .,ee.<. oay or evenino. ~o .: onths a \.CCcSS ?C InStltUi? of ':v'r'^ i_'C°filSe. i^c'UOIn y; ?Tf9„:I~~ e~e :nagement/?reatment u aa ^.IaG! CS,S THE INSTITUTE OF LIVING SYSTE3M OF CARE Because The Institute of L:ving :s a comprenensive system o; -are. patients in the Ad :icticn Recovery Service have access to a:vice variety of services. Reracilita.,on. supervised living `aciiities. an : medication management are ust 4 few of 'ne avaiiac!e .envices designed to move patien;s n•to :he least restrictive and most effec;ive level of care. INFORMATION For additional information or ;o make a referral. call: Paula Ruth, R.N.. C.D.N.S.. Director The Assessment Center Addiction Recovery Service or (860) 545-7200 (860) 545-7070 . (800) 673-2411 THE INSTITUTE OF LIVING 400 Washington Street • Hartford, Connecticut 06106 I Hartl'vrd Ho±pita!'s Mental Health Vetmork ~ PUINTIFF'S DEPOSITION EXHIBIT ~~'~Y~t arz~" VLAINTIFF'S DEPOSITION . . ~.. -••~YfS .. ,.._ ..... ~
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?.ICOTINE DEPENDENCE TABLE 2. DSM-IV Diagnostic Criteria for Substance Dependence and EXampks of Their Applicat,on to Nicotine Depenoence (10' A maiadaprtVe pattern or substance use. ieadmc to cimt:ali.- stentn:ant tmratrmrn: nr ~~.:rr... as manitested bY three tor more. or the tolios-mc. o:curnng at am- nme in rhr samr 1_-mar.tt•. ^crio.:. Criteria Tolerance, as defiaed by either A need tor markedly increased amounts or the substance to achieve intoxication or desired eftect \larkedl.- d:mtnished etteci with continued use or the same amount of the substance' Ex.Inir~c. \lost smokers es:aiatr use to I park•.i.tt r: morr r% aic _14 Absence or nausea. d:zznnrs3.. ct:. Withdrawal, as manifested by either The characteristic withdrawal syndrome ror the substance The substance is taken to relieve or avoid withdrawal s.-mptoms The substance is often taken in larger amounts or over a longer pe- riod than was intended There is persistent desire or unsuccessful effort to cut down sub- stance use A great deal of time is spent in activities necessary to obtain the sub- stance, use the substance or recover from its effeets Important social, occupational or recreational activities are given up or reduced because of substance use The substance use is continued despite knowledge of having a per- siscenc or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance TABLE 3. Items and Scoring for Fagerstrom Test for Nicotine Dependence (11) tobacco, a desire for sweets, increased Questions Answers Points coughing, and impaired performance 1. How soon after you wake up do you smoke your first cigarette? 2. Do you find it difficult to refrain from smoking in Yes places where it is forbidden: e.g.. in church. at the No library, in the cinema, etc.? 1 0 on vigilance tasks may occur (16. 17). Withdrawal symptoms begin within a few hours and peak 24-48 hours after cessation (17). Most symptoms last an average of 4 weeks, but hunger and craving can last 6 months or more (17). Nicotine withdrawal symptoms are due, in large part, to nicotine depriva- 3. Which cigarette would you hate most to give up'r The first one in I tjGn (16, 17). Cessation of smoking can the morning cause slowing on EEG, decreases in cor- ~II others 0 tisol and catecholamine levels, sleep 4. How many cigaretres/day do you smoke3 10 or less 0 EEG changes, and a decline in metabolic 11-20 1 rate (16). The mean heart rate decline is 21-30 2 about 8 beats per minute, and the mean 31 or more 3 weight gain is 2-3 kg (16). Withdrawal S. Do you smoke more frequently during'the first Yes 1 is usually most severe from cigarette ab- hours of waking than during the rest of the day? No 2 stinence compared to other forms of to- 6. Do you smoke if you are so ill that you are in bed Yes most of the day? No 1 0 bacco and nicotine medications (16, 17). As with all withdrawal syndromes, the severity varies among patients (16). Cessation of smoking can produce clinically significant changes in the oxide in tobacco smoke rather than nicotine itself (24, blood levels of several psychiatric medications (table 5) 25). Smoking cessation dramatically reduces the risk of (8). For example, smoking decreases clozapine and heart disease and cancer and prevents continuation of haloperidol levels by 30% (8). This effect appears to be the decline in lung function in those with chronic ob- due, not to nicotine, but rather to the effects of ben- structive lung disease (18). zopyrenes and related compounds on the P450 system. Withdrawal symptoms can also mimic, disguise, or 2. Nicotine withdrawal aggravate the symptoms of other psychiatric disorders or side effects of medications (table 6) (8). For example, The DSM-IV criteria for nicotine withdrawal are listed when an alcoholic smoker who is also nicotine depend- in table 4. In addition to these symptoms, craving for ent is admitted to a smoke-free ward for alcohol detoxi- See tablc i Many smokers light up tmmedtatri% arter i•r:n_ ar• a>n,o.r•trcn• arca Most smokers do not intend to smoke .; %rar> iatc:. he:c in tar:. over -0°e continue to use disease or ulcers and continue to smoke "%o of smokers have tried to stop. S?"" at thcse havt• not hcrn able to stop despite repeated attempts and unlv ot .rlt- quitters are successful Leaving worksite to smoke Not taking a job due to on-tob smoking rrstn:nun. Many smokers have heart dtscasc: chrum: ohstru:ttsr pulnwnar% Within 3 minutes ~ 6-30 minutes = 31-60 minutes 1 After 60 minutes 0 4 Am J Psychiatry 153:10, October 1996 Supplement 51770 6895
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: ~Ii OTIV \111 \k TABLE 7. Strategies of Psychiatric Management for Patients Who Smoke •A>,e„ cmoian_ iVnatinr. mumarinn noaur, mon.atnr, ron and n.trner, u)yutrnn, . Ecrai+itsn .t therareun; alhan:e • AJStcc panent rn at<,p • .a.,ist in x,sancm • .arrar.;: tulio~sc-ur _ain. fear of ~+•ithdra~~•al, and fear of failure (49). As- sessment of motivators and barriers appears helpful in motivating patients and is recommended 11111 (501. Ex- acerhation of psychiatric symptoms is likely an addi- tional barrier for psychiatric patients 139). 4. Smoking histort• Seventy percent of smokers have tried to stop in the past (2-1; thus, the lessons learned and patient percep- tions about these prior attempts need to he assessed 11111. The more important areas to he assessed include the smoker's reasons for quitting, any change in psyehi- atric functioning when he or she tried to stop, cause of relapse le.g., whether the relapse was related to with- drawal s.;mptoms or exacerbation of a psychiatric dis- order), how long he or she remained abstinent, whether he or she sought treatment before, adequacy of prior treatment in terms of dose and duration, compliance with treatment, whether he or she believed treatment helped, and his or her expectations about future treat- ments 11111. S. Psychosocial factors Since social support is a major predictor of cessation (51), the smoking status le.g., never smoked, ex- smoker, current smoker) of others in the household and close friends should be assessed 11111. If others in the household are current smokers, their willingness to quit at the same time as the patient or not to smoke in front of the patient should be determined. Whether and how others in the household and friends have supported or undermined prior quit attempts should be assessed. 6. Patient preferences TABLE 8. Recommended Treatments for Nicotine tkaenoence P.v:n,wWIa.u Tner.ir:r• •. .a: ... ? : . ... . \tuiti:nmrom;nr ivn.mro- \„ .a:. _.... 1 therap% II, S 'i.tli, tr.rmtne rei.rp•r rrr• II ::r. ur rr.ut..... 2t.t wnnun I >tumuiu.:ontrod III kapiJ cmoi.m_ III! >rlt-hrfr matrrtal. III' \i:,,unc _um n„,,:m: :II ( i,~n~,i:n; !II inr in the last - days and ofiera a better mra:urr ot tut.tl daily nicotine exposure 152). Xlea:uremrnt (tt :utrntnt• level has been proposed to help guide nicotine rel+la:r- ment, hut the utility of this strategy Kas nttt been %%rll tested (.i3). Carbon monoxide level is usualiv mea.irrr.l by breath and reflects smetkin;, only over the la.t tc•" hours c52). The major asset etf carhtm monoxide level is that it is easily measured and can he used to vrnt% cessation when patients are using nicotine replacemrnt (52). Carbon monoxide measurement can he used ttt motivate cessation' or reinktrce ahstinence, hut its rhi- cacy is unclear (5-}). Patients usually are truthful about their smoking status and the number of cigarettes smoked per da% • 155). Thus, although the described measures show promise as helpful assessments, at present they are not necessary for evaluation of smoking cessation. S. Overall psycbiatric/t•crrcral nrcdical cvalir.ttion Psychiatric assessment in smokers places special em- phasis on screening for affective and substance use dis- orders because these disorders are prevalent among smokers and have been shown to interfere with smok- inl; cessation 111 (2, 34). Smokers should also he briefly screened for the signs and symptoms ot most common causes of morbidity and mortality among smokers; i.e., cardiovascular disease, lung cancer, and chronic ob- structive pulmonary disease (20, 21). Among smokeless tethacco, ciFar, and pipe users, mouth and upper airway cancers are the most common causes of tobacco-in- duced mortality, and patients should he screened for their presence (20. 21). Smokers vary in their treatment preferences. Man% • patients have strong likes or dislikes about pharma- cotherapy, group therapy, and individual therapy. pa- tients sometimes prefer to stop smoking on a certain date. These preferences and their basis should be elic- ited and should be considered when developing a treat- ment plan 11111. 7. Nicotine%otinine and carbon monoxide levels Nicotine and cotinine levels can be measured in blood, saliva, and urine (52). Nicotine level can reflect smoking over the last few hours; whereas the level of cotinine, a metabolite of nicotine, is sensitive to smok- D. PSYCHIATRIC: MANAGEMENT In this guideline, psychiatric management refers to the Akills and techniques that are critical to the care of all patients with nicotine dependence (table 7), regard- less of what specific techniques are used (table 8). These techniques are common to all smoking interventions and should he used with all smokers. Meta-analyses have found such techniques to increase quit rates by a factor of 1.5 to 2.0 (3, 56-58). In addition to the pres- .ent guideline, several other descriptive reviews of the skills and techniques critical to smoking interventions have been published (59-67). Am J Psychiatry 153:10, October 1996 Supplernent 51770 6898 7
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\'ICOTI\'E DEPE'.ME-1CE 1. Estabiishing a therapcutic alliarrcc Niconne dependence is a chronic relapsing disorder: e.g., most smokers require 5-7 attempts before they fi- nallv quit for good (27). Man.• patients don't realize it usuall}. takes several attempts to stop smoking. and they will need to be remotivared to attempt to quit after a failure [II) (611. Because of this, it is important to es- tablish a therapeutic relationship such that the patient .viU return to the psychiatrist for subsequent quit at- tempts, if necessarv (61). Advice is best given in a nonjudgmental. empathic. supportive manner [III1 (39. 61). No studies have been conducted to test whether confrontational styles of in- tervenrions used in treating other drug dependencies are useful with smoking. In patients with a present or past psychiatric disorder, it is important to convey the mes- sage that simply having a psychiatric disorder is not a reason not to make a quit attempt (II) (63. 68). 2. The treatment setting Treatment best occurs in a system that encourages cessation (61). The psychiatrist should consider making his or her worksite smoke-free (61, 69). Achieving this on psychiatric inpatient units may be especially impor- tant, as discussed later in section IV.C.3.a. 3. Initial interventions a. Increasing motivation and readiness to change. Smokers who are not ready to stop or are ambivalent about stopping smoking are given motivational ir,terven- tions such as personalized information and feedback on the risks of smoking that are particular to the individual patient [tII] (39). If feelings of demoralization are uncov- ered, they can be addressed by informing the patient that even the most committed smokers make several quit at- tempts before they are finally successful (III). Revisiting smoking cessation at periodic intervals, especially when smoking-related illnesses (e.g., bronchitis) or other special situations (e.g., pregnancy, child with asthma ) occur, can sometimes motivate smokers to consider quitting [Il). Documenting smoking status in the medical record may help to facilitate such follow-up. Smokers may express negative feelings or fears about quitting. Problem solving around these fears appears helpful [III]. Clarification and legitimation of their feel- ings and expressions of support and respect also may be helpful [III). It is useful to explore the smoker's reasons for smoking as well [III]. Smokers who become chroni- cally ambivalent may benefit from encouragement to take small steps toward action, such as reducing the number of cigarettes they smoke or trying to quit for just 24 hours [III]. The psychiatrist supports self-effi- cacy by identifying and praising past behavioral change and encouraging the use of strategies- effective in the past. Finally, and most importantly, no matter what the smoker's level of motivation, direct advice to stop smoking should be given [I]. 8 Srratecicc su:h as tnc»r rnrnrnc*nr.: :.i%; :•,,.: ized in the sta_e:- oi chan,r an,i m„cr.atwn.i ment models. There are oniy a tex% au.iic• % rrnn in_ rn; efficacy oi providing advicr irr :moicin: based on srages of .han,e i-0 % .althuuch mouMat10::a: enhancement therapy aFptar> to be etteai% r tor ai;un,a dependence. its effzcnvene:: with nicotine drprn,irn:c has not been tested. On the other hand,;lin,;al rxprri- ence indicates that these apl+ma;hr, ma- hr u.rtul I lll;. h. Inttial nttcrt•cnttun tirr p.urcrtts it•i~.- tr•t:"• to st, !P. The most widel.• used initial mtrrv rntnont are tn; \a- tional Cancer lnstitute's -i .-1x aratecir• ba:ed on.mui.- ers seen in general medical settirr,s. The l+m;,ram con- sists of four steps. or four .-1. (61 :: • Ask and record smoking status icovered in section III.C. ). • Advise to stop: Clear direct advice to stop smoking is essential. It is best to elicit a personal reason to .mp smoking from the patient. One of the best ways to elicit such reasons is to ask if the patient has thought about stopping before and why he or she was interested in stopping on the most recent occasion. • Assist the patient in addressing cessation: The ps% - chiatrist should elicit a commitment to quit. If a specific quit date is agreed upon, the psychiatrist should offer treatments at that time or immediately before the quit ' date. If the patient is not ready to make a commitment to a quit date, the psychiatrist should plan to readdress smoking at a later date, encourage the patient to recon- sider, and offer to help if the patient changes his or her mind. In addition, the psychiatrist should give written materials focused on either motivating the patient to make a quit attempt or suggesting tips on how to make the cessation attempt successful. •Arrartge follo..•-up: If the patient is attempting smoking cessation, the psychiatrist or the psychiatrist's staff should call or see the patient 1-3 days after the quit date. Waiting 7-10 days after the quit date is usu- ally too long, as many patients relapse in the first few davs after the quit date (13). Brief advice by the physician based on protocols simi- lar to the National Cancer ]nstitute approach typically doubles quit rates from approximately 5% to 10% [1) (3, 56-58, 71, 72). Advice from nonphysicians is also effective (3, 58), and advice from multiple sources is more effective (3. 58). Although not tested, brief advice is probably less successful in those psychiatric patients who have poor self-esteem and a more chaotic social, environmental, and psychologic status. Nevertheless, such brief advice from the psychiatrist and other psy- chiatric personnel (e.g., nurses, social workers) is a rec- ommended treatment because it is a base therapy upon which other therapies can be added as needed (I].. 4. Educating about nicotine dependence and its treatment Many smokers don't realize their smoking may be a form of nicotine dependence (11). Key points to convey to patients include: a) the large majority of smokers try multiple times before they finally quit, but with persist- Am J Psychiatry 153:10, October 1996 Supplement 51770 6899
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NICOTINE DEPENDENCE Ill. TRE.aTME\T PRINCIPLES A\n ALTFRNATIVf.-, A. 1\-fRODI'CTIO\ There are manv similarities between nicotine and other drug dependencies (36, 3-). There are also si;;- nificant differences. For example. although nicotine dependence produces dramatic health prohlems, it usually does not produce significant interprrsonal, fi- nancial. legal, or psychological problems. Thus, the present guidelines will in some respects he similar to and in others different than the Americ.trt Psychiatrir Associatioat Practice Grridclirrc for the Trcatnrcut of Patients :cith Suhstancc Use Disorders: .alcoho1, Co- caine. Opioids (38). The following sections contain data regarding the likely impact of avariety of treatments for patients %%•ho smoke. It is important to note that the hulk of these data are derived from studies of patient groups who are not under psychiatric care. (Exceptions to this are noted.) Expert judgment has been used to determine the applicability of these data to the populations under con- sideration in this guideline. B. GOALS OF TREATMENT Long-term abstinence is the ultimate goal of the treat- ment of nicotine dependence. Initial goals include mov- ing smokers from not contemplating smoking cessa- tion, to contemp.ating cessation, to initiating a quit attempt, to quitting for a short period 1111 (3 91. Whether harm reduction (e.g., switching to low nicotine cwa- rettes or cutting down on the number of cigarettes smoked) is an acceptable goal is debatable because the health benefits from these actions are not well demon- strated, compensatory behaviors occur, and patients mav consider harm reduction as a"safe haven," which will undermine later cessation attempts 1401. Whethcr long-term use of nicotine medication is necessary in some smokers is also debatable (41). Management of withdrawal is an important goal' in and of itself, espe- cially for those on smoke-free wards (8). Nicotine in- toxication is rare; its treatment is not covered here, and the reader is referred to other sources (42). C. ASSESSMENT The patient's current smoking status (e.g., current smoker, ex-smoker, never smoked, number of ciga- rettes/day) needs to he routinely determined. The com- prehensiveness of subsequent assessment is determined by the goals and characteristics of potential interven- tions; i.e., different assessments are necessary to guide the application of brief advice, the intensive treatment of prior treatment failures, or the relief of nicotine with- drawal in an inpatient setting. 1. Rcadiness to chanQc and ntorrz-atrn,r tg , j,ut About 40°0 of current smokers are not considrnn, stopping smoking in tite turesecahic tuture 14:,. The:, patients may he uninformed, demoralized about thei- ahility to change, or defensive and resistant to ch.rn,r Many psychiatric patients are proinahiy in thts l+hasr (33, 44). Another 40°., of current smokers are ambiva- lent about quitting (43). These smokers have ;tven se- rious thought to giving up smuiang but arc not %et ready to commit to quitting. About 20'•„ c,f current smokers are intending to quit smoking in the next tew months (43). Many of these patients have made a quit attempt in the past year or ha%e taken small ste)+c to- ward quitting, such as cutting down on the number cit cigarettes that they smoke. Making disttnctians based on readiness to change is important because, as outlined in section II1.D.3., smokers who are not considering quitting appear to need difterent treatments than those who are ambivalent about stopping or those presentlv interested in stupping. 2. Di.tg,tr,sing, ,ticotiuc ,lrpru,/r,t, c• Quantih•ing a smoker's dr;,rrr of nicotine depend- ence is important hecau.e highly nicotine-del+endent smokers are more likely to nrrd more intensive ther- apy, especially pharmacothrrapy (scc section III.F.i. Table 2 illustrates the nS.\l-I\' criteria for substance dependettcr, with exantple, of how ther apply to ni<<+- tinr dependence I1U). Although the I)SM system has not been formally tested as a mra.urr to guide thera)+y, it does appear to he reliable and m have prospective validitv (43-3-1. The Fagerstrom scale assessments (table 3), widely used in treatment studies, have proven reliability and validity (12, 48). They have been shown to predict suc- cess at stopping smoking and, more importantly, to predict which smokers especially benefit from nicutine gum or nasal spray (see section lI1.F.2.e.). Several other markers of nicotine dependence have been proposed; e.g., number of cigarenes/day, time to first cigarette (an item on the Fagerstrom scale), coti- nine levels, amount of withdrawal on last attempt, and number of unsuccessful quit attempts. Huwever, with the possible exception of time to first cigarette 148). these have yet to be shown to have significant treatment utility. In summary, both the DSM-IV and Fagerstrom scale assessments are recommended JII l. .3. Motivattus far and barriers tu quitting The most common reasons for trying to stop smoking are to improve health and in response to social pressure (49). The most common harriers are fear of weight 6 Am J Psychiatrv 153:1 A, October 1996 Supplement 51770 6897
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\ii 0T:\: \I'F\.? ficanon. his or her,anxten•. depression. dif- TABLE 4. DSM-IV Diagnostic Criteria for Nicotine Wrtnarawa' ticuln- concentratrn„ insomnia. irntahil- tn•. and restlessness could hr due to or 3,- ;ravated hy nicotine withdrawal. Also. al- though uncommon, cessation appears to be able to precipitate a relapse or major depression, bipolar disorder, and alcohol/ dru, problems (2, 26). C. EPIDE\IIOLOGI A\D NATURAL HISTORY D. At present, approximately 50% of the U.S. _ adult population have never smoked. 25 %o are current smokers (48 million), and 25% are ex-smokers (11). Among current smokers, most are cigarette smokers, with fewer than 5°i, using cigars, pipes, or smokeless tobacco (11). The mean number of cigarettes smoked per da}• is about 20. Beni•een 8°o and 15°0 of smokers are occasional or light smokers (<5 cigarettes/ day) (11). The prevalence of smoking has declined dra- maticallr in the U.S.; however, this decline has not been uniform and has abated recently (27). The prevalence of smoking has declined less in those who are younger, fe- male, non-Caucasian, less educated, or poor and those with psychiatric or alcohoVdrug problems (2%1. The median age of initiation of smoking is 15 (5). Psychiatric predictors of initiation of smoking include use and abuse of alcohol and other drugs, attention deficit disorders, and depressive symptoms; however, smoking precedes the normal age at onset for most ps}•- chiatric disorders (2). Twin studies have found that the heritability of smoking is as great as, if not greater than, that for alcoholism (28, 29). Some of the heritability of smoking is shared with and some is independent of that for alcoholism (30). Within a few years of daily smoking, most smokers begin to develop dependence (5). For example. 50°0 of smokers in their twenties meet DSN9 criteria for de- pendence (31). Also, within a few years of daily smok- ing, smokers note withdrawal symptoms upon cessa- tion (5). Among older adult daily smokers, 87% (40 million) are estimated to meet DSM-IV criteria for nico- tine dependence (32). About one-third of adults who smoke make a serious attempt to stop smoking each year (27). Over 90% of these attempts to quit are made without formal treat- ment (27). With self-quitting, 33% of smokers are ab- stinent for 2 days and 3%-S% are abstinent for I year, after which little relapse occurs (13, 14). Most smokers make several quit attempts, so that 50% of smokers eventually quit (27). Smokers with a past or present his- tory of anxiety, depression, or schizophrenia are less likely to stop smoking (2, 8, 33, 34). This could be due to several factors, including increased nicotine with- TABLE S. Effect of Abstinence From Smoking on Blood Levels of Psychiatric Medications (8) :lhsnnrntr In.rea>rx KlrMal I rwl. C•lumrprammr 1)mrpm ll~airl+am Cluzapmr Fiuphrnannc \nrtnpt+imc lkitpramnr HalopcnJul I'rnrram+l„I I)rsmethyIJrazrpam Inuprammc Ahs[[nencr Dc>rs Nor Incrrasr KIuuJ t.cw(. amrtnpt.•Imc kthanr,l \IrJaroaam ChlurJiazetwxiJr Lr+rairpam Tnazulam Ettc.t of Ahsnnencr tm KhH+J t.ctrl,l. L~nacar AIpr.uolam C:hlurprnmarmr htazepam TABLE 6. Some Examples of Nicotine Withdrawal Symptoms That Can Be Confused With Other Psychiatric Conditions (8) drawal or nicotine dependence, less social support, or fewer coping skills (2). Smokers who have current alco- hol abuse/dependence problems are unlikely to stop smoking unless their alcohol problem resolves (34). Whether alcohol/drug abusers in recovery are less likely to stop smoking is unclear (34). About 50°0 of adults who attempt to stop smoking will meet DSM-IV criteria for nicotine withdrawal (17). Smokers who have withdrawal-induced depression or severe craving are less likely to successfully stop smok- ing (2, 17). In addition, fear of weight gain appears to be a major deterrent to cessation attempts, especially among women (35). The presence of cues for smoking is thought to be crucial in producing withdrawal; thus, withdrawal during inpatient stays on smoke-free units is often not as severe as expected (16). (_n N J v t9 ltan•. u.;• „r m:utun: n•- a: cra.: .c,. r.: ., •,,- a~. „: r.a,+ttn: u... , e:....,: . .... •r:. . •.... ., . . . • • r„i:uwrj w:rhrr::4 n„ur, hc r,tr , . •:rr.. . . .... ., ..,,,+:. _ _ . 1• J+<pn„n: ++r J:; r;••r.: m,,,,.: :. m.,annr: r.nwr rir:+. r:u•^an„r, „r ate,r- anmrn, urfn:uir+ :rm:rntrann_ r•• rrair..ne.• -. Jr.rra>rJ hran ratc ~• rn:rra:rJ appanr rr ssrreh: _a:r The.+•mpmm, in Lrnrram F:au.c:inr;:.t rmparrmrn[ rn ++::ut`annnaL „r „rn, ar..r..•r run;n..nnr; Thr scmr[nm, arr n„t Jue u+a erncrai mc.ir:a.:on.r,:n•n ar:.: a:. noc rc^tc: axuunteJ rr+r ht anrxhcr mrnt.tl ar•,a,irr C. tT co Am J Psychiatry 153:10, October 1996 Supplement W 5 m
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\iL kil1\; IlF t'F\;l; \. c b. --lcttpttttcttirc One common rationale tur the use ot acupuncturr tor smukin;, cessation is that acupuneturr can releasr rn- dorphins that assist in cessation. Controlled studies comparing advicrversus sham acupuncture sires do nor consistently show efficacy 13, .i-, 1-', 1-51: thus. this treatment lacks sufficient evidence to he recommended. 9. Dcvrce> Filters have been used to help smokers gradually re- duce the amount of smoking. Short-term studies show smokers compensate for such changes to some extent 19U. 1'91. The few studies of the efficacy of filters are inconclusive (90, 179). A small computer has been de- veloped that uses self-monitoring data to then program a set of times to smoke. The computer gradually elimi- nates cigarettes by increasing the inter-cigarette inter- val. There are no published controlled studies with the device. In summany, there is not sufficient evidence to recommend devices as a treatment. THERaI'1 The goal of combined thc•r,tl+% t• to Pno\ t.ir trr,itat; ;:- fur withdrawal and tc, :on.urrc•nth dc\ clop ann•nt.lk - tn;; skill~. \lust meta-,tnalv>c•• and mu:t. rm`cnntrn:.t trtal., indicate that. unlike other .lrprndc•n:ic•.. tornta: psychosocial treatment t, not r.:rnnal to ohtatn honu.- firs trctm somatic therapies. In other %sur.l•\ ntaittnc rc- placement therapy 0 -1. 5h-5;,. y-'. 113. 124. 1=n. 1'-. 129. 1 ia, l-I6 1 and :IoniJtnr .125. I a.; - tncrc'.t•r .tutt rates hv a factor ut 1.3 to -'.t1, huth when -_t\rn ~~tth brief advice plus tullus% -up ti.r., anular tt, pa:ittatn: management) and w•hrn;,icrn with tormal p:%;hu.u;tal therapy. Although nicotine replacement i% eftrctnr withttut formal psychosocial thrr,tpy, it i. nnportant to nutc• that in most studies, combining ni:uttnc• rrpla:rnient with a behavior therapy gi.•rs suhstantially higher quit rates than either behavior therapy or nt:onnr rc•place•- mrnt alone t3-i, 53. 1'yi. Thus, combined therapy is a recommended treatment I1 l. IV. FORMULATION AND IMPLEMENTATION OF A TREATMENT PLAN A. ADULT PATIENTS WHO ARE BEING SEEN BY PSYCHIATRISTS AND \VHO C:URRE \TLY USE TOBACCO 1. Introductiutr There are only a handful of controlled studies of treating smoking among psychiatric patients (2. '74, 180); thus, much of what is recommended in this sec- tion is based on treating smokers who do not have a current psychiatric disorder plus the general principles of treating psychiatric patients. The guidelines that fol- low are similar to those offered by others for psychiatric patients who smoke (63, 68, 69, 181). 2. Assessment Assessment of psychiatric patients focuses on five points 1111. First, is the patient presently motivated to quit smoking? If not, then motivational strategies should be used. If the smoker is ready to quit, then a concrete discussion of cessation procedures should oc- cur. Second, are there any psychiatric reasons for con- cern about whether this is the best time for cessation; e.g., is the patient about to undergo a new therapy, is the patient presently in crisis, or is there a problem that is so pressing that time is better spent on this problem than on cessation II;II? Third, what is the likelihood that cessation would worsen the nonnicotine psychiatric dis- order Ill ((? ) and can that possibility he diminished with frrqurnt monitorin, , use ot nicotine replacrmrnt thrr- apy, or other therapir.? Fourth, what is the patient's ability to mobilize coping skills to deal with cessation 1111? If coping skills are low•, would the patient benefit from individual or group behavior therapy? Fifth, is the patient highly nicotine-dependent or dors the patient have a history of relapse due to withdrawal sympuoms or increased psychiatric s~•mptoms Ill? If so, which medication might he of help? 3. Psychiatric managc•mcnt a. Increasing readincss/motivatiort. Since it appears that most psychiatric patients are not ready to make a quit attempt (44), most often treatment will consist of enhancing motivation and dealing with anticipated bar- riers to cessation (61). Fears of withdrawal symptoms or of worsening psychiatric problems may he dealt with hy problem solving, increased monitoring by the thera- pist, and behavior therapy or nicotine replacement 11111. b. Stepped care approaches. Since the large majority of smokers quit on their own or with minimal treatment (27,182), most existing algorithms/guidelines rely on a stepped care approach with minimal interventions early on and more intensive interventions for those who are not able to stop with minimal interventions (48, 88, 153, 154). There are three issues to consider with this approach: 1) Most smokers who quit on their own re- Am f Psychiatry 153:10, October 1996 Supplement 51770 6908 1 7
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\I~. 0":\: PE"E\I)E \~ 'r en:e half of all smokers quit: bi the nature isee tahle 4- and duration 4 weeks or ion_er, ot true withdrawal symptoms: ci nrcotrne withdrawal can be relieved with nicotine replacement: and di most smokers tail early on. hur it the smoker is able to remain abstinent for 3 months, relapse is unlikely 11111 i61 i. .i. Tnn„tc of cessation attempt The timingof the cessation attempt is based on the patient's readiness to change isee section III.D.3.b.r and the psychiatrist's evaluation of whether the patient's psychiatric status is sufficienth• stable 1I11) 1681. Thus, cessation ot smoking would likely not be recommended when the patient is exhibiting psychiatric symptoms but could be recommended when symptoms have abated and maintenance psychotherapy or pharmacotherapy is underway 1111 (68). Since smoking cessation can induce withdrawal symptoms that could interfere with psychiatric diagno- sis and treatment and since cessation can change the blood levels of several psychiatric medications Itables 4 and 5) ( 8). it may be best to recommend cessation when no major changes in the treatment of a psychiatric dis- order are underway 11111 (68). If cessation has to he de- layed, the psychiatrist should he sure to keep cessation on the treatment goal list to address at a later time I II. On the other hand, sometimes smoking cessation may be integrated into the lifestyle changes that are a part of certain psychiatric treatment (e.g., during ces- sation of alcohol use) (see section V.A.1.). Also, admis- sion to a smoke-free inpatient unit can be used to mo- tivate a cessation attempt. Finalh•, intervention is indicated if the patient has recently been diagnosed with a smoking-related illness, as smokers with such illnesses generally have higher success rates (49, 73) (see section V.B.I.). 6. .-lhrupt versus gradual cessation \lost patients use and most clinicians recommend abrupt cessation of smoking rather than gradual reduc- tion (74). Gradual reduction has been thought to be less successful because patients appear to have difficulty achieving further reductions once smoking 5-10 ciga- rettes per day (53). On the other hand, most of the sci- entific data available suggest no difference in the out- comes of abrupt versus gradual cessation (3, 53, 56, 75); thus, patient preferences to use gradual reduction should be respected 1III]. However, with a gradual ap- proach, patients should be advised to set a date by which they will completely stop I111I and not to use nicotine replacement therapy until they have stopped using cigarettes III]. 7. Dealing with weight gain concerns One of the most common fears around smoking ces- sation is weight gain (76). On average, smokers weigh 2-3 kg less than persons who have never smoked and when they stor cmokrn, tnec ;ain %ccr_nt unno tn.c .r.. similar in wercht to thu:e wno n; %c•r The larze maiorirv ot smul.rrn gain %c eight m er tnr r:-.- few months post:essatrun. hut mam iatc•r Ir•r o- all of this weight. Women who ar: alrra.i% trvnt_ n• keep weight off gain the most , -- . Even thouch the health henent. cit stul+l+rng-.moicin; clearly outweigh the health n:i;: cit wer:;ht ,.un ,.,~ . fear of weight ;arn is a maror deterrent tu :moi.ing ;c••- sanon, especially amcm-, women °. However. gain after stopping smc,krng .luc•• not cau.c• rriap.c• tt, smoking 1I-;. In fact, concentrated rttcur. to ;onrroi weight gain by dieting during .tl•:nnence rn;re.t•r, nou decrease, relapse hack to smoking i-S. -y:. Thrs niav i•r because trying to stop smoking and trying to diet at the same rime is just too difficult. Rather than Jietrrt~. increasing physical activity upon cessatrun, learning healthy eating strategies, or convincing the smoker to tolerate a moderate amount ot weight gain over the trr.t 3 months and to work on losing weight later on can hr recommended 11111 (80). Nicotine gum, hut nor the nicotine patch. appears to delav-weight gain and could be used to delay attempts to control ts•eight until relap.e to smoking is less likely 11111 (t+1) S. Adt•ising aborrt alcobol.rnd cajjcinc usc Alcohol use is a risk factor in most studies of smoking relapse (82); thus, either diminishing alcohol intake or abstaining from alcohol is recommended J111I. Caffeine use typically does not change with cessation (17), and whether caffeine use is a risk factor for relapse is un- ciear Ib3). Smoking increases the metabolism of cat- feine, and smoking cessation increases caffeine levels by 30';,,-60`%.. (84). Since marn. cif the svmptoms of cat- feine intoxication and nicotine withdrawal overlap (e.g., anxiety, insomnia, restlessness), reducing caffeine intake postcessation might he helpful; however, the one study to cest this hypothesis was negative (84). In addi- tion, abruptly stopping caffeine could induce a with- drawal syndrome of its own (85). In summary, with this contradictory evidence, patient preferences on whether to change caffeine intake should he respected 11111. 9. Follow-up visits The first follow-up should occur within 1-3 days af- ter the quit date, as the majority of smokers relapse in the first few days 11( (13). The scheduling of further follow-ups should be determined by the patient's per- ceived need, past history of cessation, past psychiatric history, whether he or she is taking a medication whose blood level might increase with cessation (table S), and whether he or she is taking antismoking medi- cations that require visits to monitor side effects or plan tapering I1111• At follow-up, the psychiatrist assesses whether the patient has smoked and, if so, the number of cigarettes smoked per day 1111 (61). The psychiatrist also assesses the severity of withdrawal symptoms, the onset of any Am J Psychiatry 153:10, October 1996 Supplement 51770 6 900 9
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~• \ c • . 1rr \•. : "r \ i „ . _. \. i tine tie.'e1s from 1- and 4-mg gum are about one-third ana two-thirds. respecris-elc. of the steady-srate ri.e.i he- tween cr_arettes i levels of nicotine achieved .vith ciga- retie smokinc, (421. Nicotine via cigarettes is absorbed directly into the arterial circulation: thus, arterial levels from smoking are 5-10 times higher than those trom the 2- and 4-mg gums (130). Absorption of nicotine in the buccal mucosa is decreased by an acidic environ- ment: thus, patients should not use beverages ie.g., cof- fee, soda. iuice) immediately before, during, or after nicotine gum use (1301. Nicotine gum (2- and 4-mg doses i has recently been approved as an over-the- counter medication. 2) \icotine patch. The four transdermal formula- tions take advantage of ready absorption of nicotine across the skin (115. 131, 132). Three of the patches are for 24-hour use and one is for 16-hour (waking) use. Starting doses are 21-22 mg/24-hour patch and 15 mg/I 6-hour patch. Patches are applied daily each morn- ing beginning upon cessation of smoking. Nicotine via parches is slowly absorbed so that on the first day ve- nous nicotine levels peak 6-10 hours after administra- tion. Thereafter, nicotine levels remain fairly steady with a decline from peak to trough of 25°o to 40 % .vith 24-hour patches (131). Nicotine levels obtained with the use of patches are typically half those obtained by smoking (131). After 4-6 weeks patients are usually tapered to a middle dose (e.g.. 14 mg/34 hours or 10 mg/16 hours) and then again in 2-4 weeks to the lowest dose (7 mg/34 hours or 5 mg/16 hours). Ivfost, hut not all, studies in- dicate abrupt cessation of the use of patches often causes no significant withdrawal: thus, tapering may not he necessary (133). The recommended total duration of treatment is usually 6-12 weeks (11S, 133). Two nico- tine patches are now available over the counter. The treatment schedule for one of these patches is now 6 weeks only with no tapering. 3) Nicotine nasal spray. Nicotine nasal spray is a nicotine solution in a nasal spray bottle similar to those used with antihistamines (133-135). This treatment is likelv to be marketed in the United States in 1996. Nasal sprays produce droplets that average about I mg per administration. This formulation produces a more rapid rise in nicotine levels than does nicotine gum; the rise in nicotine levels produced by nicotine spray falls between those produced by nicotine gum and cigarettes. Peak nicotine levels occur within 10 minutes, and ve- nous nicotine levels are about two-thirds those of be- tween-cigarette levels (136). Smokers are to use the product ad-lib up to 30 times/day for 12 weeks, includ- ing a tapering period. 4) Nicotine inhalers. These are plugs of nicotine placed inside hollow cigarette-like rods. The plugs pro- duce a nicotine vapor when warm air is passed through them (137-139). Absorption from nicotine inhaler is primarily buccal rather than respiratory (140). More recent versions of inhalers produce venous nicotine lev- els that rise more quickly than with nicotine gum but less quickly than with nicotine nasal spray, with nico- tine blood le% rl, c,t .ti~ou: ci_arette levtl> , IJ, 1. Th; mn.tir r r• ;, • i•c ahout 1= week,. 5~ Othcr ,ucournt• dc•ir:•t•n ences fcu huaal ah>urr+ncm arr.tsaiiahic rn .,mic•;0;:r- tries. hut not in the United State.,. G, Lohclmc. Lobelinr i: a ncmnoha::,, .1ru: ri;.ir shares tcilerancc• with nicotine on .c•%c•ra: mc.t•urc- (1-1? ;. It has been in;ltrdc•d in .c•c rral o% ~ r-thc' :~~llttt~- antismokin; mrdicatnc,n>. Th, I+har ma:r,l.rnc•tn;, o: lobeline in hum in: has not been reported. c. E1'jicac~• 1) \uc,tinc• tt•ithdr.tu•.t!. \i;otinr rrri.t,emc•nt therapy is often used solely hor the l+urpo.r cit relieving withdrawal symptoms in autpanrnt or inl+anrnt .rt- tings. \tany studies have shown nicotine replacement therapy decreases withdrawal sc-mrtum: in outpatient settings (16. 1-). Anxiets-, angerrirnt,ihi lits,.lc prc•:su,n. difficulty concentrating, and impatience arc• u•ually rc•- lieved by nicotine replacemrnt: whc•rra% in:unmi,i :tn.i .veight gain are not consistently decreased 116. I-(. This is true for nicotine gum, patch. spray, and inhaler. NiceW- tine gum appears to he more likelv to delay weight gain than nicotine patch (101 ). Nicotine gum at 2-mg ad-lih appears less likely to reduce craving than nicotine patch or nasal spray; however, this may he a dose-related is- sue, as the -1-m}; dose appears to better reduce craving (143). Whether nicotine gum, patch, nasal spray, or in- haler is better at relieving withdrawal is unknown. Higher doses of nicotine replacement therapy only mar- ginally decrease withdrawal symptoms (101). Whether nicotine inhaler or Ioheline decreases withdrawal symp- toms is unclear (13l+, 144). 2) Lc„tp-tcrnr ahstiur,icc tritl+ .tdjtrnctivc psv- cbusc,cial therapy. Eleven mrta-analyses of over 50 studies that included a psychosocial therapy (usually be- havior therapy) along with nicotine replacement all con- clude that nicotine gum and nicotine patch increase long-term quit rates by a factor of 1.6-2.4 (3, 56-Sb, 101, 1 l S, 124, 126, 12-, 133. 145. 146). The three studies of nicotine nasal spray reported increases in ab- stinence in the same range (135, 147, 148). The one study of nicotine inhaler found a tripling of the quit rate (138). Loheline has not been shown to he effective (113, 123,149). Higher doses of nicotine gum are more effec- tive in more nicotine-dependent patients (115, 127). Whether higher doses of nicotine patch are more effica- cious is debatable (53). 3) Long-term abstinence trith ntinimal adjrmctive therapy. Often, interventions for smoking cessation consist of brief advice (l0 minutes) plus a prescription for nicotine replacement. Although early reviews indi- cated nicotine gum was not more effective than placebo in this setting, more recent meta-analyses indicate nico- tine gum increases quit rates by a factor of around 1.5 (3, 57, 58, 92, 101, 115, 124, 126, 127). In addition, controlled studies have found that nicotine gum doubles quit rates even when given with no adjunctive therapy; i.e., in an over-the-counter setting (FDA Advisory Panel Hearings, Sept. 29, 1995). The nicotine patch is clearly Am J Psychiatry 153:10, October 1996 Supplement 51770 6904 13
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NICOTINE DEPENDENCE effective when civen with minimal therap}• and doubles quit rares i.i. 34. 56. 101. 115. 1'_-. 133. 14br. Both the 2-3- and 16-hour patch double quit rates even in an over- the-counter settin, iFDA advisorv Panel Hearing. March 1-. 1996j. Finally, although nicotine gum and patch are efficacious in these settin;s, overall quit rate> are low ie.,., 10`%o-20°oi. Nicotine nasal spra~~. nico- tine inhaler, and lobeline have not been tested in this settin,. 4) Patch plcr's gian. Three controlled trials indicate using nicotine gum ('_ mg) ad-lib in addition to a nico- tine patch increases quit rates over either therapy used alone (119). Such combined therapy does not appear to significantly increase side effects; thus, this is a recom- mended treatment (lI). 5) Summary of recommendations. Nicotine patches and nicotine gum are recommended initial pharmacotherapies for smoking cessation I1). Nicotine nasal spray is also recommended hut because it has a smaller empirical base and appears to have significant side effects isee section II1.F.2.d.3), it is recommended as a treatment for those who have failed to stop smoking using the nicotine patch or gum (IIJ. Because of a limited database, the nicotine inhaler is classified as a promising treatment. Lobeline lacks sufficient evidence of efficacy to be recommended. d. Side effects. 1) Nicotine giom. Major side effects from nicotine gum are very rare and side effects rarely deter use (24). Minor side effects are of mechanical origin Ie.g., diffi- culty chewing, sore jaw) or of local pharmacological origin (e.g., burning in mouth, throat irritation). Toler- ance develops to most side effects over the first week (24). Education about proper use of the gum le.g., do not chew too vigorously) decreases side effects t241. Originally, some disorders were listed as contraindica- tions to use of nicotine gum (e.g., cardiovascular dis- ease, pregnancy, hypertension), but given that nicotine blood levels are much lower with nicotine gum than with cigarettes, these contraindications have been dropped (24, 25). The only psychiatriclpsychological side effect of nicotine gum is the continuance of nicotine dependence (15)• Abrupt cessation of nicotine gum can produce withdrawal symptoms similar to, but less intensive than, that from cigarettes (15). Gradual reduction in the use of nicotine gum usually produces no or very minor symptoms (15). About 10%-20% of those who stop smoking with the help of nicotine gum continue to use nicotine gum for 9 months or more, but few use the gum longer than 2 years (41). There are several lines of evi- dence that most long-term use is not dependence. For example, all but 1%-2% of smokers eventually stop gum use, the amount of gum use at long-term follow-up is minimal (usually 12 mg/day), the amount of gum use decreases over time, and weaning off the gum usually requires only education and reassurance even in long- term users (1 S, 41,150). Instead, long-term use appears to most often represent the patient's desire to extend the duration of therapy for fear of returning to smoking if 14 nicotine cum u:r :< snol•nrd. Harmtu: :.. • t•' term use of nicotine cum ha% r no: i•rrr. .u; unlikely given thr a't+srrne ot ext•u.urv n, (ir carbon monoxide and the much irwer ie% ri, ot n:;, tine from nicotine ;um than from ct,arrrtr• ._-. =~ . ?- \uuti,rc p.a.h. Signihcant medical proi•irm• with nicotine patches have nor been ruund ~'-(. 1:1). The most common minor side eftrcte arr skin rra;- tions tS0"o% insomnta and tncrrasr.i or vivid Jrram• 115. 151 1. Tolerance to thrse a.ir eftrcr> umalh .irvriup• within a week. Rotation ot patch sttr• .ir:rra•r!. >icin :t- ritation. Although debatable. inci,mnta reported in the first week postcessation appears to hr mo.tl% due to nico- tine s.•ithdrass il rather than the nicotine patch tt>rlf (152). A 24-hour patch can he removed before br.inmr to determine if the insomnia is due to the m«xinr patch. Insomnia usuallv abates without treatment artrr -i-- davs. Although one series uf case rel+ort> su,aze:te.i con- comitant use of cigarettes and nicotine l+atchrs cau.r.1 mvocardial infarction, later analyses and prospective em- pirical studies in smokers with active heart disease indi- cated this prior report was incorrect t'-3). Abrupt cessa- tion of the nicotine patch does not appear to produce significant withdrawal symptoms, and long-term use has not been a problem (151). 3) Nicotine nasal sprar. The major side effects from nicotine nasal spray are nasal and throat irritaticm, rhinitis, sneezing, coughing, and watering eves (135, 147, 148). One or more of these occur in over three- quarters of the patients. Long-term nasal problems from use of nicotine nasal spray is usually not a problem (147). Whether abrupt cessation of nasal spray pro- duces withdrawal has not been studied. Nicotine nasal spray does appear to have semie dependence liabi)itv, as indicated by the fact that in semie studies, several pa- tients who quit smoking with nicotine nasal spray con- tinued to use it for lon-, periods (147). 4) Nicotine inbaler. No serious medical side ef- fects have been reported with nicotine inhalers (137). About half of subjects report throat irritation or cough- ing (138). Whether some patients use nicotine inhalers for long periods or have withdrawal upon cessation of inhaler use has not been tested. 5) Lobelinc. Major side effects, including abuse/de- pendence, from laheline have not been reported (149). C. 1 nrplcmentatinn 1) Indications. How to decide to whom to give nicotine replacement therapy is debatable (48, 60, 88, 101, 115, 153, 154). Nicotine gum lespecially the 4-mg dose) and nicotine nasal spray are more helpful in highly nicotine-dependent patients (as measured by the Fager- strom scale); however, even patients who are less de- pendent appear to obtain some benefit from nicotine gum (12). The package insert for nicotine patches states they are to be used only by those who smoke 15 ciga- rettes per day or more. No such minimum is given for nicotine gum. On the other hand, nicotine patches are beneficial to both highly and less nicotine-dependent smokers (12, 115, 127, 151). Whether highly nicotine- Am J Psychiatry 153:10, October 1996 Sunnlement 1 51730 6905
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\ICnTINE DEPENDENC:E developed r S-. '10-3 ,. \lost selt-help matrrials are hr- hacrc,rally oriented. \\•hether selt-hell+ rntervznnon: used without additional concact or support increase smokin;; cessation is debatable r 14. i', -1. --'. -4. S-. 921. Reactive telephone counsehm, via a hot-Imr ap- pears to incrrase cessation when added to other self- help interventions ( I0-L--1O6). and meta-arialyses su,,- gest a small positive effect i3, i-r• Self-help materials appear to he more effecriin patients who are less nicotine-dependent I10-. 1081 and more motivated (S-). Use of multiple modes of therapy ie.,.. written materials plus phone contact) appears to enhance the effectiveness of self-help i i5- S'. 1041. Tailoring mate- rials to the specific needs and concerns of each patient also appears helpful ('0, lOS). In summarc, self-help materials are recommended as part of a behavioral therapy package 1111. 3. Educatro„r.tl a,td suppc,rtit•e groups The goals of educational and supportive groups are tcr teach patients the harms of smoking and benefits of cessation and to provide group reinforcement for not smoking. The efficacy of education and group support in themselves (i.e., without the behavioral techniques listed above) is debatable 13. 71. -2, 109). On the other hand, the clinical experience of the Work Group on Nicotine Dependence and other clinicians is that group support is important for some patients; thus, educa- rional and supportive groups are considered a promis- ing therapy 11111. 4. H1•pnosis The usual goal of h}•pnotherapy for smoking cessa- rion is to implant nonconscious suggestions that will deter smoking; e.g., smoking will he unpleasant. Three meta-analyses reported hypnosis was efficacious (56, 57, 92); however, the most recent meta-anahysis did not (3). In addition, several quantitative reviews concluded the efficacy of hypnosis was unproven 131, 62. "41. Much of this discordance is because most hypnosis tri- als have poor methodologies and were excluded from consideration in some meta-analyses or reviews. Given the conflicting evidence, hypnosis is rated as a promis- ing treatment I 1111. 5. Other therapies The goal of 12-step programs for smoking cessation (as modified from Alcoholics Anonvmous) is to have the smoker accept that he or she is powerless over smoking and work through 12 goals (or steps) that help break down denial. Several organizations have outlined how to apply the 12-step model to smoking, and a na- tional self-help organization- Nicotine Anonymous- exists (110). However, there are no scientific tests of 12-step programs for smoking cessation. Exercise might be helpful as it is thought to increase self-esteem, relieve stress, emphasize the new role of an 12 abstinent smoker a• a hralth% pc•r.or:. .ra.: weight carn- Cuntrollyd .%aiu.rnori. ,1;. smcrkrm, cessation have ,rruau:c•.i ntr.c,: :.1 more recent studre• ha% c• hrc•n po.rtr.c• I maior difficulr%• ha: been purrr.crml+iran;r ~c itii iu,n-rr trmrty exercise rr;_rmrn.. Althcru_h rr;rnt rr•r.ir;r: r::- dicatrs psychological benerit u::ur, with Ir," -rntrn>m activitv, whether tncrra>trr, Io%% -Ir% rl ,t:tnrt% mr~iir i1c helpful in smoking crs:.incm h.tN nor been tr.tr,'.. h: summary, ezrrctsr,acttvirx r% a l+rumr>rn; nccr•tpc . Biofredhack, family thrrapt. rnrc•rt,,r.rrn.il titrr,tr+%, and psychudynamic thrrap~ ha% e hrrn u.r.i %% ith orhrr drug dependencies 138- and mrght he• al+plr;ahic tr, smoking cessaticm: hciwrs rr, thrrc• arr either no or rmlt a few descriptions of adapting thr.c• tcr treat .nicrl,rn_. In summary, none of these trratmrnt% ha%r .uttr:rc•nt evidence to hr recommended. iacupuncturc• u:m rrr.i with somatic therapies in the next .r:trun. ~ F. SOMATIC TRE.aT\iE\TS 1. l,rtrudrectio„ Pharmacotherapies can he divided into rrl+iacrmrnt therapy, antagonist thrrapy, thrrapirs to make drug in- take aversivr, and nonnicotine medications that mimic nicotine effects (1 13. 114 1. \onmrdir;aticro scrmatic therapies include acupuncture and devices. The follow- ing arr brief descriptions of these therapies. For more information, the reader is referred to recent descriptive (5 I. 56, 62. 6-. 71. --'. 101. 111- 12.11 and mrta-ana- Iyric (3. J-. 92, 115. 124-129) rrvirWs. 2. \'ic utinc• Rc•placc•mc•ut Thc•r.rpr a. Guah. The goal of nicotine replacement therapy is to relieve withdrawal, which will allow the patient to focus on habit and conditioning factors when ctttrmpt- ing to stop smoking. After the acute withdrawal period, nicotine replacement therapy is gradually reduced so that little withdrawal should occur. h. Description oJ' products. 1) Nicotine gun,. Nicotine ingested through the gastrointestinal tract is extensively metabolized on first pass through the liver (42). Nicotine gum (nicotine po- lacrilex) avoids this problem via huccal absorption (42). The gum contains 2 or 4 mg of nicotine that can he released from a resin hy chewing (113). The original recommendation was to use one piece of 2-mg gum every 1 5-30 minutes as needed for craving. More recent work suggests scheduled dosing (e.F.. I piece of 2-mg gum/hour), and 4-mg gum for highly nicotine-de- pendent smokers is more effective (62, 113). The origi- nal recommended duration of treatment was 3 months. Many experts believe longer treatment is more effective; however, the two trials of longer duration produced contradictory results (41). . Nicotine absorption from the gum peaks 30 min- utes after beginning to use the gum (42). Venous niccr Am f Psychiatry 153:10, October 1996 Supplement 51770 6903
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.\JCOn\L DEPE\DE.tiCE _'. S»rokeless tobacco The prevalence of smokeless tobacco use has in- creased dramaricallv in the last decade ;_' 11 i. Mosr us- ers are young men /212,. Smokeless tobacco provides nicotine via buccal absorption (=11, 212). with a slower rate of nicotine absorption but resultant nico- tine blood levels similar in magnitude to those pro- duced by cigarettes (4?, 213). Smokeless tobacco use. can induce nicotine, deRendence, including a with- drawal syndrome 142, 213). Smokeless tobacco use produces medical harm including gingivitis, oral can- cers, etc. (211-213). Often, smokeless tobacco users have detectable and readily observable oral lesions that can be used as motivators (211). Although the cessation rates with behavior therapy are somewhat low in smokeless tobacco users, behav- ioral therapy appears effective and is recommended (II) (5, 211. 213). The single study of nicotine gum showed no efficacy (214). The efficacy of the nicotine patch, nonnicorine mint snurt. or otnrr cessation of smc,krirs< tc,i'a;;c• n.i%c• no: Nevertheless. gl\•en that smUl.rlr.. ,+•-.. pear nicotine dependent, a trnai c,r n,;rt,n, par;n apy is indicated in those who ha%r iaiir,: i`c•;au.; ,, withdrawal svmptom, 11111. 3. P,rtierrt: u-l.+o srrruke prprs,.•r;.rr; The major distinction arnun,, 1',I'r and ;r„tr, smc,l,rr> is whether the%• are prrmar% or .r;onian t'rr- viously used cigarette:, usrrs. a•.c•;c,ndan I+,trr;,,ar users smoke more intensely t2 13, and tnu, ma% i'e mc,rr nicotine dependent. althou,,h ni;c,tme• drI'rrnic•n;r ,, likely to occur in some pipe and cigar u.c•r:, there ,N nc, empirical data on nicotine dependence or it: trratnirnt in this group. However, based on the data trum aJuit>, pipe and cicar smokers who arr niconnc• drl+c•ndrnt should benefit from the same treatrnc•nt: rr;ummc•mirJ for cigarette smokers (I111. \'I. RESEARCH DIRECTIONS Several reviews have outlined research directions for developing treatments for smokers without concomi- tant psychiatric disorders (60, 66, 101, 213. 21.i-217); thus, the following section will focus only on research directions for the psychiatric aspects of smoking. psychiatric patients are almost completely absent. Stud- ies of the prevalence and incidence of initiation and ce.- sation of smokinF, movement through the stages of change. rates of quit anempts, relapse rates, etc.. are needed for smokers with major psychiatric disorders. A. EPIDEMIOLOGY AND NATUR-kL HISTORY OF NICOTINE DEPENDENCE Nicotine dependence per se has been studied much less than has alcohol or other drug dependencies. To our knowledge there are only two population-based studies of the prevalence and correlates of nicotine de- pendence using the DSM-IV criteria (32, 218) and only one using the Fagerstrom scale (219). Serial cross-sec- tional and longitudinal epidemiologtcal studies of nico- tine dependence are needed to determine a) whether the prevalence of nicotine dependence among smokers is increasing over time, b) whether certain groups (e.g., the poor, those with nonnicotine drug dependencies, those with a history of depression) are especially vul- nerable to developing nicotine dependence if they take up smoking, and c) the natural history of nicotine de- pendence (e.g., how soon does it develop, whether some smokers are immune to developing dependence). B. EPIDEMIOLOGY AND NATURAL HISTORY OF SMOKING IN PSYCHIATRIC PATIENTS Although the natural history of smoking initiation and cessation is quite well described, similar studies in 24 C. \1ORBIDITY FROM SMOKING IN PSYCHIATRIC P ATIE\TS How often psychiatric patients die from smoking-re- lated diseases is not known. Demonstration that many psychiatric patients die from smoking-related illnesses might help morivate psychiatrists to he more aggressive in their treatment of nicotine dependence. Prior case- control mortality studies of psychiatric disorders have often not factored in the much higher rates of smoking in psychiatric patients; e.g., the high rates of cancer in depressed patients may he more related to their smok- ing habits than the competence of their immune system. D. PATIEIvT-TREATIMEIv? IMATCHING As indicated previously, there are a few empirically based studies of treatment-matching strategies for smok- ers with different levels of motivation to quit (39, 70), for different types of behavior therapy (102, 103), and for the use of nicotine gum (12) or nasal spray (147) in highly versus less-nicotine-dependent patients. At present there are contradictory data on how to determine which pa- tients need nicotine replacement (10 1). We are unaware of any data on how to select patients that especially need Am J Psychiatry, 153:10, October 1996 Supplement 51770 6915
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tiICOTINE DEPENDE':CE psvchiarnc sVmptoms or alcohol/drug use, how the pa- tient dealt with high-urge situations• any medication side eftects. etc.• and tailors the treatment accordingly 1111 t6l:• Stost, hut not all, studies suggest that brief follow-ups tincluding telephone callst increase quit rates 1111 (5• 58). 10. Dea)irtg with slips and relapses Since smoking even one cigarette during a cessation attempt very otten portends a full-blown relapse 1861, reports of slips should prompt immediate planning around either changes in behavior therapy te.g.. dis- cuss Wa}•s to avoid or cope with situation that led to slip) or pharmacotherap.• (e.g.. increase dose, change medications) IIIII. lf the patient has fully relapsed, the psychiatrist should praise the patient for even limited success IIIII. The patient and the psychiatrist should then discuss what was learned with this quit attempt and w'hen the patient would like to think about trying again 11111. Most patients who relapse continue to he interested in stopping smoking; thus, the psychiatrist should discuss setting a time to reconsider another ces- sation attempt E. SPECIFIC PSYCHOSOCIAL TREAT\1E\TS 1. Behavior therapies a. frrtrndrectiort. Behavioral therapy is based on the theory that learning processes operate in the develop- ment, maintenance, and cessation of smoking. Many of the recommendations described under psychiatric man- agement Isee section I\'.A.3.1 are acruall.• based on the principles of behavioral therapy. The following sections briefly describe formal behavioral techniques for cessa- tion. For more information, the reader is referred to several recent descriptive (51, 62, 65. 67. 71. 72, 74, 87-91) and meta-analytic (3. 57) reviews of behavior therapy. b. Goals. Major goals of behavior therapy are to change the antecedents (including eognitions) to smok- ing, to reinforce nonsmoking, and to teach skills to avoid smoking in high-risk situations. c. Efficacy. There are over 100 controlled prospective studies verifying the efficacy of behavior therapy (577, 71, 72, 92). Typically, behavioral therapies are a mul- timodal package of several of the specific treatments de- scribed later in this guideline. In most reviews/meta- analyses, 6-month quit rates with behavior therapy packages are 20%-25%, and behavior therapy typi- cally increases quit rates twofold over control groups (3, 56, 57, 71, 72, 90, 92). Given this large database of efficacy, multimodal behavior therapy is a recom- mended first-line therapy Ill. d. Specific techniques. Although multimodal behav- ior therapies have been validated, much less research is available on the efficacy of the individual techniques in the behavioral therapy package. The following sections res•iew each technique .tn.l inJi,.trc rno.c ri:.r: ar; rc, ommendrd treatmrnt:. 1 t Skills trarnru~ rcla/+:rPrc r c~rtr~n:. ~i,ili. rran;n:_. relapse preventicm, and their variant• , probirm oi% nt:;. coping skills, and training in srrr:s mana;_rmc•nt h.t%, patients anticipate a lar;,r nujrther ilr :rtuanon, or nr4 k esses that arr likrh. to Irad to ur-,r• tosmuhr or to pruntt•: a slip te.c.x a parn~. an argument. a thou;,hr . karh on nv eessation, it is cuten i+r:t tcsavea,l hi_h-ria..ituauon. •'I. Later, patients plan stratr;,ic•> to :ork• %%itit rhe••L, .itc!- ations. Behavioral coping tn:iudr: rc•mm in;; omr.rlt tnM; the situation, substituting other bc•ita%wr• r.rr0.- inF, taking a walk t• or utilizing skill, n) m.tn.t_c• thc• tri_ gers te.g.. refusal skills, assrrm enru. time m.tn.t,c•mc•nt. Cognitis'e coping includes idenrtryin;, mala.larrnc thoughts. challenging them, and cuhcntutm;, more rtrr.- tive thought patterns te.g., reminding oneselt ot whv it i, important to stop smoking or that the ur;,c• wrll l+a..,. Another tarcet is to prevent thr ahsnnrn.c• violation rttr; r that transforms a slip to a relapse ir.;_., ncrt Vic•"1n_ a aip as a catastrophei. The results of individual trial> sl+rcittcalh testing relapse prevention have been mixr.l t`tl. 431. Howc•\c•r. two recent meta-analysrs concluded problem a)l%- ing/skills trainin;/rrlapsc prevention significantly m creasescessation ratrs 0. S6); thu...kill: trainin}:/rrlal+sc• prevention is a recommended component treatment IIII• 2/ Stirnrrhrs itintrc,l. Stimulus control usually in- cludes self-monitoring prior to a quit attempt to facili- tate identification of stimuli associated with smoking (•'•4). Stimulus control also includr, initially removing or avoiding cues associated with smoking to reduce urges to smoke. Patients are encouraged to discard all cil;arettes, remove lighters. :tshtrays, and matchr., and avoid other smokrrs and situations associated with smoking. Studies of whether stimulus control is effective on its own have produced mixed result. (3). Howrvcr, stimulus control appears to he avrry helpful pn><rdurr in multicomponent treatment in that it servr s as the base for many behavioral techniques (r.g., relapse preven- tion); thus, stimulus control is a recommended treat- ment component of behavior therapy IIII. .3) Arcrsit•c therapy. The rationale of aversive therapy is to make smoking more aversive and less re- inforcing by inducing mild nicotine intoxication syml+- toms of nausra, dizziness, etc., when the patient smokes. The original version of this type of trratmcnt was rapid smoking, in which patients inhale cigarette smoke every few seconds 171. 72). Mam• well-controlled studies of rapid smoking have been ccmducted, and most reviews and meta-analyses have concluded rapid smoking is ef- ficacious (3, 51, 36, 71, 72, 74, 92). Compliance with rapid smoking, as with all aversive therapies, is difficult, and a strong therapeutic alliance or a priori contracts may he used to improve compliance 11111. ()ther, less- aversive versions of therapy include focused smoking, in which smokers smoke at a regulated rate, and smoke holding and rapid puffinl;, in which patients smoke rap- idly hut do not inhale. Whether these less-aversive tech- 10 Am J Psychiatry 1.53:10, October 1996 Supplement 51770 6901
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NICOT'1'~E DEPENDENCE reported clcinidine doubles quit ratec ti6. 125. 165. hut a ic,urth disa,reed 131. The most common side eftect: tit cIc,nidinr are dry mouth• sedation, and constipation 1165 s. Postural h% ~- potension, rebound hyperrensirm, and depression are rare with smoking cessation treatment s 16>>. Several studies have suggested clonidine is more et•fective in women than in men: however, many studies have tailed to find this association (1651. Although clonidine appears to increase quit rates similar to that of nicotine replacement therapy, the quantity and quality of the scientific studies on cloni- dine are less than that for nicotine replacement therapy. Nevertheless, clonidine mav he an alternative for smok- ers who prefer not to receive nicotine and for smokers who have failed nicotine replacement therapy 1111. h. .anxiolytics. Anxiety is a prominent symptom of nicotine withdrawal (16). In addition, smoking de- creases some measures of anxiety and mav reduce stress-induced anxiety (166t: thus. temporarilr replac- ing the anxiol.•tic effects of nicotine..•ith another medi- cation during the first weeks of cessation might make cessation easier. Diazepam appears to decrease tuhacco withdrawal, hut in a well-conducted long-term clinical trial, diazepam did not increase abstinence (123). Q Blockers can act as anxiolyrics. Placebo-controlled tri- als of metoprolol, oxprenolol, and propranolol have not found that they decrease craving or increase absti- nence rates (123). Older trials found that the nonhen- zodiazepine anxiolytics meprohamate and hydroxyzine were not effective for smoking cessation (123). In sum- man-, the above anxiol.•tics do not have sufficient evi- dence to be recommended. Buspirone is a serotonergic agonist, which acts as an amiolytic hut produces minimal, if any, sedation, abuse potential, or physical dependence. Major side ef- fects to huspirone are rare. Some short-term trials have reported that buspirone appeared to reduce nicotine withdrawal, hut others have failed to find this (123). Buspirone improved short-term smoking cessation rates in unselected smokers and improved abstinence in high-anxiety smokers (123). Because of its favorable side effect profile and some evidence of efficacy, huspi- rone is classed as a promising therapy: c. Antidepressants. A past history of depression and dysphoria prior to, at the onset of, or during smoking cessation predicts failure to stop smoking: thus, anti- depressants might be useful in helping smokers with these problems stop smoking (2, 167). In the only pub- lished long-term clinical trials, imipramine had no ef- fect on smoking cessation (123), hut a more recent trial of nortriptyline was positive (168). Two trials with flu- oxetine were completed some time ago but the results were never published or presented /123). Short-term, trials with doxepin, tryptophan, and hupropion in un- selected groups of smokers have also reported promis- ing results (123). Many antidepressants have substantial side effects and a long delay in efficacy; thus, these treatments may not be acceptable to the general population of smokers. 16 rr..i:nt. :C•- .t .. A , more t~,Lu•c•U at'F`r,,.t;i, rnt-n: i•c- ~. tJ r1+rCCs•1nt~ prior to ce...itlon 11' tn: smc,krr:with a past hs:u,r% s,r drrrc•.s,n, s,r s:• .a,o-,-o who are dysl+ht,ri: at the timr s,t niokmc I:• summary. antideprrssant: arc :sma.irrr.i t rrs,ms.s:s, treatment. d. Sturuihtrrta. The goal here I, to rrl+l•t;r thr tsniuiant rfke-t; e,t nicotine sr.,.. iml+rs,vr.f e•nrr,v and :un.rsetr.i- tiuni with a medication in the tsr:t wrrk• sir The one long-term :tu.l% s,t a:nmul•tnr rs,un,i that am- phetamine: did ncx rncrra:r ah:trnrn:r 1 1_: .:\ rr;rnt uncontrolled trial su;ggr.ts methvlrhrns.i•uc.ir:rra.r• ts•- hacco withdraw:tl l 1691. Fin,tlh , it :ttmul,tnt: %%rrr tsnin.d to he effectivr, whether drprndrn:r on the :nmulant s+.:- curs would need to be examinrd. ln sununary. xtm1ul.inn lack sufficient evidence to hr recommended. c..•irwrcctics. anctrectics were used initiallv to :smihat postcessation hunger and wri;,ht ;zain hr:au.r thrw arr two of the most n•ideh• cited rrascm: for difficuln- in stnp- ping smoking t--). Short-term trial. of %t•ennen with weight concerns reported that both tcntlurammr and phenylpropanolamine reduced postcrssatiom wrr,ht gain and some withdrawal svmptumd and tn: rra.rd ah.nnrn%:r (123). The results are intriguing, given the data th it controlling weight by adding a dieting component to a multicomponent pttrgram worsrns rather than impmve• abstinence rates ('8, '9). Fentluraminr and phrm•Il+ro- panolamine have few side effecr.. in stnnmarv, hoth of these medications lack sufficicnt rvidrne•c to Ix recom- mended hut are considered prrnnising . 6. Scnsnrr rcpl.rc cmcltt Black pepper extracts (1-0), ca{+s•iicin (1'1), dcni- cotinizrd tobacco (1-?), tl.tvr,ring,. 11-.:1, and reLrttcr- ated tdrnicotinizrd) smoke (1-•3t all decrease cigarette cravinr or withdrawal or suhsnturr for the satisfaction frrtm cigarettes in laboratory tect~. A citric acid inhaler has been developed and showed semte promise in two clinical trials ( I'i, 176). As expected, this treatment has very fc.v side effects. Since sensory treatmcnts c<iuld he used not cmlv as a stand-alone therapy hut also as an adjunct to traditional pharmacuthrrapies, this appears to he a promising treatment. 7. Other mcdicatiuns Sodium bicarbonate has been used to decrease the rate of urinary elimination of nicotine and thereby de- crease withdrawal symptoms (123). ACTH has been used to decrease postcessation hypoglycemia (123). Anticholinergics have been used to reduce a hypothe- sized cholinergic rebound upon smoking cessation (123). Dextrose has been used to prevent smokers from mislabeling hunger as nicotine craving (123). Homeo- pathic remedies and nutritional supplements have also been proposed. For all of these treatments, the basic rationale and mechanism of action is suspect and con- trolled trials of long-term abstinence are lacking (123); thus, all lack sufficient evidence to he recommended. Am J Psychiatry 1.5.3:10, October 1996 Supplement 51770 6907
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hchavior .rher.tp}• ~lost imF'ortinth tnr thi: Fuidrline, ncerc arc' n" d''t' fe;s~c,n~c~rn~thrrr`.~~th at liediu~h ~rrc ahuce, anaen. dtp p sh00ld he marched a~ specific tcarment>. E. TRE.aTSIEN'T OF SMOKING IN PATIENTS WITH A CURRENT PSYCHIATRIC DISORDER One study has shown that behavioraUcognitive ther- ah%' for depression is especially helpful with smokers with mild depressive sYmptoms ( I I+0• 195). Other stud- ies have tested treatments for smoking among those with alcohol and other drug dependencies, but none have had much success (34). As described earlier, smok- ers with nonnicotine ps}•chiatriddrug disorders appear to have more difficuln• stopping smoking l2, 16 i I; thus, studies of efficacy of treatments of different content and duration in smokers with past or present histories of spr:Itt: 5:11izuphR•nl.l. arc nrr.lr,t. F. TREATSIE\T t)F \C'ITHI)R.a\C :U FREE l'\IT: As described earlier. :r\rral stu.iic•, h•t%r tuun.i tii.t: smoke•free units are not a. .ltfri:uit to mana,r .i, rr: - dicted ! 1901. HHowever. thr:au.r :mokm_ :r.>anon• causes nicotine withdrawal :vnirtoni% tiiat o%rriar with many psychtatrt: symrtumN tr.,._ trnt•irllin• in- somna!, crssatum ha: hrrn hypouhr>trrd to, tntc•rtc•rr a•ith psychiatric dia,,n<tsts, to %%or>rn .r%rr.ti p.%:ht.tt ric disorders, to cause relapse in .omr 1+attrnts in rrmi•- sion, to mimic or worsen side rftrct: trom .e\ rral mr.ii- cations, and to substantially increase blood Irvc•I, or several medications ('_, S). Whether thr.r rftccr. .in• clinicall.• significant needs to he studied. VII. INDIVIDUALS AND ORGANIZATIONS THAT SUBMITTED C:O\lME\TS We thank Barbara Lascelles for her excellent secretarial help with the mul- tiple drafts of this document. Dave Abrams. M.D. Andrew Baillie, Ph.D. Tim Baker, M.D. Richard Balon, M.D. Thomas Birrker. M.D. C.H. Blackron. M.D. John Blamphin Sheila Blume, N4.D. Ralph Bohm, M.D. David W. Brook, M.D. Sara Charles, M.D. George J. Cohen. M.D. Sheldon Cohen. M.D. Dave M. Davis, M.D. Praksash N. Desai, N1.D. Leah Dickstein, M.D. Karl Olov Fagerstrom, M.D. Michael Fiore, M.D., M.P.H. Saul Forman, M.D. Tom Glynn, Ph.D. Larry S. Goldman, M.D. Marion Goldstein, M.D. John Grabowski, Ph.D. Sheila Haher Gray, \l.D. Donna Grossman, J.D.,.M.P.H. Harry A. Guess, \1.D., Ph.D. Frederick G. Guggenheim. M.D. Joseph HaRan, M.D. Dorothy Hatsuk:imi, M.D. Al Herzoc, \1.D. Richard B. Hevman, M.D. Richard Hurt, M.D. Corinne G. Husten, \l.D., \1.P.H. Martin Jan•is. M.D. Elaine M. •lohnson. Ph.D. Nalini V. Juthani, M.D. Lori Karan, .U.D. Robert l:immich, .\1.D. Martha Kirkpatrick. M.D. Thomas Kittke, M.D. Harry Lando, Ph.D. Alan l. Leshner, Ph.D. Edward Lichtenstein, Ph.D. Velandv Manohar, .'11.D. Ronald Manin, M.D. Tom McClellan, .ti1.I). Roy Menninger, M.D. Michael Meyers, .\7•D. Jane Moore Jerome Motto, M.D. Rcxiriro Munnz, \l.n. Jim \iningcr, \l.h. Claire Palmer Christi Patten. Ph.D. Ruizer Perlc, \1.1). Herbert S. Pe.•scr, \1.D. Paul Pilkoni., I'h.l). Robert F. Prien. Ph.l). Ghulam `adir, \1.1). Vaughn I. Rickert, Jrd E. Rose. Ph.D. Pedro Ruiz• \t.I). Mitchell L. Scharc, Ph.l). C:harles Schuster. Ph.D. Paul M. kM•rc, \t.t). Saul Shifftnan. Ph.D. C:hri. Sila1;}•, M.D. John Sladc, M.1>. Nada Stotland, M•1). William R. Tatomcr, M.D. Robert TrachtcnFxrF, J.D. Carol Martinez Weher, M.n. Jt»eph Wrsterme.•er, \1.D., Ph.D. Dou};las M.C. Wilson, M.D. Steven H. Woolf, M.D.. M.P.H. Valcn• W. Yandow, M.D. Am J Psychiatry 153:10, October 1996 Supplement 51770 6 916 25
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The use of various substances to modify mood or behavior is generally regarded as normal and acceptable in our society, despite wide cultural differences. Many people drink cof- fee or tea for the stimulant effects of caffeine, or engage in the social drinking of alcohol. And certain drugs may be used medically to relieve tension or pain or to suppress appe- tite. When the symptoms and behavioral changes associated with regular use of these substances become maladaptive, however, substance use turns to substance abuse. OCopyright 1988, 1989 American Psychiatric Association Produced by the APA Joint Commission on Public Affairs and the Division of Public Affairs. This pamphlet was developed for educational purposes and does not necessarily reflect opinion or policy of the American Psychiatric Association. Revised 1996 ,wk .~~.=. 11111111 1• 11i1/ DEP The American Psychiatric Association is a cosponsor of the National Public Edu- cation Campaign on Clinical Depression in cooperation with the National Mental Health Association, Nation- al Alliance for the Mentally Ill, National Depressive and Manic Depressive As- sociation and the DEPRESSION Awareness, Rec- ognition and Treatment (D/ART) Program, National Institute of Mental Health. Substance abuse-the misuse of alcohol, ciga- rettes and both illegal and legal drugs-is by far the predominant cause of premature and preventable illness, disability and death in our society. Alcohol and drug abuse afflict an esti- mated 25.5 million Americans. When the ef- fects on the families of abusers and people close to those injured or killed by intoxicated drivers are considered, such abuse affects un- told millions more. The annual cost of alcoholism is $89S billion for treatment and indirect losses such as re- duced worker productivity, early death and property damage resulting from alcohol-re- lated accidents and crime each year. Drug abuse accounts for another $46.9 billion a year in direct and indirect costs to business and the economy. This economic toll amounts to over four times that of cancer and nearly a third greater than that of cardiovascular dis- ease, according to a 1984 Research Triangle Institute report. Among the disorders related to the misuse of these substances, a distinction is made be- tween substance abuse and substance depen- dence. Substance abuse victims can't control their use of alcohol or other drugs. They be- come intoxicated on a regular basis-daily, every weekend or in binges-and often need the drug for normal daily functioning. They re- G1 N
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2. Yntd1• Despite a large public health ettort. the prevalence of smoking in teens has actuallv increased in the last :years (Monitoring the Future. 199:, unpublished data:. Thi: increase appears to he associated with tohaccoadvertisin, i5:. Although policy initiatives focused on illegal sales. taxation, and vending machines are essential to combat- ing smoking among youth, provid;n; treatment for smok- ing cessation'also could be helpful. l'oun, smokers appear to develop nicotine dependence fairly ~quickly, in that many have withdrawal when they try to quit. and most find it difficult to stop (5I. Smoking is highly correlated with alcohol/drua problems in youth t37r thus. screening for comorbidin• in this group appears important. There are few studies of smoking cessation treatments for ado- lescents, and none that show high long-term quit rates (it: however, the Work Group on \icotine Dependence found no reason to believe that the psychiatric manage- ment strategies ttable') and the psychosocial treatments Itable S t effecri.•e in adults would nor beeffective in vouth; thus, these are recommended 11II). Whether nicotine re- placement therapy would be of help in this group has not been tested (5); however, based on the results from adults, youth who are nicotine dependent le.g., have withdrawal symptoms upon cessation) should be considered for nico- tine replacement therapy 1111j. 3. Gender Although earlier studies suggested women were less likely to succeed in stopping smoking, more recent data suggest women are quitting at same rate as men (203). The factors that undermine cessation in women appear to he depression, social support, and weight gain (203). Some data have suggested men do better with nicotine replacement therapy (203) and women do better with clonidine (165); however, these findings have not been consistently replicated. Whether women have more withdrawal symptoms and are more influenced by so- cial support than are men is also unclear (204). There are no replicable empirical data on how to tailor smok- ing treatments to the needs of women (203). Smoking during pregnancy is associated with increased perinatal complications and low-birth-weight babies (205). How much of the low birth weight is due to nico- tine-induced vasoconstriction of the placental artery or carbon-monoxide-induced hypoxemia is unclear (205, 206). If a woman stops smoking within the first two tri- mesters, her risk of having a low-birth-weight child is near normal (205). Female smokers who do not stop early on in pregnancy appear to be highly nicotine dependent (24). Behavior therapy tailored to this group appears to be ef- fective and is recommended (I1) (73, 205). Weight gain concerns and depression may undermine resistance to ces- sation in this group and need to be addressed (III) (73, 205). Many pregnant smokers relapse immediately post- partum (73, 205); thus, special emphasis on maintaining abstinence postpartum is indicated (IIJ. The use of nicotine replacement therapy in pregnancy is dehatahlr -tM . Rr:rn; .ia:.. .~: . nicotine itselt :oul.i acivrr:ri% tn; .iL,%riwr;n_ ;; tral nrrvous svsrrm ._ll- -: howr% er. the 10 ; i0r to which the fetus is exposed j> mu:h itmrr rromi n;;0• tine gum and pat:h than fmm ,;,arrttr!. \;;orntt rL - placrmrnt therapy should still be ccm.;drrr.i in prr:- nanr s%-omrn who ha%r tried to stol+ dunn; rhr;- pregnancy hut have not been ahle to do .o or withdrawal srmptom. (1111. It nicotine rrpia;rmrnt i• usrd, the woman should understand thc• hc•nctitN an.: risks of nicotine replacement thrral+%, and thr :lin;:;an should consider a lower dose and a shortrr juraticm oi treatment to reduce frtal exposure to n1<0t1nr Illll• 4. Racc%th,ucrt}• In examining the association of r.nr, culrurc, or rth- nicin with nicotine and other dru~~ Jrpritdrn~r, it i~ important to differentiate sociudrmo,raphi, tactur. te.g.. income, educaticm, from ra:eiethni;ity ta.tors (208). Blacks are less likelv to initiate smokin;g, smokc tewer cigarettes per day t 1 1 1, and appear to he less likely to become nicotine dependent 011, hut have higher cotinine levels and are less likrly to stop smoking than whites (208). There are no replicable empirical data on how to change the furm or content of cessation therapies for blacks versus for %%•hitrs (_'0a). 5. Socioeconomic status Smokers who are nonprofessionals, less educated, or poorer are more Iikel.• to start smoking and, once the~ start, are less likely to stop (11, 209). Although not well studied, smokers of low socioeconomic status prohabl.• have less social support for cessation and mav have less knowledge of the harm from smoking and the benefits of cessation (209). Finally, these smokers have less ac- cess to formal therapies for smoking cessation (209). One study of providing free smoking cessation therapy (i.e., nicotine replacement therapy) to low-income smokers found quit rates similar to those of higher so- cioeconomic groups (210). There are no replicable re- sults to indicate how to mc,dif% • treatment for smokers of low socioeconomic status. D. TYPE OF TOBACCC) 1. Cigarcttes The data and conclusions cited in the previous sec- tions are for treatment of cigarette smoking. Cigarettes comprise over 95% of tobacco consumption in the United States (11). Cigarettes are very dependence pro- ducing because the inhalation route produces high arte- rial concentrations of nicotine that very quickly reach the brain (15, 42). In addition, the cigarette is a delivery device that allows easy titration of the dose to achieve different effects (15, 42). Finally, the high availability of cigarettes and multiple cues for their use make cessa- tion difficult (15, 42). 51770 6914 Am J Psychiatry 153:10, October 1996 Supplement 23
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J 3 peatedly try to stop using the drug but fail, even though they know its use interferes with their family life, social relationships and work performance, or that it causes or aggravates a psychological or physical problem. Substance dependence victims suffer all the symptoms of abuse plus a tolerance for the drug so that increased amounts of it are neces- sary for the desired effects. Opioids, alcohol and amphetamines also lead to physical de- pendence in which the person develops with- drawal symptoms when he stops using the drug. Alcohol Use For no other disease more than alcoholism has social stigma blocked the road to under- standing. Society has long viewed the afflic- tion as a psychological problem-the sign of a ravaged soul devoid of discipline or morality. Physicians are inclined to ignore its symptoms and victims deny its existence. 0 Alcoholism is a progressive disease that generally first appears between the ages of 20 and 40, although children can be- come alcoholics.  Drinking patterns vary by age and sex. At all ages, two to five times more males than females are heavy drinkers. For both males and females, drinking prevalence is highest and abstention lowest in the 21 to 34 age range. Among those 65 years and older, abstainers exceed drinkers in both sexes.  Alcohol dependence tends to cluster in families.  Alcohol dependence is often associated with depression, but the depression typi- cally appears to be a consequence of the drinking rather than a cause.  It takes five to 15 years for an adult to be- come an alcoholic; an adolescent can be- come an alcoholic, by contrast, in six to 18 months of heavy drinking. Recent scientific breakthroughs, however, have begun to dramatically alter our views on alcoholism. The myth that alcoholism is al- ways psychologically based is yielding under the weight of evidence that the disease is largely biologically determined. This news holds significant hope for the estimated 18 million adult victims of alcohol (10.6 million alcoholics and another 7.3 million with seri- ous alcohol abuse problems), as well as the 56 million people directly affected by them. Such discoveries may eventually lead to prevention or detection of the disease before its damage becomes irreversible. The following characteristics of alcoholism leave little doubt as to the devastating impact of the disease:  Generally, abuse occurs in one of three patterns: regular, daily intoxication; drink- ing large amounts of alcohol at specific times, such as every weekend; and long periods of sobriety interspersed with binges of heavy daily drinking that last for weeks or months.  As drinking continues, dependence devel- ops and sobriety brings serious with- drawal symptoms such as delirium tremens (D'Ik) that include physical trem- bling, delusions, hallucinations, sweating and high blood pressure.  Long-term, heavy drinking can cause de- mentia, in which the individual loses memory and the ability to think ab-
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NICOTINE DEPENDENCE treatment articles. Other databases searched were the Center for Disease Control and Prevention's Bihli(~-,- rapht• on Snrukrng and Hcalth 16i. the Oxford Col- lahorative Trials Registry i-J. and the bibliography of the AHCPR C/i,rica/ Practicc GrrJdcCnrc on Smokirr; Cessation i31. In addition, references in empincal arti- cles and narrative and meta-anah•tic reviews were used to locate articles. . . .. For hrevin•, mera-analyses and reviews of treatments for smoking are usually cited in the guideline instead of original studies. Howe.•er, the conclusions of the work group are based on knowledge of the individual studies included in these meta-analvses and reviews and on other pertinent studies. iii. EVIDENCE RATINGS Each recommendation in the guideline receives one of three categories of endorsement using a bracketed Ro- man numeral tollowin_ thr !~tatrm;n:. Tii, tar.: :at: ;oriesarr based on the:.trntin; iit;r.ttur, an.i or ::,n cal expertise and represent varying Ic•% ci, or ; iini:.t; :ov fidence in the recommendation. Tnrre %ar% in; ,i,_rrr• of clinical confidence are noted: I1I Rrcommrndr.l with :uh>tantial ;hni:.t; 01itt- dence. These rrcommenditiom: are u,uall, h.t.c.l cii: several well-controlled clinical rrial, that rrportr.i .imi- lar findings or represent key prin.il+lc•• tit ;hni.a1 p- chiatric care with broad rxl+rrt ;on•rmu•. JIll Recommended with mo.1c•r.ttc :Imi:.tl ;onh- dence. These recommendatiun> are• u•uall% ha:r.1 on a few positive studies or on Irs:-<<~n~tarnt .iata tnom many sources. [111] Recommended with lower clinical contt.lrn:r or recommended on the basis of individual :tr.umsrancr.. These recommendations usually have not been .t.lr- quatelv tested or have conflicting rrport..ihour ctfi;.t:% hut are consistent with expert opinion and with a:- cepted principles of treatment of smoking. 1. EXECUTIVE SUMMARY The following executive summary is nor intended to stand hy itself. The treatment of smoking cessation re- quires the consideration of many factors and cannot be adequately reviewed in a brief summary. The reader is encouraged to consult the relevant portions of the guideline when specific treatment recommendations are sought. Recommended psychiatric management strategies that all smokers should receive are listed in table 7 lsee page 7). Table 8 lists the recommended treatments and their ratings (see page 7). There are a number of promising treatments for nico- tine dependence that may he recommended based on individual circumstances. These include intensive be- havior therapy 11111, educational/supportive groups 11111, exercise 11111, hypnosis (1111, anorectics 11111, anti- depressants (1111, buspirone 11111, higher-than-normal dose transdermal nicotine 11II], mecamylamine 11111, nicotine inhaler 11111, and sensory replacement 11111. Treatments that cannot be recommended at this time for the treatment of nicotipe dependence (either because of data indicating lack o (Aicacy or lack of sufficient evidence supporting efficacy) include: contingency con- tracting, cue exposure, hospitalization, nicotine fading, physiological feedback, relaxation, 12-step therapy, ACTH, acupuncture, anticholinergics, benzodiaze- pines, 0 blockers, glucose, homeopathics, lobeline, nal- trexone, nutritional aids, reduction devices, silver ni- trate, sodium bicarbonate, and stimulants. Psychiatrists should assess the smoking status of all their patients on a regular basis. lf the patient is a smoker, the psychiatrist discusses interest in quitting and gives explicit advice to motivate the patient to stop smoking, including a personalized reason the paticnt should stop 111. When possihle, advice may come tntm multiple sources in addition to the psvchiatrist; e.l;., from other physicians, nurses, social workrrs, etc. Ill. Written materials may he used as well as facr-to-face interventions JI1l. Since nianv psychiatric patients are not ready to quit, the goal of advice will often he to motivate patients to contemplate cessation hy revieH•- inl; the benefits of quitting, discussing barriers to quit- ting, and offering support and treatment 11111. If the pa- tient is interested in stopping smoking, a quit dare should he elicited, treatment prescribed, and follow-up arranged J11l. The minimal initial treatment for those who wish to quit includes written materials, brief coun- seling, and a follow-up visit or call 1-3 days after the quit date 1111. if the patient has failed serious attempts without for- mal treatment, failed with nonpharmacological thera- pies, had serious withdrawal symptoms, or appears highly nicotine dependent, transdermal nicotine is rec- ommendrd 111. If the patient prefers or if ad-lih dosing is needed, nicotine gum can he used instead of transder- mal nicotine 111. If used alone, nicocine gum is to he taken on an every-hour basis 111 . !f the patient is a highly nicotine-dependent or heavy smoker, higher- dose nicotine gum should be used I 11. Nicotine gum can also be used on an ad-lib basis to supplement transder- mal nicotine therapy JIl I. If the patient has had trouble stopping smoking for nonwithdrawal reasons (e.g., due to skills deficits). he or she is a candidate for multicomponent behavior ther- apy (IJ. The more effective components of behavior 2 Am J Psychiatry 153:10, October 1996 Supplement _ 51770 6893 -
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RESIDENTIAL SERVICES IN THE NEARBY COMMUNII-v ALLOW SOME PATIEhTS 10 LIVE IN A SUPPORIIVE. STRUCTURED E:NVIRONMENT THAT IS F'AR l_F-:.SS NFStRICTIVF: THAN THE TRADITIONAL HOSPITAL SErTING ZL99 OLLZS Inliatirnt sc•ttit t•s :u 'I'h<• Itr.,tilulc• :ut• :tN',tiLtltlc• Iclt :ulult•sccc•ttts, :ulult.,, :tncl ublt•r ;ulttllx, :ts wt•11 :t. liu tilx•t ilic lr•uicnt I'c'I'itLuiun.. 'I'tt•auuc•nt Itl:utti lut inlFalic•nl.:uc• Iti;;lth iucliviclu:tliit•cl, as i. Illt• rasc• ill c>tltt•r IF,u t. uI thc• .vstc•ut. In.lilutc• sltcrialistti art• t•-,Ix•t it•ntt•c1 ill ut•atitug all ltstirhiait ir cii:tg ncnt•.ti, inrlutiin}; %cltiiultltrt•ui:t, t•:uiu}{ tlisuttlt•r.., clcltrestiicFrt, ltil>nlar disurtli•r, c11FSt.~i~c-t/lntltulsitr tlisurFlcr• and irnn'actaldt• illnt•.ses fittutci tcr rt•.i,t u't•autucul clsctvlu•rt•. (:)ur clinicians art• al.u skillccl ill trcatin}; t-Itt•tuital cIt•I,cnclcncv disurtlet.ti. lultaticnt catt• at 'l'he Ittstitutc ctf Li.'ing scne•s a. Inurc than :t a:telin}{ IuFin1 ill utu. syxle•ut cFf cvt•. I1 nctrssary, Itauit•lus ill Flav Lt-t•atntt•nt aucl utltrr antltulatcttti' prugr:uus utay t•tttrr 1 Itc Irn.tilitutt•'s 1luatital x1 any timc. 'fhc Irtlit•nl will br st:tltilirctl as clltickly as pUSSiltle antl rcturnt•d lu :t less inle-tt.ivt• .rlting. 14'lu•u utctlic:tl euutlrlicatiunS uet-ur• llte• Institntt• tnainlaiux a slaff u/,ltlty'sicians ttainccl ill intt•t nal nu•clicint• ancl cttlx•r subshecialtics. R E S I DENI'IAL. lhrtra;;L ilc .errG.cirliru••t•. Intilitutt• IIt•altlt t:art•, lnt'.•"lltt• ~_ Inailttlr ctI I.ivinl; cFlli•rs :t t-utultrt•Itt•nsive nt•Itvurk ul rt•.itlcntial Itru};r:ttu.ti fut' ltaticnts wltct cltF ncrt n•<Ittirt• husltit,tlii:uiutt, hu1 still ucct) sultlx,rt :tncl strurtun• :ts tltt•y ntu%•t. bu k intu tht• c'utuutunily. Rt•tiitlrncr( ill tht• nt•:u ity c-utuntuuily ;uu1 c In unr c:uultus ItruN'iclr slructurt <l ItnF{;r:uns ill hutnt•likc• st•Itiul;s tlt,tt Itruntutt• tltr tlt•vc•lul,nu•ut trCstu ial an(t lile•.kill.. A It•:uu ul'sutll tut•ntlx•rs sulx•tvist•s t•atlt t'c•si(It•nce•, cc>urclin:Uitt}; Ircauut•nl Ittetgtants aucl as.isliu}; IxF11t t-t•sitlt•nls ancl Iltt•r,ytias. Fur Iltux• whcF rrtlttitt• le•,...ultt ta.c ntan:t};rtut•nl st•tviecs ln'ovitlt• 0 Sttltliurl tltrttu;;it tcc•t•Lh ' ~,isits tu Iltt• Ituutc•- c/f Irttit•nts wlut liNt• inclc•Ix•nclc•utlv. Itt•sitlt•ttlial ItrF,'.tattt.tan:tai,t ill IIu• u;ni.iiil/u ltutu Itutiltitalii:Llictn tu intlt•In•nclrnt If\iiit{, Ilt, in nlaM caa•S, luncticFn as:ut altt•rtuatirt• tUl iult:ui<•tU c;ut•. flu•t'scn'c a l,rl,atl sln•cu ntn Ilf IrUicttls Muta• a};t•, ctnll m•%~rriiv ul illur.e cliili,t witlch'. OItt•u, Italicuts art• rrti•rlc•cl intli.l/tu rt•.,iclt•ntial lttup;rauts Ity cuntlnunitto, tltt•r:yFiay x hu cucttitlttt• tu tY'ctrk tvith Iltc Iruit•ttl. l'lilii,:uictn ul'l ltt• Irnslitutr'ti rcsitlt•ttlial .crvitt•s eaticti liuttt Ix•etiutt IIt pt•r.un, ltut irn t•aelt c:FSt• rctiitle•ntial lartn;ratus rt•Itrescnt a ccFSt-cliiricnt attcl clitticallp t•flt•cliw altt•rn:uirc tu hcFSpilaliialiun Ilt:tt t:ut lc•acl tIF ut tiv Itus.iltililirS fur uraUUt•nl antt rt•c<Ftct-N. - PAkTtAt_ hloEt'~IAt_ (DAV C/tt EVl3r.ING1 Srrrrrlifir udr•uuev.c irr lr•t•bnulu-t•, lrsyrhutltt•tal»',:tn(1 ltsycltultlrttutarulu};)It:nr cutnlFiuctl IcF ntakc It;utial htrsltital Inu};r:uns an int'rt•asingl~' altr:Cti\t• altt•tn;ttivC tu inlt:tticnt rarc•. t'aticnts tnay cntrr uraunt•ut at tltiti Ic•vcl ul <:tn• tFr utay ttieel this Icwrl uf'sultpurt li/lluwins, :ut inlr.ttit•nt aay. FIti•clitr as wt•II as rllit it•nl, Ilau tial tIa}' aull cwnittti pru};r:utt, uffrr I ltt• a(Itlt•t1 :ult:tutag(• ctI :111utvittti IMuit•ttIs It) tlntlt•rgcF Itc:tlutc•int wltilt• lit'inl{ al Itntnc FFr ill Iltt• Tlruununit~', ancl• Ill .ctutt• ra.i•s, ttihilr ClFlltifltliltg tu IrilrSllc a ratt•t•t. I
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\:~ +`?:\: 1IF i'~ \DL \+ t therapy appear to he skills traintnrrelapse prevention: rapid smnkin,. in which patients tnhale ci,,arettr smoke every tew seconds: and stimulus control strate,ie, 11111. Some smokers also appear to benefit from ,roup sup- port Combined behavior therapy and nicotine replace- ment tmpro.'es outcome over either treatment alone and is recommended when available and acceptable to the patient lIk.howeaer, attending behavior therapy should not be a prerequisite to receiving nicotine re- placement therapy 111. For the smoker who has failed adequate treatment, as described previousl.', and who is interested in making another attempt to stop smoking, the psychiatrist should assess the adequacy of prior treatments and evaluate the patient for ongoing or residual alcohol, drug, or psychiatric problems that need treatment /Ill. )f the patient has previously failed an adequate trial of transdermal nicotine and relapse appeared to he with- drawal related, three options are reasonable: a) ad-lib nicotine gum added to transdermal nicotine (II1, b) oral or rransdermal clonidine 1111, or cl nicorine nasal spray JIIl. It relapse was due to reasons other than withdrawal ~c.:.. stres: . multtcOmr'cmrn: i•:n.t% u+- tr%'-,::'+ hr:unsidrrrd ll'1. It tnc• panc•n: a.t• .ta0n,::. su:h therapi. more tntrna%r tncin t.iu.t i•~ it.t~:c+r ti%• ap.•:r.,.. 1- , _ ttmr:,%crrl, tur 2-3 ~%rri.. ~nc+ui; i% sidered 11111. P>vYhlWrrt: and 2rnrra) nlrdl: al patlCtlt• -,\'tlu .Itk+w; and arr on smuicr-trer ward: cnc+ul.i rr:rt%r :irar a:• strucrtllns about the no Snlolan-u, ,1d\'I:l' t+' ~;ri+^ smoktn;,. and r.iucanun ahc,uc tiu• :vml+tc+m. .tn,i ttm; ccwrse ot ntcottnr %vith.ir.twal 1111;. Thr.r l+.itcrnt• who wish to use the smc+ice-trrr ward tc+intttatr a ac+l•.mc+i.- inz attempt may receive the thrral+n•• outitnr.i prv• vIOUSIy 111. hatlenti who do nor wI>h t++ sh+r >nlt+kIn_ permanenth' and %%'hc+ rvi.lrn:r nt:otmc wtth.ira.val mav he instructed in behavioral :tr,trr_tc•, n+ .ir:rra•r withdrawal symptomc 1I)11 and prc+vidrd nt:cmnc• rr- placemenr ipatch or gum) 1111. There is a possibility that smoktn~, cr:.aticm mt;;ht modify psychiatric symptum: c.rc• tahlc• (•, page 3 - .u:h that it interferrs with the diagncca, and treatment c+t psychiatric disorders (S). C:rssittun can al.c+ drantati- calh' alter blood levels of some psychtatrt: mrJtcatum. Isee tahlr 5, page i) (S) 1111. II. DISEASE DEFI\ITIO\, EPIDEMIOLOGY. AND \ aTURaL HISTORY A. DSSI-1\' \ICOTINE USE DISORDERS DSM-IV includes nicotine dependence and nicotine withdrawal as disorders. Nicotine abuse is not included because clinically significant psychosocial problems from tobacco use are rare (9). Nicotine intoxication is also not included as it is very rare. B. SPECIFIC FEATURES OF DIAGNOSIS 1. ,\icatine dependence Examples of how the generic' DS,`!-IV criteria for substance dependence apply to nicotine dependence are illustrated in table 2. The applicability and reliability of the DSM dia,gnosis of nicotine dependence appears high (10); however, its validity has not been well tested. Another widely used measure of nicotine dependence is the Fagerstrom Tolerance Questionnaire or the more recent version-the Fagerstrom Test for Nicotine De- pendence (table 3) (11, 12). Scores of greater than seven on these scales indicate nicotine dependence. The severity of nicotine dependence can be illustrated by the fact that only 33 % of self-quitters remain abstinent for 2 days and fewer than 5% are ultimately successful on a given quit attempt (13, 14). The strength of nicotine dependence via cigarette smoking is due to several fac- tors: a) nicotine produces a multiplicity of positive rein- forcing effeas (e.g., improved concentration and mood, decreased anger and wright), h) a hctlus of nicotine reaches the brain within 1(1 seconds after inhalation, producing an almost instantanrous cffrct, c) nicotine dose can he precisely controlled hy the %%'at' a cigarrtte is smokrd, d) smokins; occurs frequently Ir.g., a pack-a-cla% smoker self-administrrs nicotine about 200 times a day), and e) there are many cues for smoking (15). Nicotine dependence and withdrawal can develop .vith all forms of tobacco u.r (i.r., cigarettes, chewing tohacco, snuff, piprs, and cigars) and can be maintained with nicotine replacement'(i.c., nicotine l;um, patch, and nasal spray) (16, 17). The ability of these products to induce or maintain dependence and withdrawal in- creases with the rapidiq• of absorption of nicotine, nico- tine dose, and availability of the product (1S). Smoking has been laheled the most important pre- ventable cause of death and disease (18, 19). Smoking is responsible for 20':1, of all deaths in the U.S., and 4i".t of smokers will die of a tobacco-induced disorder (20). Cigarette smoking causes lung, oral, and other cancers, cardiovascular disease, chronic obstructive pulmonary disease, peptic ulcers, gastrointestinal disor- ders, maternal/fetal complications, and other disorders (20, 21). Secondhand smoke causes the deaths of thou- sands of nonsmokers and morbidity in children and other relatives of smokers (22, 23). Smokeless tobacco, pipes, and cigars also cause oral cancers and other problems (20). Although nicotine itself might cause health problems, most of the tobacco-induced disorders appear to be due to the carcinogens and carbon mon- Am J Psychiatry 153:10, October 1996 Supplement 51770 6894 3
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stractly, to recall names of common ob- jects, to use correct words to describe rec- ognized objects or to follow simple instructions.  Physical complications of chronic alcohol dependence include cirrhosis (liver dam- age), hepatitis, altered brain-cell function- ing, nerve damage, gastritis (inflammation of the stomach), prema- ture aging, impotence and infertility, and a variety of reproductive disorders. Some researchers suspect the hormonal imbal- ances caused by alcohol dependence actu- ally fool the body into shutting off its supply of natural opiates (endorphins). Chronic alcohol dependence also in- creases the risk and severity of heart dis- ease, pneumonia, tuberculosis and neurological disorders. Among the new techniques for detecting alco- holism is a computerized method of analyzing blood chemistries which could help to identify early-stage alcoholism before the liver is sig- nificantly damaged. Another experimental blood test promises to detect changes in the liver that forecast cirrhosis, an insidious killer that often progresses with no warning until the damage is fatal. Researchers are also discovering other biologi- cal markers that could eventually identify many potential alcoholics. Preliminary studies indicate that alcoholics are born with a faulty liver enzyme system that may lead to their ad- diction, an encouraging twist to the existing knowledge that alcoholics do not metabolize alcohol normally. Still other studies reveal that the majority of alcoholics have abnormal brain waves and memory impairments. This appears to be true of their young children as well, even though the offspring may never have been exposed to alcohol. 5 Alcoholism is generally recognized as a multi- faceted disorder involving psychological, envi- ronmental, biological and cultural factors. and treatment programs for the condition may vary in emphasis. Most programs, however, in- clude a variety of therapies geared toward ab- stinence and designed to approach the illness from all vantage points. Psychotherapy helps patients understand their behavior and motivations, develop higher self- esteem and cope with stress. Because long- term support is considered essential, self-help groups such as Alcoholics Anonymous are often part of a rehabilitation program. Some programs also prescribe daily doses of disulfi- ram (Antabuse), which induces violent physi- cal reactions to alcohol and thus discourages drinking. Drug Use The dramatic increase in illegal drug use over the last 25 years makes it hard for anyone 50 or older to appreciate how extensively the problem has invaded our society. Experience with illegal drugs rose from two percent or less of the population in most areas of the country in the early 1960s to more than a third of the population-70.4 million Ameri- cans-in 1985, according to household sur- veys by the National Institute on Drug Abuse (NIDA). The drugs discussed here include seven major classes: marijuana, cocaine, opiates, hallucino- gens, inhalants, sedative-hypnotics and nico- tine. Not all are physically addictive, but all can lead to psychological addiction, in which the user needs the drug in order to function. Marijuana (Cannabis) Marijuana is the most widespread and fre- quently used illicit drug in the nation. Almost
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\IiOTI\F PF^F\hc\k': dependent smokers would most benefit from nicotine gum. patch. or nasal spray has not been tested i 1 1 3!. Number of cigarettes per dac, presence of significant withdrawal during prior quit attempts. and time to first cigarette have also been proposed as indicators for the use of nicotine replacement therapy, but there are no data on the utilitn• of these indicators. Some have sug- gested that nicotine replacement therapy be used only if the patient is enrolled inbeha%•ior therapy; howe.•er, the data clearly show that nicotine replacement therapy is effective in the absence of behavior therapy isee section IILF.2.c.3 ). In summary, nicotine replacement should be con- sidered in all smokers who have seriously tried to quit on their own and failed [III1. Use of nicotine replace- ment in smokers with cardiovascular disease or who are pregnant is discussed in sections V.B.2. and V.C.3.. re- spectively. Although nicotine gum and patches are available over the counter, psychiatrists still need to be involved in their use by encouraging use when appro- priate, supplementing package instructions, and provid- ing adjunctive psychiatric management and, when ap- propriate, psychosocial and other pharmacological therapies. 2) Pretreatment evaluation. Some have suggested precessation cotinine level is a useful benchmark to ex- amine the percent of nicotine replaced by nicotine medi- cation therapy and thus make decisions on whether higher doses should be used. Whether this improves treatment is controversial (53). 3) Length of treatment. Most treatment optimally lasts 4-6 weeks before tapering [III). Some have advo- cated longer-term use of nicotine replacement therapy and even a nicotine maintenance program. Two pro- spective trials differed in whether longer treatment with nicotine gum produced higher abstinence rates (155. 156). A recent meta-analysis of nicotine patches did not find that longer treatment was associated with higher quit rates (133). 3. Antagonists a. Goals. The goal of antagonist therapy is to prevent cigarettes from producing positive'reinforcing and sub- jective effects. b. Mecamylamine. Mecamylamine is a noncompeti- tive blocker of both central nervous system and periph- eral nicotinic receptors (124, 157, 158) that decreases the positive subjective effects from cigarettes (157, 158). When mecamylamine is given to smokers who are not trying to stop smoking, they initially increase their smoking in an attempt to overcome the blockade pro- duced by mecamylamine (157, 158). Mecamylamine does not precipitate withdrawal in humans, perhaps be- cause it is an indirect blocker (157, 158). Early studies suggested some short-term efficacy with mecamylamine, but the high doses used produced significant dropout rates because of side effects (157, 158). Side effects included abdominal cramps, consti- pation, dry mouth, and headaches. Based on a theory that combined hluckajr an.i acont:: tnrrar% m:_^: :•. beneficial 11?9%. a rtcZnt stuAk :Un1rlnCu itm uo•;• w .:, mecamrlamine and nicotine patch .tnJ rroJU:r.7 J, nificant increase in long-term efticacy with tr%% C!- fects i 160i. Arttagonists have not been ertecmr in orioia ,iru_ dependence because ot compliance prohitm• • I rI. Smokers tend to bz more compliant than opicud .ii`u•- ers; thus. nicotine anta_uni5t• might be rttecnn r. I:t - havioral programs to tnsurr:omrhance >imiLtr n) tho.r used with alcohol and coc.tine dependence might ai.o be helpful I161 i. ]n summar%, mrcamylammr la:i:..ut- ficient evidence to be recommended hut is ;on:idrrr.i promising. c. Aaltrexone. Naltrexone is a long-acting horm uf the opioid antagonist naloxone. The rationale for u:in., naltrexone for smoking cessation is that the pertorm- ance-enhancing and other positive eftects of ni;otinr may be opioid mediated (162). \lost, hut not all. stud- ies have found that naltrexone increases smoking i inter- preted again as an attempt to overcome hlockadet l 1=3. 163). There are no data on naltrexone as acessatum treatment nor on what happens to cigarette use in alco- holics treated with naltrexone. The few side effects from naltrexone include elevated liver enzymes, nausea, and blockade of analgesia from narcotic pain relievers (123). In summarv, at this time, naltrexone lacks suffi- cient evidence to be recommended. 4. Medications that make intakc aversive a. Goal. Nledications in this class produce unpleasant events when the patient ingests the medication. Disulfi- ram treatment for alcoholism (164/ is the most widely known example of this class. b. Silver acetate. This medication combines with sul- fides in tobacco smoke to produce a bad taste. Silver acetate has been tested as a gum and as a pill; neither form has consistentlv been shown to be effective (3, 56, 123,149). In fact, the FDA recently pulled silver acetate from over-the-counter sales because of lack of efficacy (149). As with disulfiram, compliance appears to be quite poor; thus this treatment might he effective if used in conjunction with a behavioral compliance program. The major side effect of concern is argyrism (silver poi- soning), which produces discoloration of skin. This ap- pears to be very rare at the doses used for smoking ces- sation (149). In summary, silver acetate lacks sufficient evidence to be recommended. S. Medications that mimic nicotinic effects a. Clonidine. Clonidine is a postsynaptic a: agonist that dampens sympathetic accivity originating at the lo- cus ceruleus (123, 125, 165). It appears to have some efficacy for alcohol and opioid withdrawal and thus was tried with nicotine withdrawal as well (123, 125). Several clinical trials used oral or transdermal clonidine in doses of 0.1-0.4 mg/day for 2-6 weeks with and without behavior therapy. Three meta-analytic reviews Am J Psychiatry 153:10, October 1996 Supplement 51770 6906 1 S
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62 million Americans had tried marijuana at least once in their lives at the time of a 1985 NIDA survey. Current use (past-month use) had decreased, however, by 1.8 million people. Marijuana is typically used in combination with other substances, particularly alcohol and cocaine. One out of every four young adults who have used marijuana say they usu- ally had an alcoholic drink at the same time. The combination of marijuana and alcohol ac- counted for more than half of the marijuana- related emergency-room cases in 1985. Cigarette smoking by very young children is another pattern strongly related to marijuana smoking. Young people age 15 to 17 who are current cigarette smokers are five times more likely to be current marijuana users. Boys and girls (age 12 to 17) are equally likely to try marijuana, but current users in the 18 to 25 age group are almost one and a half times as likely to be male. Many of the people who have tried marijuana use the drug extensively, and a substantial majority of heavy marijuana users will go on to try other illicit drugs. For example, 74 percent of those who have used marijuana 100 or more times have tried co- caine. The health consequences of marijuana de- pend on the frequency, duration and intensity of use, and the age at which use begins. Mari- juana has the following known and suspected health hazards that merit serious concern:  At commonly used doses, marijuana im- pairs short-term memory, concentration, judgment, information processing, percep- tion and fine motor skills. The risk of acci- dents while driving or operating complex machinery thus increases for those intoxi- cated with marijuana. Even when mari- juana use is discontinued, memory loss may continue for three to six months. Marijuana impairs driving skills for at least four to six hours after smoking a sin- gle cigarette.  Smoking marijuana immediately acceler- ates the heartbeat and, in some individu- als, increases blood pressure, posing a threat to those with abnormal heart and circulatory conditions.  Specific psychiatric concerns include chronic anxiety, symptoms of depression and changes in lifestyle. There is particu- lar concern about long-term developmen- tal effects of marijuana use by children and adolescents. The term "amotivational syndrome" has evolved to describe the changes observed in some marijuana us- ers such as apathy, loss of ambition and effectiveness, diminished ability to carry out long-term plans, difficulty in concen- trating and a decline in school or work performance.  Although human lung cancer has not been linked solely to marijuana smoking, abnormalities suggestive of precancerous lesions have been reported. There are more known carcinogens in marijuana smoke than in cigarette smoke. However, since many marijuana users also smoke cigarettes, the combined carcinogenic ef- fect must be investigated. Marijuana sig- nificantly reduces the capacity of the lungs to exchange gas, even more so than does tobacco.  Marijuana may have serious effects on re- production. Some studies have shown that women who smoked marijuana dur- ing pregnancy gave birth to babies with defects.  In animals, marijuana has been shown to interfere with the body's immune re-
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\1. t•••'\; i.vr: \hl\.; '_0 . l'~, Ucparnmrn; o; Heaitn an,i Humar. ~cnl:es: Tnr Health t`on>caurn.c•, rr .c. _. \.. .. . i. _ .. . 1 i in:. (-on,cuurn.c. u~ 5moian_ For \\ umrr::.a Rrn-rt ot tnr .%urcrun Grnrni. \\asnlncror.. Dl-. L'S C,c,.ernmrn: Prmtnr._ l)itl:c. \\ao::.il..: •.. • L'•>urCrun.,rnc•ra.. l1~ n: c. 1"~• I F ..._ . Ivsu IF! 2ue. brnc,tcrtz \L: Nicotine repiacemen: tnrra,t+% .iurm_ prrenan. . IA\lA 1"41:2oc:;1-a-.I--IF: ?p-. .\aeyc RL: Cu_nmve and i+chavlora: abnnrmallnr> in ;hildren wnusr morhM smoked acarettr> aunnc prrcnan.%. I Drt Br- hav Pedlarr 199?: l.i:4?S-;=;; IG; _OS. Ramirez AG. Galiwn 1:J: \I.onne drrrndrnce amon, hiack> and Hlspan!cs..ln \Iccannr Addictior.: Prtnc:pie> and \lanage- ment. Edlted ht Orirans CT. Slade ID. \rtt York. Oxtord Unr ~:rsrn Pres~. !;'Qa. pp 3 \lL;h4 IF 209. Marsh A. MkF:av S: Poor Smoi:en. Lon,ion. Po6,c Studles In- srrsurc. 19`+4 IF! 210. Howard TS. Huehes (R: Smokinc : ssatlun and the nicotine catch Iletter:. JA\l.a 199.: ?'a:? 14 J6i 211. US Department ot Health and Human Ser.•::es: The Health Consequences of Using Smokeless Tobacco: A Report oi the Adv:son• Committee to the Surgeon Genenal. Washineton. DC. US Government Prinnnc Oftlcr. 1986 IFI 212. US Department of Health and Human Services: Smokeles. Tu- oacco or Health: Smoking and Tobacco Control \lonocraph 2. \C•ashlncton. DC. US Government Prlntlnc Ofncr. 1992 IFj 213. US Department oi Health and Human Services: The Health .. _ \.. h: .. F; 1 r. .... N::V u.er> I l .~n.ta: l 11.^. :! 5. O:i:enr Il.. T^. .i:r......... I' .,..... . I'rc, Tcahta,i, w mir::.rn;:`A^u.: Gaiantr: \1. F:iehc: HI). \\ a.nln_t.,r.. I)s n: Prc•... !114-;. r, !; -;--;F _ Io. henowItz \L: N I;unn; :r.::.trt: tt ~. . ...t. a. a,mrlune.i. C.an .. r.to rct.... _1-. .lanti. ML. s;hnrwrr \~.. \I;t,t:.... .. •::. :al:.. .~~::.. .. wm,t~rehrnsls c Tr.rn„ ,~. 1 alu,:': \Illiman RK. Lar•.eru,'. IL,. haitl:nw::. \\ t;.:a:n. ~\\ :;nln,. 111,4.. PP:0 1F: 218. Anthony JC:. Vi arner L4. i.essler RC: Comparat:.•e eridemtal- oFv of derendcncc on tubaxo. alcohol. cuntrolied sunstana •. and tnhalants: basic findinct from. thr National Cmmorhl,irct Survey. Exp Clin Ps.•ehopharmacol 110,14: 2:244-2ba IC41 219. Fagerstrom K. F:un:e \l. :khuixrinerFer JL. $reslau N. Huche• JR. Hun RD. Puska P. Ramstrom L Zatonsi:i Vi :\tconne dt - pendettce versus prevalence of smukmF: comparisons herw.irn countries and categories of smukers. Tobacco Cemtrul 1Qoi•. 5:52-56 jGj 51770 6922 Am J Psychiatry 153:10, October 1996 Supp/ement 31
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10 Besides addiction, cocaine can lead to serious medical problems:  While users with heart problems or circu- latory disease are at greatest risk of heart attack or heart failure from cocaine and crack, new evidence indicates the drugs can cause heart attacks even in young people with healthy hearts.  Cocaine and crack can also trigger brain seizures, a disturbance in the brain's elec- trical signals, some of which regulate the heart and muscles that control breathing.  The increase in blood pressure caused by the drug may rupture blood vessels in the brain, causing some addicts to suffer strokes.  Psychological effects accompanying the use of cocaine can include violent, erratic or paranoid behavior. This "cocaine psy- chosis" tends to appear sooner in crack smokers. Users are anxious and con- vinced they have superhuman powers, or they may become so suspicious and para- noid that they believe their lives are threatened and react in bizarre ways. Hal- lucinations are also common.  Heavy cocaine users may experience fun- damental personality changes-impaired thinking, confusion, anxiety or depres- sion. Continued use of cocaine and crack can lead to a partial or total break with re- ality.  Miscarriage or stillbirths may result from the use of cocaine or crack during the early months of pregnancy. Use at a later stage may cause premature labor or deliv- ery. Sometimes, when the drug caoses the placenta to separate early, the lives of f i 11 both mother and baby are in danger from shock and bleeding.  Babies exposed to cocaine in the womb may be generally irritable and unrespon- sive, failing to cuddle or nurse well. Some of these babies have suffered strokes be- fore birth or heart attacks following deliv- ery. Infants born to mothers who use cocaine may have malformed kidneys and genitals and may be at increased risk of seizures or crib death (sudden infant death syndrome). Because nursing moth- ers can pass cocaine to their babies through breast milk, babies fed milk con- taining cocaine may be prone to suffer some of the same heart and brain prob- lems as adults. Treatment-Recovery is possible for cocaine and crack users, although the long-lasting craving for these drugs makes addiction diffi- cult to beat without assistance. There are many treatment programs available through- out the country to help people kick their hab- its and stay off cocaine and crack. The first step to treatment is admission by the abuser that he or she has a problem. This is often a major hurdle, for denial is a typical and powerful force with drug abuse. If the abuser resists, it may be necessary for family members to take serious steps on their own behalf as well as that of the loved one. Cocaine users spend vast amounts of money on the drug-whatever it takes to support their habit. As drug use progresses, they may reject all former responsibilities, ignoring bills, selling household possessions, emptying savings accounts, even stealing from friends and family members or turning to embezzling, robbery, drug dealing or prostitution to get cash. Clearly then, the emotional health and stability of the abuser s family are threatened.
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sponse to certain infections and diseases. What significance this may have for hu- mans is still being investigated. Cocaine In 1982, it was estimated that more than 20 million Americans had tried cocaine and more than four million were current users. Current users have increased to almost six mil- lion and the number continues to rise dramati- cally. Moreover, current and frequent users are more likely to report symptoms of depen- dency on the cocaine. What exactly is this seductive substance that has gained such popularity in recent years? Cocaine is a white powder produced from the leaves of the South American coca plant. It is known by a variety of names--coke, C, snow, blow, toot, nose candy and The Lady. Cocaine is a stimulant, a class of drugs that give a tem- porary illusion of limitless power and energy. Most cocaine users in this country snort the powdered drug through the nose, and some dissolve it and inject it into a muscle or vein, to experience the drug's fleeting "highs." Crack is a form of cocaine that is chemically altered so that it can be smoked. It belongs to a category of cocaine known as "freebase," be- cause the processing converts the drug into a chemical base as opposed to an acid or a salt. Smoking allows high doses of cocaine to reach the brain almost instantly. As a result, crack produces the most dramatic cocaine "high " This rapid "high" is followed, however, by a profound "low" that becomes a door to addic- tion. Cocaine is one of the most potent drugs of abuse. It causes chemical changes in the brain that lead to an intense craving for more of the drug. Anyone who tries cocaine or crack risks addiction. Dependency on these drugs is so powerful that they come to rule all aspects of the user's life. Addiction can erode physical and mental health, sap financial resources, ruin careers and drive off family and friends. Users fall into no particular stereotype. Many are well-educated, successful, upwardly mo- bile professionals in their 20s and 30s. But a cocaine user can be anyone-old or young, rich or poor, man or woman. Cocaine abuse and dependence follow one of two patterns of use: episodic and chronic daily, or almost daily, use. Episodic use may occur on weekends, for example, and once or twice during the week. Among users who smoke cocaine or take it intravenously, "binges"-compressed time periods of con- tinuous high-dose use-are common. Binges terminate only when the user collapses from physical exhaustion or the supply of cocaine is depleted. An intense and unpleasant "crash" requiring at least two days of recuperation . generally follows the binge. Chronic daily, or almost daily, use may be at high or low doses, and may occur throughout the day or be only during restricted hours. Although wide fluc- tuations in the amount of cocaine used from day to day are unlikely, doses generally in- crease over time. 'The effects of cocaine on the body are wide- ranging. Immediate effects include increases in blood pressure, heart rate, breathing rate and body temperature; dilated pupils; narrow- ing of blood vessels; loss of appetite and in- somnia. As use progresses, a loss of interest in physical appearance and frequent upper respi- ratory infections may become apparent. Those who snort cocaine may be bothered by a runny nose. As the effects wear off, the in- itial elevation of mood and sense of wellbeing fade into a depression characterized by disap- pointment, dullness and edginess.
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Family members may choose to intervene to help get a cocaine user into treatment. Many professionals recommend a method called a family action plan or intervention. After sev- eral meetings with an experienced drug coun- selor, social worker, psychologist or other health professional, the family confronts the user and each member openly communicates how the user's behavior has affected him or her personally. Other participants in the inter- vention may include friends, employers or co- workers. During the actual confrontation, often led by a professional counselor, family and friends make it clear that the time has come to choose between them and the drug. The inter- vention is designed to catch the addict off guard and to overcome the likely denial. A crucial aspect of the process is presenting the user with treatment alternatives that can be started as soon as the intervention is com- pleted. Detoxification, ridding the body of the drug, is the starting point of any treatment pro- gram. This may be followed by medication, such as antidepressants, which help control the craving and relieve the severe depression that accompanies cocaine or crack withdrawal. Therapy programs also guide the recovering user toward other alternatives to curb craving for the drug. This help may be through a com- bination of individual, group and family coun- seling as well as other techniques aimed at changing behavior. The ultimate goal of recov- ery programs is to improve self-image and pro- mote healthful, drug-free living. Continued strength and support are also found by many recovering individuals by attending meetings of Cocaine Anonymous or Narcotics Anony- mous, self-help groups modeled after the Al- coholics Anonymous program. , Professional support is also available to family members who need help for themselves as they strive to break out of the destructive environ- ment the user's addiction has created. One op- tion is a telephone call to an anonymous service like the nationwide hotline run by the National Institute on Drug Abuse (1-800-662- HELP). Family therapy is often helpful, as is individual support from a trusted friend, fam- ily doctor, clergy member or counselor. Among the support groups formed recently for the families of drug users are Nar-Anon for people whose lives have been affected by a drug abuser, Families Anonymous for families of drug abusers and COCANON groups for those whose lives have been affected by a friend or family member's cocaine habit. These groups have local chapters which are usually listed in the phone book. Opiates Opiates, also referred to as narcotics, are a class of drugs used medically as pain relievers, anesthetics or cough suppressants. Unfortu- nately, as a result of their powerful properties, they have a high potential for abuse. Some opiates come from resin taken from seed pods of the Asian poppy. This group of drugs includes opium, morphine, heroin and codeine. Other opiates such as meperidine (Demerol) are synthetics with morphine-like action. Opium is in the form of dark brown chunks or a powder and is usually smoked or eaten. Her- oin can be a white or brownish powder and is most often dissolved in water and then in- jected. Most street versions of heroin are di- luted, or "cut," with sugar, quinine or other substances to extend the supply and increase profits. Other types of opiates come in the form of tablets, capsules, solutions, syrups and suppositories a+ ~ w m
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residential care settings. Controlled studies of treating nicorme u•irhdra«•al srmptoms on medical or psychiat- ric inpatient wards have not been published: thus, the recommendations below are based on treatrng with- drawal in outpatient settings I 16. 1--. 2. .-Isse:sment a. Il"ithdrauul. Assessment focuses on reports of a history of withdrawal symptoms in prior hospitaliza- tions. s•ithdras-al during-prior voluntarv quit attempts. or significant fear of withdrawal [III). b. Smoking cessation. An inpatient stas. may be an opportune time for initiating treatment for nicotine de- pendence (e.g., because of intensity of exposure to medical staff, diagnosis of medical condition, removal from usual smoking cues). It may therefore be helpful to include smoking cessation on the master treatment plan whenever relevant. Smokers should be assessed for their readinesg and motivation for change as described in section III.C.1. [1) (39). Those considering quitting should be asked about their interest in using the tempo- rary abstinence of the smoke-free unit as the beginning of an attempt to stop smoking permanently [II1]. 3. PsYchiatric management a. System issues. It is very difficult to motivate inpa- tients to stop smoking unless the unit is smoke-free (69, 190); thus, a smoke-free psychiatric unit is recom- mended [I]. Although many inpatient units have been concerned about going smoke-free, the large majority have found it less difficult than anticipated (69, 190). Studies before and after institution of smoke-free units indicate no increases in aggression, disruption, dis- charges against medical advice, use of medications or restraints, or admission refusals (190). One of the most important issues is to prevent psychiatric staff who smoke from either purposefully or inadvertently under- mining smoke-free restrictions. Permitting staff to smoke while on the inpatient unit or in contact with patients may increase the difficuln• for patients who are trying to quit. Giving special off-ward privileges,to allow patients to smoke or labeling off-ward passes as "smoking breaks" implicitly condones smoking (69, 190). In addition, there are risks in allowing the patient smoking breaks; e.g., if the patient has suicidal ideation or a history of eloping or acting out on passes [III]. Policies that pro- vide breaks for both smokers and nonsmokers (on the same schedule) may be preferable to policies that pro- vide smokers with extra passes. Other recommenda- tions for implementing a smoke-free unit are discussed in recent reviews (69, 190). b. Patient education. Patients need to be educated about the rationale for a smoke-free unit; i.e., it is not to force patients to stop smoking but to prevent second- hand smoke exposure to other patients and to be con- sistent with the institution's goal" to encourage healthy behaviors [II] (69, 190). Patients should also be edu- 20 cated about the ,o.1l of rreatmen;::.~.. to r;Ju,:, - drass•al symrtom• and. it patirnt> arc ro i: :r them he;in a.essatuon artemr: ill.. \l.ui, rat:eit:• ar: unaware of the valid syml+mm: or m;on::c s% r;iiarav%.: and their time cewrse: thus. education about thr.r :.tr he helpful (Il1 169, 190% c. ,Uunttorru;. Patient> need to re momitorr,l ror chances in pcychiatrr: symptum:, as wiih.irawal ;an worsen anxiety. insomnia. concentration. and wei;,ht gain and can cause clinicalk si;gniticant incrra.e• in tht, levels of several psychiatric medicanum 11111 itablrN 4 and 5) t2. Si. For example. mam alcoholics smui.e. Thus, during alcohol detoxitication on a:mukc•-rrrc ward, how much of the irritabilit%, anxier%, in•umnra. restlessness, difficultr concentrating, and depression r: due to alcohol versus nicotine withdrawal is un.le ar. Although nicotine..•ithdrawal is thought to be milder. there is substantial between-person variability such that some alcoholic smokers have nicotine .s•ithdrawal symptoms that are more severe than their alcohol wrth- drawal symptoms (191). Similarly, when patients with schizophrenia are hospitalized and given higher Jo.e•s of medications, an.• increases in restlessnesc could he due to nicotine withdrawal rather than neuroleptic-in- duced akathisia. Finally, cessation of smoking can cause dramatic increases in blood levels of some medi- cations; e.g., clozapine levels can increase 40% when smokers are deprived of nicotine (192). 4. Use of psychosocial treatmcats The efficacy of psychosocial treatments for with- drawal symptoms has not been tested (16); however, the clinical experience of the Work Group on Nicotine Dependence suggests several strategies )Ill). Relaxation tapes can be used to alleviate anxiety. Anger can he averted by temporarily avoiding interactions. Insomnia can be decreased by improving sleep hygiene. Weight gain can be combated by increasing activity. Distrac- tion and activities aimed at keeping busy can be used to get through craving episodes. Support groups for those going smoke-free and support from family and signifi- cant others for going smoke-free can he helpful as well. .i. Use o j pharmacological therapies Nicotine withdrawal during hospitalization is often not as severe as anticipated because of the absence of smoking cues, the distraction of the primary problem, the effects of medications, etc. Thus, prophylactic phar- macotherapy should be considered only when patients complain of withdrawal symptoms or if withdrawal signs are observed [1]. Exceptions to this rule would be those patients who are so concerned about nicotine withdrawal that they will not accept hospitalization without treatment for withdrawal. ln this scenario, given the low risk of nicotine replacement, prophylactic treatment with nicotine replacement may have advan- tages over giving extra passes for smoking breaks [I11J. The advantages of nicotine gum include the patient's Am j Psychiatry 153:10, October 1996 Supplement 51770 6911
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51770 6939
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as illegal drugs such as heroin, but does prevent withdrawal and the craving for other opiates. Ircan thus successfully break the cycle of dependence on illegal drugs. Hallucinogens Hallucinogens include such drugs as lysergic acid dyethylamine (LSD), mescaline and pe- yote. These substances are taken orally and can cause the abuser to experience hallucina- tions, perceptions of objects that have no ex- ternal cause. Phencyclidine (PCP) is sometimes referred to as an hallucinogen, al- though it rarely causes hallucinations in the true sense. These drugs came into popular use by young people in the mid-sixties. Since then, how- ever, there has been a steady decline in their use. In 1985, only 3.2 percent of American youths had ever tried hallucinogens compared to 5.2 percent in 1982. Recent users (past-year users) had also decreased from 3.6 percent to 2.6 percent for the same period. Most people are introduced to hallucinogens by experimenting with the drugs in social situ- ations. Some find the hallucinogenic experi- ence extremely vexing or gloomy and lose interest right away, while others enjoy it and continue using the substance. Use almost always occurs in intermittent epi- sodes, because the mind-altering effects of these substances impair cognitive and percep- tual functions to such an extent that the user generally has to set aside time from a daily routine to take the drug. Moreover, the fre- quent user may quickly develop a tolerance for the drug, which makes it virtually impossi- ble to take enough of it on a daily basis to ob- tain the desired effects. For these reasons, abuse is far more common than dependence. Hallucinogens are often contaminated with other drugs such as PCP and amphetamines. In addition, users frequently smoke marijuana and abuse alcohol. The course of use is unpre- dictable, but most people resume their pre- vious lifestyle relatively quickly after a brief period of abuse or dependence. Phencyclidine can be taken orally or intrave- nously, or it can be smoked or inhaled. This substance is sold on the street under a variety of names, the most common of which are PCP, PeaCe Pill and angel dust. PCP is usually taken episodically in binges and "runs" that can last several days. However, some people chronically use the substance on a daily basis. Inhalants Inhalants are breathable chemicals that pro- duce mind-altering vapors. This group of sub- stances includes solvents, aerosols, some anesthetics and other chemicals. Inhalants are not usually thought of as drugs because that's not how most of them were intended to be used. Examples of inhalants are gasoline, glue, paint thinners, nail polish remover and lighter and cleaning fluids. Aerosols used as inha- lants include spray paints, hair sprays and cookware coating agents. Anesthetics include halothane and nitrous oxide, also known as laughing gas. Amyl nitrite and butyl nitrite are other com- monly abused inhalants. Amyl nitrite is a clear, yellowish liquid used for heart patients and for diagnostic purposes because it dilates the blood vessels and speeds up the heart rate. The substance is sold in a cloth-covered, sealed bulb that, when broken, makes a snap- ping sound. Thus the nickname "snappers" or "poppers." Butyl nitrate is packaged in small bottles and sold under such names as "locker
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14 An illegal drug also known as "junk" or "smack," heroin accounts for 90 percent of the opiate abuse_in the United States, accord- ing to National Institute on Drug Abuse f•ig. ures. An estimated half a million Americans are addicted to heroin. Other opiates used for legal medicinal purposes may also be abused. These include morphine, meperidine, parego. ric (which contains opium) and cough syrups containing codeine. About half of those who abuse opiates de- velop a dependence or addiction. When some- one becomes dependent, obtaining and using the drug become the main focus in life to the exclusion of all else. As the drug is increased over time, greater amounts are needed to achieve the same effects. This tolerance can reach remarkably high levels. Opiates generally relax the user. When they are injected, the person experiences an itnme- diate "rush." Other initial adverse effects ira- clude nausea, vomiting and restlessness. The user may alternate between feeling alert and drowsy. In the case of extremely large doses, the user can't be awakened, pupils become smaller and the skin becomes cold, damp and bluish. Breathing slows down and death may occur. Opiate withdrawal symptoms usually begin within four to six hours of when a dependent user stops taking the drug. These symptoms include nausea, diarrhea, abdominal cramps, chills, sweating, uneasiness and runny nose and eyes. The intensity of the symptoms de- pends on the dose, how often the drug was taken and for how long. For most opiates, withdrawal symptoms are stronger about 24 to 72 hours after they start and subside within a week to 10 days. Symptoms like insomnia and craving for the drug can last for months. 1 15 Stost of the dangers of opiate abuse are asso- ciated with the use of unsterile needles, con- taminadon of the drug itself, or mixing the drug with other substances. Eventually, opiate users may develop infections of the heart lin- ing and valves, congested lungs and skin ab- scesses. Infections from unsterile solutions, syringes and needles can lead to acquired im- munodeficiency syndrome (AIDS), liver dis- ease, tetanus and serum hepatitis. Scientists estimate that nearly half the women who are dependent on opiates suffer heart dis- ease, anemia, diabetes, pneumonia or hepati- tis during pregnancy and childbirth. These women have more spontaneous abortions, premature births, stillbirths, breech deliveries and caesarean sections. And their babies often have withdrawal symptoms that may last several weeks or months. Many of these in- fants die. Treatment is available for opiate addiction. Most programs offer one of four basic ap- proaches:  Detoxification in a hospital or as an out- patient. This involves supervised with- drawal from drug dependence, either with or without medication.  Therapeutic communities where patients live in a highly structured, drug-free envi- ronment and are encouraged to help themselves.  Outpatient drug-free programs which em- phasize various forms of counseling as the main treatment.  Methadone maintenance, which uses methadone, a substitute for heroin, daily to help people lead productive lives while still in treatment. A synthetic drug, metha- done does not produce the same "high"
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2s American Modical Ssxiety on Alcoholism and Other Drug Dependencies 6525 West North Avenue, #204 Oak Park, Illinois 60302 (312) 848-6050 American Society of Addiction Medicine 5225 Wisconsin Avenue, N.W., Suite 409 Washington, D.C. 20015 (202)244-8948 Association for Medical Education and Research in Substance Abuse Brown University, Box G Providence, Rhode Island 02912 (401) 863-1109 Committee on Problems of Drug Dependence, Inc. 3420 N. Broad Street Philadelphia, Pennsylvania 19140 (215) 221-3298 Drug Abuse Information and Treatment Referral Line 1-800-662-HELP Spanish 1-800-66-AYUDA National Association of State Alcohol and Drug Abuse Directors 444 North Capitol Street, N.W, Suite 642 Washington, D.C. 20002 (202) 783-6868 National Clearinghouse for Alcohol and Drug Information PO Box 2345 Rockville, Maryland 20847-2345 (301) 468-2600 1-800-729-6686 National Council on Alcoholism and Drug Dependence 12 West 21st Street, 7th. Floor New York, NY 10010 (212) 206-6770 National Federation of Parents for Drug-Free Youth 8730 Georgia Avenue, Suite 200 Silver Spring, Maryland 20910 1-800-554-KIDS 27 National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-105 Rockville, Maryland 20857 (301)443-3885 National Institute on Drug Abuse 5600 Fishers Lane, Room 10-05 Rockville, Maryland 20587 (301)443-6480 National Self-Help Clearinghouse 25 West 43rd. Street, Room 620 New York, NY 10036 (212) 354-8525 Online ReBource8 Visit the American Psychiatric Association's site on the World Wide Web. http:/Avww.psych.org The text of this pamphlet is available in electronic format on the APAs Web site. http://www.psych.org/public info! sub ab l.htatl
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room" and "rush." It produces a high lasting from a few seconds to several minutes. Young people between the ages of seven and 17 are the most common abusers of inhalants. About nine percent of young people in this country had experimented with inhalants in 1985, while only four percent were current users. These youths generally come from back- grounds reflecting family instability-separa- tion, lack of supervision, alcohol or other drug dependence. School or work adjustment prob- lems such as delinquency, truancy, poor grades, dropping out of school and unemploy- ment are also common. Occasionally, young children misuse inhalant products uninten- tionally, since they are often found around the house. Inhalants reach the lungs and bloodstream very quickly. They work in much the same way as anesthetics, which slow down the body's functions. Low doses can cause a feeling of slight stimulation; more of the substance may lead to reduced inhibitions and less control. At high doses, loss of consciousness can occur. The immediate effects of inhalants include nausea, nosebleeds, coughing, sneezing, feel- ing and looking tired, bad breath, lack of coor- dination and loss of appetite. Solvents and aerosols also decrease heart and breathing rates and affect judgment. The degree of these effects varies with the specific substance inhaled, the dose, and the personality and ex- perience of the user. More serious effects can result from deep breathing of inhalant vapors, or using large quantities over a short period of time. These effects may include loss of self control, violent behavior, losing touch with one's surround- ings, unconsciousness or death. Nausea and vomiting may also occur, and if the user is un- conscious while vomiting, death from aspira- tion can result. Sniffing high concentrations of inhalant fumes can produce heart failure and instant death. Such concentrations cause death from suffoca- tion by displacing the oxygen in the lungs. In- halants can also depress the central nervous system to the point that breathing slows down until it stops. Long-term abuse of inhalants can cause fa- tigue, weight loss, electrolyte (salt) imbalance and muscle fatigue. Repeated sniffing of con- centrated vapors over several years can dam- age the liver, kidneys, blood and bone marrow, and can also lead to permanent dam- age to the nervous system, causing major physical and mental deficits. Sedative-Hypnotics - Sedative-hypnotics are a group of drugs re- ferred to as tranquilizers and sleeping pills, or generally as sedatives. These drugs are used medically to relieve anxiety and promote sleep. When they are abused or taken at high doses, however, many of these drugs can lead to unconsciousness and death. Although the nonmedical use of sedatives among the 18-to-25 age group declined from 8.7 percent in 1982 to 5.1 percent in 1985, use of tranquilizers and analgesics (pain relievers) by older adults increased from 1.1 percent in 1982 to 2.8 percent in 1985. The two major categories of sedative-hypnot- ics are barbiturates-also known as "barbs" and "downers"-and benzodiazepines. All of the drugs in these groups have similar chemi- cal structures. Some commonly abused barbi- turates include amobarbital (Amytal), secobarbital (Seconal) and pentobarbital
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20 (Nembutal). Diazepam (Valium), chlordiaze- poxide (Librium) and chlorazepate (Tranxene.) are examples of benzodiazepines. Several sedative-hypnotics fall into a separate category. They include methaqualone (Quaa- lude, Sopor), ethchlorvynol (Placidyl), chloral hydrate (Noctec) and meprobamate (Mil- town). All of these drugs can be extremely dangerous when not taken according to a physician's in- structions. They can cause both physical and psychological dependence, and regular use over a long period of time may lead to toler- ance. Withdrawal symptoms are also likely to occur when regular users suddenly stop taking large doses of these drugs. These symptoms can range from restlessness, insomnia and anxiety to convulsions and death. Large doses of barbiturates can cause uncon- sciousness and death. With barbiturates, there is less difference than with other sedatives be- tween the amount that produces sleep and the amount that kills. Barbiturate overdose is a factor in close to one-third of all reported drug-related deaths, including suicides and ac- cidental drug poisonings. When barbiturates are abused, their effects are similar to the effects of alcohol. Small doses produce calmness and relax muscles. Slightly larger amounts can cause poor judg- ment, slurred speech, staggering gait and slow, uncertain reflexes. It is easy to see why driving a car or operating machinery become very dangerous if one abuses these drugs. Combining sedative-hypnotics with alcohol is especially dangerous. The use of these drugs with alcohol and other drugs that slow down body functions multiplies their effects and greatly increases the risk of death. Overdose deaths can result-whether deliberate or acci- 21 dental-when barbiturates and alcohol are combined. Women who abuse sedatives during preg- nancy may give birth to babies who are physi- cally dependent on the drugs and show withdrawal symptoms shortly after birth. Many sedatives pass easily through the pla- centa and are known to cause birth defects and behavior problems in the offspring of women who abuse these drugs while pregnant. Nicotina After years of controversy over the dangers of smoking, the latest report by the U.S. Surgeon General has confirmed that nicotine in to- bacco products is an addictive drug compara- ble to heroin or morphine. The report showed a 37 percent decrease in smoking from 1975 to 1985. While this de- cline is certainly encouraging news, the fact re- mains that close to 50 million Americans still smoke cigarettes. And 320,000 deaths a year in this country are the result of tobacco prod- ucts. The prevalence of smoking among males con- tinues to be greater than that among females (29.5 percent for men; 23.8 percent for women), and figures remain higher for black smokers than for whites (28.4 percent for blacks; 26.4 percent for whites) Anyone who has smoked regularly can attest to the difficulty in giving up the habit. Most people try repeatedly to give up smoking with- out success. Studies suggest that the relapse rate is greater than 50 percent in the first six months, and at least 70 percent in the first year. After a year of abstinence, however, sub- sequent relapse is far less likely.
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22 The most common form of nicotine depen- dence is linked to the inhalation of cigarette smoke. The nicotine effects of cigarette smok- ing have a more rapid onset than with pipe and cigar smoking, tobacco chewing and the use of snuff. The habit pattern is more inten- sive and difficult to break due to frequent re- inforcement and greater physical dependence on the nicotine. The unpleasantness of withdrawal may add to the difficulty of giving up smoking. The nico- tine withdrawal syndrome includes craving for the drug, irritability, frustration or anger, anxi- ety, difficulty concentrating, weight gain or de- creased heart rate or appetite. Environmental cues such as the presence of other smokers and the widespread availability of cigarettes also surround the smoker with temptations. Evidence that nicotine is addictive has re- sulted from studies of the drug's effects on the brain and other parts of the body. Nicotine acts on specific receptors in the brain and other parts of the nervous system. It also re- laxes skeletal muscles and affects the heart, blood vessels and hormonal system. Smokers become addicted to the mood-alter- ing, stress-reducing properties of nicotine. Their performance has been shown to im- prove on some cognitive tests after smoking a cigarette, even on tests requiring sustained at- tention. And the drug also apparently helps to suppress appetite. Some smokers muster the determination and willpower to quit on their own. For others, the various stop-smoking programs offered by health care agencies, employers and various private groups around the country have been the answer. If we are to maintain momentum toward the goal of a smoker-free society, the Centers for 23 Disease Control recommends that govern- ment agencies, private organizations, health- care providers and others must work together to support programs and policies that encour- age non-smoking behavior. Possible steps to- ward the realization of this goal include the following:  Offer smoking prevention and cessation programs in schools, worksites, health- care facilities and other institutions.  Ban or restrict smoking in public places and worksites.ep  Restrict the sale of tobacco products to minors.  Ban all tobacco advertising. Provide reduced premiums for health and life insurance to nonsmokers.ep  Provide third-party reimbursement for smoking cessation programs.ep  Raise the cigarette excise tax. Hibliography General Information Bartimole, Carmella and John. TeenageAlcol:olism and SubstanctAbuse. Hollywood, Florida: Compact Books,1986. Chatlos. Calvin. Crack New York: Putnam, 1987. Cigarette Smoking in tke Unued Stare4 1986. U.S. Department of Health and Human Services, Centers for Disease Control, Morbidity and Mortality Weekly Report, %61. 36, No. 35. Atlanta, Georgia: Centers for Disease Control, September 11,1987. Cocaint/Crack' T1:e Big Lie. U.S. Department of Health and Human Services, National Institute on
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NICOTI\E DEPENDENCE quire several anemFts before they succeed :_'-r, thtu. anN success {atrr in the al_ortthm cannot be artnh- ured to the specific treatment being _iven at that point. 21 Eariv cessation of smoking can Prevent much of the - devastating consequences of smoking t 1 b r thus. dela% tno deGvertn, a treatment known to he effective could allo.v a serious, irreversible consequence of smoking ie.;.i an acute mvocardial infarctioni to occur. 3t The notion that most smokers can quit on their own or will need only minimal rreai:ment is based on research on smokers Without a history of psychiatric problems t?-t. Smokers with psychiatric problems appear to he 2-3 times less likely to successfully stop smoking than smokers without psychiatric problems l?. 8. 331; thus. psychiatric patients require more intensive interven- tions earlier on 1111. c. Trntirrg. It may he helpful to have smoking cessa- tion listed as a goal on the master treatment plan for smokers 111. V"hen and how cessation advice is best delivered must be determined by the patient's status; e.g.. smoking cessation is not likely to be successtul when the patient is in crisis (1111. The best time for ces- sation would appear to be when the patient is psychia- tricaliv stahle, there are no recent or planned changes in medications, and no urgent problems take prece- dence 11111. d. A9orritoring. Cessation appears to exacerbate psy- chiatric symptoms. and these symptoms undermine smoking cessation in a small subset of patients (2): thus, patients with a present or past psychiatric history are contacted optimally 2-3 days postcessation and often thereafter to assess mood, problems. etc. 1111. The blood levels of many psychiatric medications increase suh- stantiallv when patients taking such medications stop smoking, and these increases could worsen side effects or cause toxicity (table 5) (8); thus, blood levels and medication side effects should he monitored 1111. 4. Use of psychosocial treatments Although brief interventions, self-help, and suppor- tive therapy have been shown to he effective with Fen- eral medical patients, such minimal therapies may not be sufficient in patients with psechiatric problems. in addition, psychiatric patients often have fewer social supports, coping skills, etc. These two considerations suggest behavioral therapy should be considered even in the early quit attempts for these patients (11(. Since many psychiatric patients have experience with individ- ual or group therapy, patient preferences should be con- sidered in choosing between the two (111(. If the patient has specific problems that undermine cessation (e.g., problems with assertiveness), the therapist might work on this issue in individual therapy.vhile the patient con- tinues a group therapy 11111. .i. Use of pharmacotherapy Since psychiatric patients appear to have more with- drawal symptomatology when they stop smoking (2), usr uf nt.ourne reria:emrnr tn;ra^•• .~:.. .. ...- ~., tion attempt> iN rr:ornmcnar.: ' 11 ;::a: „.... ancr with nicotine cum t•.ittri;ui; spray ha, abuse p:xrnnai . 13 ..tn,: ;ioni.itn; a.i• r.. quent side eftecr> : It+i:, the ni;omnr rat;i: i• mrnded as the usual tnttt.il l+harma;uthrr,tp: :I .:\ - thou,h many psychiatric patients :mukr iar_r numrrr• of cicarettes and inhale ctcarrrte >mokr drrpk •~. u- in, higher-than-normal do.r :it ni;omn; tn,r h;.t:l,: smokers has not ccma:trntlv hrrn :itown nuirr rtrc:tt.: (;.ii. However. sul+plrmrntatu,n:,r ni:otinr patch wit:~ ad-lih use of niccninr ;_um al+l+rar• ro hrip ,r.mrnt• m r- the rough time> and :hould be c:m.i.irrr.l I 11; , I 1 U% Those patients who smoke tr%%rr than 13 ;i_arrttr• per day are candidates for starting with an intrrmr.h- ate rather than high-dose patch or for uan, nm;otmr gum instead 1111 11' 511. Whether the 24- or Ia-houtr patch is better is debatable t I.; I:. Tweno -tour- hour patches may better relir%r morning craving hut appear to cause insomnia 1131. I3_' :. l.on~"rr .luratlnn• of patch therapy have nor been tound nu0rr cttr:nnr (133); thus. a 6- to 12-week duration (it therapy ts rr.- ommended 111(. If the patient has a preference for ni:utinr gum, then the gum is best used with scheduled dosing le.g.. I pircr of gum/hour) rather than ad-lib dosin;, and the 4-mg dose is recommended for heavy smokers imorr than -' 5 cigarettes/day 1 or more nicotinr-deprndrnt smokers I II I (143, 184, 1 S5). In any of the situations in which nico- tine gum is usrd, strong encuur.tgrmrnt to comply with use recommendations is necessary (11(. The optimal du- ration of nicotine gum therapy is debatable (1131. Clini calh•, some patients appear to require long durations ot treatment: i.e., 6 months or Ion;,rr. Given the lack ut medical harm from nicotinc };um and that almost all smokers eventually stop using the gum (41), patient preference for duration of gum use should he the ma- jtrr determinant for duration of treatment 11111. Some clinicians have suggested that some smokers will need nicotine maintenance for life. Given the absence of em- pirical data on this, proactivr encouragement of main- renance is not recommended. If the patient has a strong objection to nicotine re- placement therapy, clrmidine mav hr used IIlI• Cloni- dine delivered via patch therapy may improve compli- ance. Usually 0.1-0.4 mg of clonidine per day is needed (11l (1?j, 16i). !f this therapy is used, interactions of clonidine side effects le.g., sedation) with psychiatric status should he monitored IIII (165). Among patients with a past history of a psychiatric disorder hut who are no longer taking psychiatric medications or in active psychotherapy, restarting psy- chiatric medications or psychotherapy prior to cessa- tion may dampen withdrawal problems and prevent remission of the psychiatric illness (2. 167). Although the efficacy of this strategy has not been tested, if the patient or physician believes psychiatric symptomatol- ogy has precipitated relapses in prior cessation at- tempts, reinstitution of psychiatric treatment should be considered (2). 18 Am J Psychiat ry l 53: 10, October 1996 Supplement 51770 6909
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EZ69 0LLti5
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4 stractly, to recall names of common ob- jects, to use correct words to describe rec- ognized objects or to follow simple instructions.  Physical complications of chronic alcohol dependence include cirrhosis (liver dam- age), hepatitis, altered brain-cell function- ing, nerve damage, gastritis (inflammation of the stomach), prema- ture aging, impotence and infertility, and a variety of reproductive disorders. Some researchers suspect the hormonal imbal- ances caused by alcohol dependence actu- ally fool the body into shutting off its supply of natural opiates (endorphins). Chronic alcohol dependence also in- creases the risk and severity of heart dis- ease, pneumonia, tuberculosis and neurological disorders. Among the new techniques for detecting alco- holism is a computerized method of analyzing blood chemistries which could help to identify early-stage alcoholism before the liver is sig- nificantly damaged. Another experimental blood test promises to detect changes in the liver that forecast cirrhosis, an insidious killer that often progresses with no warning until the damage is fatal. Researchers are also discovering other biologi- cal markers that could eventually identify many potential alcoholics. Preliminary studies indicate that alcoholics are born with a faulty liver enzyme system that may lead to their ad- diction, an encouraging twist to the existing knowledge that alcoholics do not metabolize alcohol normally. Still other studies reveal that the majority of alcoholics have abnormal brain waves and memory impairments. This appears to be true of their young children as well, even though the offspring may never have been exposed to alcohol. Alcoholism is generally recognized as a multi- faceted disorder involving psychological, envi- ronmental, biological and cultural factors. and treatment programs for the condition may vary in emphasis. Most programs, however, in- clude a variety of therapies geared toward ab- stinence and designed to approach the illness from all vantage points. Psychotherapy helps patients understand their behavior and motivations, develop higher self- esteem and cope with stress. Because long- term support is considered essential, self-help groups such as Alcoholics Anonymous are often part of a rehabilitation program. Some programs also prescribe daily doses of disulfi- ram (Antabuse), which induces violent physi- cal reactions to alcohol and thus discourages drinking. Drug Use The dramatic increase in illegal drug use over the last 25 years makes it hard for anyone 50 or older to appreciate how extensively the problem has invaded our society. Experience with illegal drugs rose from two percent or less of the population in most areas of the country in the early 1960s to more than a third of the population-70.4 million Ameri- cans-in 1985, according to household sur- veys by the National Institute on Drug Abuse (NIDA). The drugs discussed here include seven major classes: marijuana, cocaine, opiates, hallucino- gens, inhalants, sedative-hypnotics and nico- tine. Not all are physically addictive, but all can lead to psychological addiction, in which the user needs the drug in order to function. Marijuana (Cannabis) Marijuana is the most widespread and fre- quently used illicit drug in the nation. Almost
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Nh. .`TI\; D'cCF\: nioues are as eftective as rapid smoking is debatable : 5 1, -1. -_' . --3. 9 2 :. Although most therapists no longer use rapid smok- in, because of health and compliance concerns. rapid smoking appears to be safe in healthy patients t5 1. -1, ''_, -4 t and those with medical disorders may be able to participate with medical supervision 1111. In summan•, rapid smoking is a recommended component of behavior therapy for those-smokiers willing to comply (III. 4/ Social support. Although many studies indicate social support for stopping smoking is a predictor of cessation• attempts to harness social support as an in- tervention have been mostly unsuccessful 15 1, -_', 74). Buddy systems, increasing cohesion in group therapy, and teaching spouses to reinforce not smoking have not consistently increased quit rates (3. 51, 72. 74). The lack of success of such interventions is likely related to their failure to influence the level of support. A recent study that.vas successful in enhancing levels of social support did enhance smoking cessation outcome (941. Most cli- nicians and programs address social support because lack of social support appears to undermine cessation attempts (95). In summary, social support lacks suffi- cient evidence to be recommended but is a promising treatment. S) Contingency management. In this procedure, smokers are either reinforced for not smoking with the presentation of some reward or punished for smoking by the loss of some reward. For example, patients place a deposit that is either refunded contingent on not smoking or forfeited for smoking, using carbon mon- oxide level as an objective measure of smoking. Contin- gency contracting is effective.vhile the contingency is in place, but whether this effect persists after the contin- gency is removed is unclear (51, 72, 74). Thus tar, pro- cedures to wean smokers from such contingency proce- dures have not been developed. Meta-analysis of long-term studies does nor support the efficac}• of con- tingenc}' contracting with smoking (3). In summary, contingency contracting lacks sufficient evidence to be recommended. 6) Cue exposure. Cue exposure involves repeat- edly exposing patients to real or imagined situations that evoke potent urges to smoke in an attempt to ex- tinguish the ability of these situations to evoke urges to smoke. Four randomized, controlled trials of cue expo- sure have been published (96-99), and meta-analysis does not support the efficacy of cue exposure (3). In summary, cue exposure lacks sufficient evidence to be recommended. 7) Nicotine fading. In this procedure, patients gradually reduce the nicotine yield of their cigarette. This technique should not be confused with reducing the number of cigarettes per day, which was covered in section III.D.6. With nicotine fading, some smokers in- crease the number of cigarettes or smoke each cigarette more intensely, but overall nicotine consumption is sig- nificantly reduced (51, 71, 72, 74, 90). The evidence that this treatment increases quit rates is mixed (51, 71, 72, 90), and meta-analyses do not support its efficacy ia, i6:. In summ.tn, dence to he recommrndr.i. S, Rc1a.rJtrc>r:. RelaxatuYn i• omcr, tau_n: r,• .:.zr age relapse siruation: zsso:iatr.i xvitii anxirr%.Aiuioi:_° ohen used in mulncompcment l+ro;r.tm>, reia%.it:or. :: selt usually ha> not been shown rt, incrra:c cessation t51. -1, -_. -;, a0:% and mrta-inal%.i. ,itl;• nor support its efticac% :3% In :ummar., rrl.t\ation lacks sufficient evidence m be rr.ommrn.ir.i. 91 Phr:uoluti,al The ratuonair n,r tiil, procedure is that giving pattrnt7~ mtme.ii.ttc .tn,: crete positive feedback ot the hrnctit. (ii 1101 :m04.1n, by showing them that their carbon momom,ir ic•%c•l dr- clines with cessation will reinforce not smoking. l:cm- trolled trials of the efficacy or such teedha;k ha% r pro- duced mixed results 155, 56), and the one meta-anah-.i> did not support its efficacy i 3). Thus. physiological cer,i- back lacks sufficient evidrnce to he rrcommenJe.1. c. ImplenicntJtiwr. Both group and individual for- mats have been used for behavioral therapies for :mul.- ing cessation (S'. SS, --li. Group.s arc otten used to increase social support tor stopping smaking, and in- dividual therapy is used to. tailor treatment to the spe- cific problems of the individual smoker. Meta-analv.e> suggest little difference in outcomes across group vrr- sus individual therapy t3. 5-. SS). Thus, patient pref- erences and availability of specific treatments should be considered when recommending group versus indi- vidual therapy (I11J. Since tnvo-thirds of patients relapse in the first week (13, 86), most treatment is optimalh• timed before or very soon after cessation 111. In most cessation prc+- grams, several sessions occut over the few weeks imme- diareh• prior to and immediately after the quit darr 1-4 ). The most common providers of behavior therapy are voluntary organizations {e.g., the American Lung As- sociation), wellness programs, or health educatetrs/ psychologists in health care organizations (100). A ma- jor problem is that, although clearly effective, behavior therapy is often not available to patients or available only intermittently, is costlv, and is not integrated into the health care system (60, 100, 101). As a result, man.• of those motivated to quit forego behavior ther- ap.• (60, 101) Although recent studies of matching particular be- havior therapies to particular types of smokers have been published (102, 103), at present there are insuffi- cient data to recommend specific matching strategies. Psychiatric patients, including those with substance abuse/dependence, are more likely to benefit from be- havior therapy because of their high incidence of psy- chosocial problems, poor coping skills and, often, past history of benefit from such therapy (68). 2. Self-help materials The major goals of self-help materials are to increase motivation and impart cessation skills. Written manu- als are the most common form of self-help material, al- though recently computer and video versions have been Am J Psychiatry 153:10, October 1996 Supplement 51770 6902 11
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10 Besides addiction, cocaine can lead to serious medical problems:  While users with heart problems or circu- latory disease are at greatest risk of heart attack or heart failure from cocaine and crack, new evidence indicates the drugs can cause heart attacks even in young people with healthy hearts.  Cocaine and crack can also trigger brain seizures, a disturbance in the brain's elec- trical signals, some of which regulate the heart and muscles that control breathing.  The increase in blood pressure caused by the drug may rupture blood vessels in the brain, causing some addicts to suffer strokes.  Psychological effects accompanying the use of cocaine can include violent, erratic or paranoid behavior. This "cocaine psy- chosis" tends to appear sooner in crack smokers. Users are anxious and con- vinced they have superhuman powers, or they may become so suspicious and para- noid that they believe their lives are threatened and react in bizarre ways. Hal- lucinations are also common.  Heavy cocaine users may experience fun- damental personality changes-impaired thinking, confusion, anxiety or depres- sion. Continued use of cocaine and crack can lead to a partial or total break with re- ality.  Miscarriage or stillbirths may result from the use of cocaine or crack during the early months of pregnancy. Use at a later stage may cause premature labor or deliv- ery. Sometimes, when the drug causes the placenta to separate early, the lives of 11 both mother and baby are in danger from shock and bleeding.  Babies exposed to cocaine in the womb may be generally irritable and unrespon- sive, failing to cuddle or nurse well. Some of these babies have suffered strokes be- fore birth or heart attacks following deliv- ery. Infants born to mothers who use cocaine may have malformed kidneys and genitals and may be at increased risk of seizures or crib death (sudden infant death syndrome). Because nursing moth- ers can pass cocaine to their babies through breast milk, babies fed milk con- taining cocaine may be prone to suffer some of the same heart and brain prob- lems as adults. Treatment-Recovery is possible for cocaine and crack users, although the long-lasting craving for these drugs makes addiction diffi- cult to beat without assistance. There are many treatment programs available through- out the country to help people kick their hab- its and stay off cocaine and crack. The first step to treatment is admission by the abuser that he or she has a problem. This is often a major hurdle, for denial is a typical and powerful force with drug abuse. If the abuser resists, it may be necessary for family members to take serious steps on their own behalf as well as that of the loved one. Cocaine users spend vast amounts of money on the drug-whatever it takes to support their habit. As drug use progresses, they may reject all former responsibilities, ignoring bills, selling household possessions, emptying savings accounts, even stealing from friends and family members or turning to embezzling, robbery, drug dealing or prostitution to get cash. Clearly then, the emotional health and stability of the abuser s family are threatened.
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24 Drug Abuse Publication No. 87-1427. Washington, DC: Superintendent of Documents, U.S. Government Piintitig Office, 1987. Daley, Dennis C. ScuvivingAddictions. New York: Gardner Press, 1987. Franks, Lucinda "A New Attack on Alcoholism." New York Times Maga_ine, October 20,1985, pp. 47-67. High.lights of the 1985 National Household Survey on Dn,tgAbure. U.S. Department of Health and Human Services, National Institute on Drug Abuse, NIDA Capsules. Rockville, Maryland: Press Office of the National Institute on Drug Abuse, 1986. Inhalanu. U.S. Department of Health and Human Services, National Institute on Drug Abuse Publication No. 83-1307. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1983. Ketcham, Kathy and Ann Mueller. Recover. New York: Bantam Books, 1987. Marijuana. U.S. Department of Health and Human Services, National Institute on Drug Abuse, NIDA Capsules. Rockville, Maryland: Press Office of the National Institute on Drug Abuse, 1986. Marlin, Emily. Hope. New York: Harper & Row, 1987. Myers, Judy. Staving Sober New York: Congdon & Weed, 1987. O'Gorman, Patricia A. and Philip Oliver-Diaz Breaking the Cycle ofAddiction. Pompano Beach, Florida: Health Communications, 1987. Opiates. U.S. Department of Health and Human Services, National Institute on DrugAbuse, Publication No. 84-1308. Vliashington, DC: Superintendent of Documents, US. Government Printing Office, 1984. Perez,.Joseph F. RelationsF.ips. New York: Gardner Press, 1987. Position Statement on Psychoactive Substance Use and Dependence: Update on Marijuana and Cocaine. Washington, DC: American Psychiatric Association, 1987. 25 Russell, George K.Marijuana Today.•A Compilation of Medical Findings for the Layman. New York: Myrin Institute for Adult Education, 1978. Sedative-Hypnotics. U.S. Department of Health and Human Services, National Institute on Drug Abuse, Publication No. 84-1309. Washington, DC: Superintendent of Documents, U.S. Government Office of Printing,1984. Spickard, Anderson and Barbara R. Thompson. Dying for a Drtnk Waco, Texas: World Books, 1985. Wl:en CocaineAjfects Someone You Love. U.S. Department of Health and Human Services, National Institute on Drug Abuse, Publication No. 88-1559. VVathington, DC: Superintendent of Documents, U.S. Government Printing Office. 1987. Other Resources Alcohol and Drug Abuse Problems Association of America, Inc. 444 North Capitol Street, N.VN., Suite 181 Washington, DC 20001 (202) 737-4340 Alcohol, Drug Abuse, and Mental Health Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 443-3783 American Academy of Child and Adolescent Psychiatry 3615 Wisconsin Avenue, N.W. Washington,D.C. 20016 (202) 966-7300 American Academy of Psychiatrists in Alcoholism and Addictions PO Box 376 Greenbelt, Maryland 20770 (301) 220-0951 American Council on Drug Education 136 East 64th. Street New York, NY 10021 1-800-488-DRUG
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....LJ:.. ..~ pression. difficulty ccmcentrinn_, and inse,mnia seen in patients \\•ich schizophrenis 1 ser section I\'.C. ~... 4. Othcr• n;rcbtatrtc .7r5r,r,7cr: There is insufficient intormation to make specific rec- ommendations about railorin: treatment of smokin, cessation to the needs of smokers.\•ith other psychiatric disorders. In general. when psychiatric patients make an attempt at smoking cessation. they should he tol- lrn\•ed closely to tnbmto-f for more se\•ere nicotine with- dra\\•al, exacerbation of their psychiatric disorder. and possible side effects due to cessation-induced increases in medication levels 11111 (8). Ptnrnr<erthrr.lt rl,ik to.* l- \\::.i\. :., .. vascular drsea•r should h;: ma.i. c::rv: increase their mtlrr\•JtNtn tt, aol` smi+i:mL. ;lI:: I Tn. risk: or cardic\\ i>cular di.ea>r.lr:rea.r mar1%v,1i\ ir n:, trrst %rir attrr cmokrng cessation an.iJ arr nr.i- by c\-rar. I+cr:tcr>;anom -I a- .= >aol+pm, I+c~:r m\~~;ar.iral-rntar;t~,~: also suhstanti.tll\ rncre,i.rs survival i lQ-j. 3, Stopping >muicrn; i, ntu;i: mor, imt portznt than ch.tngrn~ dret. wc•i_h:% or c•\er:r,c . I w' . Thr one anecdotal oh:rr\ancm cit heart atra;i.• ring while usrtr_ mcemne p.u.hr• ha• been rrtutc•d i•\ empirical studies that show that thc nr:unnc r.tt;ii i• safe in patients with stable cardiac .iura.c• i ly31:. B. CONCURRENT GENERAL MEDICAL DISORDERS 1. Gertcral nrauagcmcrtt Often, psychiatrists are asked to see general medical patients in consultation. In addition, many psychiatric patients who smoke have smoking-induced medical ill- nesses. In fact, the onset or diagnosis of a smokinR-re- lated medical illness provides an opportunity for moti- vating the patient to make a quit attempt ('3 ). Smokers who have recently been diagnosed with a tohacco-re- lated illness (e.g., a heart attack) have a substantially greater success rate at smoking cessation (-3). Since many of these patients will quit on their own without treatment (73), a stepped-care approach is appropriate with these patients 11111 (48). In this approach, patients are given minimal therapies initially unless there are particular reasons to use more intense interventions current active alcohol dependence). With this ap- proach, the clinician needs to follow these high-risk pa- tients closel\• to initiate treatment promptly because many patients will relapse after minimal treatment III (48, %3). If minimal treatment fails, a more intensive treatment should be tried. If the patient is hospitalized for a medical problem when he or she decides to stop smokin,,, withdrawal mav not be a problem while the patient is in the hospi- tal; thus, nicotine replacement therapy may not he nec- essary 11111 (48, 73). However, many patients find that withdrawal symptoms occur upon return to their natu- ral environs ( l 6); thus, these patients should he fol- lowed very closely after discharge to determine whether nicotine replacement therapy is indicated II I. In patients with general medical problems, it is impor- tant to remember that smoking interferes with admini- stration of many treatment medications, increases risks of anesthesia and surgery, and impairs healing (42). That smokers are at very high risk for lung cancer, chronic obstructive lung disease, heart disease, ulcers, etc., needs to be considered in all medical evaluations (61). Finally, several childhood illnesses are associated with secondhand smoking (e.g., upper respiratory ill- nesses) (22, 23). Pointing out this relationship is often a motivator for patients to stop smoking. i. Ptrlmtutan• dlsc.t:c• Smokin, cessation impr<i\•es m,tn\- rr.pirator\ .\•ntp- toms tsometimes COu;h i: transiently worse rn the tira few weeksl ( I(+1 hut cau.e> no or little revc•r.al rn pul- mcman• function i 1 y-, 1481. In most ca.r., :r..anon does stop the accelerated decline in lung tunctumn with chronic obstructive pulmonary disease 1 I y-1. timokrr, who persist in smoking despite pulmonary disease ap- pear to he highly nictttinr dependent with a high inci- dence af alcohol problems (64. lyy): thus, treatment with nicotine replacement therapy and screening tor alcoholism are especially important in this group 11111. Also, smoking cessation increases theuphrllinr levels up to -30'•.. (42). Some have suggested pulmonars• function changes due to smoking can he used as moti- vattirs in such patients, hut this has not been well tested 150. 55). 4. C.trti er The risk for cancer declines with increasing duration (if abstinence from smoking ( I y-). In thcrse ss•hu alread\• have cancrr, cessation improves the quality of life (-3, 197). thus, cancer patients should still he advised to stop sm<rking 111. C:. DE\1OGR.aPHIC: A\1) 1'SYCH(KOC:IaI. VARIABLES 1. Eldcrhy The rates of smoking in those over 65 are lower than in younger persons (1 (200). Cessation in this age group is still beneficial both in terms of the length and quality of life (197, 200). There are programs tai- lored to the e)derh•, hut these have not been well tested to see if they are better than nontailored programs (200, 201). Behaviorally based programs appear to he effec- tive and are recommended with the qualification that cognitive deficits and depression are common in this group (111. The elderly do not appear to have greater side effects with nicotine replacement therapy (202), and this treatment should he ccrosidered.Il) I• 22 Ant f Psychiatry 1.53:10, October 1996 Supplement 51770 6913
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8 sponse to certain infections and diseases. What significance this may have for hu- mans is still being investigated. Cocaine In 1982, it was estimated that more than 20 million Americans had tried cocaine and more than four million were current users. Current users have increased to almost six mil- lion and the number continues to rise dramati- cally. Moreover, current and frequent users are more likely to report symptoms of depen- dency on the cocaine. What exactly is this seductive substance that has gained such popularity in recent years? Cocaine is a white powder produced from the leaves of the South American coca plant. It is known by a variety of names--coke, C, snow, blow, toot, nose candy and The Lady. Cocaine is a stimulant, a class of drugs that give a tem- porary illusion of limitless power and energy. Most cocaine users in this country snort the powdered drug through the nose, and some dissolve it and inject it into a muscle or vein, to experience the drug's fleeting "highs." Crack is a form of cocaine that is chemically altered so that it can be smoked. It belongs to a category of cocaine known as "freebase," be- cause the processing converts the drug into a chemical base as opposed to an acid or a salt. Smoking allows high doses of cocaine to reach the brain almost instantly. As a result, crack produces the most dramatic cocaine "high." This rapid "high" is followed, however, by a profound "low" that becomes a door to addic- tion. Cocaine is one of the most potent drugs of abuse. It causes chemical changes in the brain that lead to an intense craving for more of the drug. Anyone who tries cocaine or crack risks addiction. Dependency on these drugs is so powerful that they come to rule all aspects of the user's life. Addiction can erode physical and mental health, sap financial resources, ruin careers and drive off family and friends. Users fall into no particular stereotype. Many are well-educated, successful, upwardly mo- bile professionals in their 20s and 30s. But a cocaine user can be anyone-old or young, rich or poor, man or woman. Cocaine abuse and dependence follow one of two patterns of use: episodic and chronic daily, or almost daily, use. Episodic use may occur on weekends, for example, and once or twice during the week Among users who smoke cocaine or take it intravenously, "binges"-compressed time periods of con- tinuous high-dose use-are common. Binges terminate only when the user collapses from physical exhaustion or the supply of cocaine is depleted. An intense and unpleasant "crash" requiring at least two days of recuperation generally follows the binge. Chronic daily, or almost daily, use may be at high or low doses, and may occur throughout the day or be only during restricted hours. Although wide fluc- tuations in the amount of cocaine used from day to day are unlikely, doses generally in- crease over time. The effects of cocaine on the body are wide- ranging. Immediate effects include increases in blood pressure, heart rate, breathing rate and body temperature; dilated pupils; narrow- ing of blood vessels; loss of appetite and in- somnia. As use progresses, a loss of interest in physical appearance and frequent upper respi- ratory infections may become apparent. Those who snort cocaine may be bothered by a runny nose. As the effects wear off, the in- itial elevation of mood and sense of wellbeing fade into a depression characterized by disap- pointment, dullness and edginess.
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CHAPTER I INTRODUCTION, OVERVIEW, SUMMARY, AND CONCLUSIONS
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I ©Copyright 1988, 1989 American Psychiatric Association Produced by the APA Joint Commission on Public Affairs and the Division of Public Affairs. This pamphlet was developed for educational purposes and does not necessarily reflect opinion or policy of the American Psychiatric Association. Revised 1996 V1 1W 111 11 DEPRESSION ...N.~IW..~ The American Psychiatric Association is a cosponsor of the National Public Edu- cation Campaign on Clinical Depression in cooperation with the National Mental Health Association, Nation- al Alliance for the Mentally 111, National Depressive and Manic Depressive As- sociation and the DEPRESSION Awareness, Rec- ognition andTreatment (D/ART) Program, National Institute of Mental Health. The use of various substances to modify mood or behavior is generally regarded as normal and acceptable in our society, despite wide cultural differences. Many people drink cof- fee or tea for the stimulant effects of caffeine, or engage in the social drinking of alcohol. And certain drugs may be used medically to relieve tension or pain or to suppress appe- tite. When the symptoms and behavioral changes associated with regular use of these substances become maladaptive, however, substance use turns to substance abuse. Substance abuse-the misuse of alcohol, ciga- rettes and both illegal and legal drugs-is by far the predominant cause of premature and preventable illness, disability and death in our society. Alcohol and drug abuse afflict an esti- mated 25.5 million Americans. When the ef- fects on the families of abusers and people close to those injured or killed by intoxicated drivers are considered, such abuse affects un- told millions more. The annual cost of alcoholism is $89.5 billion for treatment and indirect losses such as re- duced worker productivity, early death and property damage resulting from alcohol-re- lated accidents and crime each year. Drug abuse accounts for another $46.9 billion a year in direct and indirect costs to business and the economy. This economic toll amounts to over four times that of cancer and nearly a third greater than that of cardiovascular dis- ease, according to a 1984 Research'IHangle Institute report. Among the disorders related to the misuse of Ln these substances, a distinction is made be- ~ tween substance abuse and substance depen- m dence. Substance abuse victims can't control ~ their use of alcohol or other drugs. They be- 'ro. come intoxicated on a regular basis-daily, m every weekend or in binges-and often need the drug for normal daily functioning. They re-
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13 Family members may choose to intervene to help get a cocaine user into treatment. Many professionals recommend a method called a family action plan or intervention. After sev- eral meetings with an experienced drug coun- selor, social worker, psychologist or other health professional, the family confronts the user and each member openly communicates how the user's behavior has affected him or her personally. Other participants in the inter- vention may include friends, employers or co- workers. During the actual confrontation, often led by a professional counselor, family and friends make it clear that the time has come to choose between them and the drug. The inter- vention is designed to catch the addict off guard and to overcome the likely denial. A crucial aspect of the process is presenting the user with treatment alternatives that can be started as soon as the intervention is com- pleted. Detoxification, ridding the body of the drug, is the starting point of any treatment pro- gram. This may be followed by medication, such as antidepressants, which help control the craving and relieve the severe depression that accompanies cocaine or crack withdrawal. Therapy programs also guide the recovering user toward other alternatives to curb craving for the drug. This help may be through a com- bination of individual, group and family coun- seling as well as other techniques aimed at changing behavior. The ultimate goal of recov- ery programs is to improve self-image and pro- mote healthful, drug-free living. Continued strength and support are also found by many recovering individuals by attending meetings of Cocaine Anonymous or Narcotics Anony- mous, self-help groups modeled after the Al- coholics Anonymous program. Professional support is also available to family members who need help for themselves as they strive to break out of the destructive environ- ment the user's addiction has created. One op- tion is a telephone call to an anonymous service like the nationwide hotline run by the National Institute on Drug Abuse (1-800-662- HELP). Family therapy is often helpful, as is individual support from a trusted friend, fam- ily doctor, clergy member or counselor. Among the support groups formed recently for the families of drug users are Nar-Anon for people whose lives have been affected by a drug abuser, Families Anonymous for families of drug abusers and COCANON groups for those whose lives have been affected by a friend or family member's cocaine habit. These groups have local chapters which are usually listed in the phone book. Opiates Opiates, also referred to as narcotics, are a class of drugs used medically as pain relievers, anesthetics or cough suppressants. Unfortu- nately, as a result of their powerful properties, they have a high potential for abuse. Some opiates come from resin taken from seed pods of the Asian poppy. This group of drugs includes opium, morphine, heroin and codeine. Other opiates such as meperidine (Demerol) are synthetics with morphine-like action. Opium is in the form of dark brown chunks or a powder and is usually smoked or eaten. Her- oin can be a white or brownish powder and is most often dissolved in water and then in- jected. Most street versions of heroin are di- luted, or "cut," with sugar, quinine or other substances to extend the supply and increase profits. Other types of opiates come in the form of tablets, capsules, solutions, syrups and suppositories
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14 An illegal drug also known as "junk" or "smack," heroin accounts for 90 percent of the opiate abuse in the United States, accord- ing to National Institute on Drug Abuse fig- ures. An estimated half a million Americans are addicted to heroin. Other opiates used for legal medicinal purposes may also be abused. These include morphine, meperidine, parego- ric (which contains opium) and cough syrups containing codeine. About half of those who abuse opiates de- velop a dependence or addiction. When some- one becomes dependent, obtaining and using the drug become the main focus in life to the exclusion of all else. As the drug is increased over time, greater amounts are needed to achieve the same effects. This tolerance can reach remarkably high levels. Opiates generally relax the user. When they are injected, the person experiences an imme- diate "rush." Other initial adverse effects in- clude nausea, vomiting and restlessness. The user may alternate between feeling alert and drowsy. In the case of extremely large doses, the user can't be awakened, pupils become smaller and the skin becomes cold, damp and bluish. Breathing slows down and death may occur. Opiate withdrawal symptoms usually begin within four to six hours of when a dependent user stops taking the drug. These symptoms include nausea, diarrhea, abdominal cramps, chills, sweating, uneasiness and runny nose and eyes. The intensity of the symptoms de- pends on the dose, how often the drug was taken and for how long. For most opiates, withdrawal symptoms are stronger about 24 to 72 hours after they start and subside within a week to 10 days. Symptoms like insomnia and craving for the drug can last for months. 15 I Most of the dangers of opiate abuse are asso- ciated with the use of unsterile needles, con- tamination of the drug itself, or mixing the drug with other substances. Eventually, opiate users may develop infections of the heart lin- ing and valves, congested lungs and skin ab- scesses. Infections from unsterile solutions, syringes and needles can lead to acquired im- munodeficiency syndrome (AIDS), liver dis- ease, tetanus and serum hepatitis. Scientists estimate that nearly half the women who -are dependent on opiates suffer heart dis- ease, anemia, diabetes, pneumonia or hepati- tis during pregnancy and childbirth. These women have more spontaneous abortions, premature births, stillbirths, breech deliveries and caesarean sections. And their babies often have withdrawal symptoms that may last several weeks or months. Many of these in- fants die. Reatment is available for opiate addiction. Most programs offer one of four basic ap- proaches:  Detoxification in a hospital or as an out- patient. This involves supervised with- drawal from drug dependence, either with or without medication.  Therapeutic communities where patients live in a highly structured, drug-free envi- ronment and are encouraged to help themselves. e~  Outpatient drug-free programs which em- phasize various forms of counseling as the main treatment.  Methadone maintenance, which uses methadone, a substitute for heroin, daily to help people lead productive lives while still in treatment. A synthetic drug, metha- done does not produce the same "high"
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ORDER FORM "Let's Talk Facts *About ..." pamphlets are available for sale in packets of 50 copies. 'Ib order, simply fill out the form on the next page and mail to the American Psychiatric Press, Inc.  Bulk discount: A bulk discount is avail- able on purchases of six or more packets of pamphlets. Any combination of titles qualifies for the discount, as long as each title is ordered in quantities of 50 pamphlets.  Free Sample Package: To receive a pre- view sample of all of the brochures, please send a check for $5.00 postage and handling to the American Psychiatric Press, Inc. at the ad- dress on the order form. Make check payable to the American Psychiatric Press, Inc. TzT.c~n 1're~r. L, 717tE 1400 K Street, N.W. Suite 1101 Washington, DC 20005 ORDER t N PACKETS ODpinp with HIV and AIDS MDXA2266 Nzheimer's Disease MDXA2264 Anxiety Disorder MDXA2250 Ch9dhood Disorders MDXA22S1 Choosing a Rychiatrfst MDXA2263 Depression MDXA?252 EaOnp Disorders MDXA?265 Manio-Dspnssiw Disorder MDXA22S3 Mental HeaRh of ehe Eldaly MDXA?254 Mental tNness (An Overview) MDxA?255 Obsessiw-Campubive Disorder MDXA225S Panic Disorder MDXA?2Q2 Phobias MDXA2257 Posttraumatic Stress Disorder MDXA22SS Psychiatric Med'ications MDXA?267 Sd+izophnnia MDxA?259 Subitanc*Abuse MDXA2260 Teen Suiade MDXA22S1 ToW padceb = x' S per pack = Subtohi cost _ + prepaid UPS ahqpirg • 55.00 Piimber d eampe pada x SS.00 = Total S - _  FREE SAMPLB A free sample of an individual pamphlet is availalbe from the American Psychiatric Association, Division of Public Affairs. Please specify by title the pamphlet you wish to receive and mail your request to: American Psychiatric Association Division of Public Affairs Department SQ 1400 K Stn3et, N.W. Washington, DC 20005 Your request must be accompanied by a stamped, self-addressed, business-sized envelope. I • 1-S pedcw • $19.50 pa padrst. 6 a more pednb • S1S.60 per psdw. SampU psckit • 1 psmpld.t of pcA bpio NAME _ ADDRESS CtN/STATE2IP (no P.O. Boxes please) Please drock mdhod of peyment (d orders must be prepaicl): O Check payable b Ameripn Paydiiahie Press, kro. Please charge my 0 Visa 0 Master Card 0 American Express Card Na Expiration Date Daytime Ptwne i s9^akire Dsle Ar orders sent by uPS. Pkase albw " weeks for deWery. Cal Glplomer aervioe Tol kee b ehvpe your order 1-000,3665m 9am-5pm EST. lubn&y-Frid.y 0+ to W 00
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2 peatedly try to stop using the drug but fail, even though they know its use interferes with their family life, social relationships and work performance, or that it causes or aggravates a psychological or physical problem. Substance dependence victims suffer all the symptoms of abuse plus a tolerance for the drug so that increased amounts of it are neces- sary for the desired effects. Opioids, alcohol and amphetamines also lead to physical de- pendence in which the person develops with- drawal symptoms when he stops using the drug. Alcohol Use For no other disease more than alcoholism has social stigma blocked the road to under- standing. Society has long viewed the afflic- tion as a psychological problem-the sign of a ravaged soul devoid of discipline or morality. Physicians are inclined to ignore its symptoms and victims deny its existence. Recent scientific breakthroughs, however, have begun to dramatically alter our views on alcoholism. The myth that alcoholism is al- ways psychologically based is yielding under the weight of evidence that the disease is largely biologically determined. This news holds significant hope for the estimated 18 million adult victims of alcohol (10.6 million alcoholics and another 7.3 million with seri- ous alcohol abuse problems), as well as the 56 million people directly affected by them. Such discoveries may eventually lead to prevention or detection of the disease before its damage becomes irreversible. The following characteristics of alcoholism leave little doubt as to the devastating impact of the disease:  Alcoholism is a progressive disease that - generally first appears between the ages of 20 and 40, although children can be- come alcoholics.  Drinking patterns vary by age and sex. At all ages, two to five times more males than females are heavy drinkers. For both males and females, drinking prevalence is highest and abstention lowest in the 21 to 34 age range. Among those 65 years and older, abstainers exceed drinkers in both sexes.  Alcohol dependence tends to cluster in families.  Alcohol dependence is often associated with depression, but the depression typi- cally appears to be a consequence of the drinking rather than a cause.  It takes five to 15 years for an adult to be- come an alcoholic; an adolescent can be- come an alcoholic, by contrast, in six to 18 months of heavy drinking.  Generally, abuse occurs in one of three patterns: regular, daily intoxication; drink- ing large amounts of alcohol at specific times, such as every weekend; and long periods of sobriety interspersed with binges of heavy daity drinking that last for weeks or months.  As drinking continues, dependence devel- ops and sobriety brings serious with- drawal symptoms such as delirium tremens (D'I§) that include physical trem- bling, delusions, hallucinations, sweating and high blood pressure.  Long-term, heavy drinking can cause de- mentia, in which the individual loses memory and the ability to think ab-
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B 62 million Americans had tried marijuana at least once in their lives at the time of a 1985 NIDA survey. Current use (past-month use) had decreased, however, by 1.8 million people. Marijuana is typically used in combination with other substances, particularly alcohol and cocaine. One out of every four young adults who have used marijuana say they usu- ally had an alcoholic drink at the same time. The combination of marijuana and alcohol ac- counted for more than half of the marijuana- related emergency-room cases in 1985. Cigarette smoking by very young children is another pattern strongly related to marijuana smoking. Young people age 15 to 17 who are current cigarette smokers are five times more likely to be current marijuana users. Boys and girls (age 12 to 17) are equally likely to try marijuana, but current users in the 18 to 25 age group are almost one and a half times as likely to be male. Many of the people who have tried marijuana use the drug extensively, and a substantial majority of heavy marijuana users will go on to try other illicit drugs. For example, 74 percent of those who have used marijuana 100 or more times have tried co- caine. The health consequences of marijuana de- pend on the frequency, duration and intensity of use, and the age at which use begins. Mari- juana has the following known and suspected health hazards that merit serious concern:  At commonly used doses, marijuana im- pairs short-term memory, concentration, judgment, information processing, percep- tion and fine motor skills. The risk of acci- dents while driving or operating complex machinery thus increases for those intoxi- cated with marijuana. Even when mari- juana use is discontinued, memory loss may continue for three to six months. . Marijuana impairs driving skills for at least four to six hours after smoking a sin- gle cigarette.  Smoking marijuana immediately acceler- ates the heartbeat and, in some individu- als, increases blood pressure, posing a threat to those with abnormal heart and circulatory conditions.  Specific psychiatric concerns include chronic anxiety, symptoms of depression and changes in lifestyle. There is particu- lar concern about long-term developmen- tal effects of marijuana use by children and adolescents. The term "amotivational syndrome" has evolved to describe the changes observed in some marijuana us- ers such as apathy, loss of ambition and effectiveness, diminished ability to carry out long-term plans, difficulty in concen- trating and a decline in school or work performance.  Although human lung cancer has not been linked solely to marijuana smoking, abnormalities suggestive of precancerous lesions have been reported. There are more known carcinogens in marijuana smoke than in cigarette smoke. However, since many marijuana users also smoke cigarettes, the combined carcinogenic ef- fect must be investigated. Marijuana sig- nificantly reduces the capacity of the lungs to exchange gas, even more so than does tobacco.  Marijuana may have serious effects on re- production. Some studies have shown that women who smoked marijuana dur- ing pregnancy gave birth to babies with defects.  In animals, marijuana has been shown to interfere with the body's immune re-
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0 CONTENTS Introduction ............................................................ 5 Development and Organization of this Report ......... 5 Overview ................................................................ 6 Major Conclusions .................................................... 9 Brief History Relevant to this Report .......................... 9 Chapter Conclusions ................................................13 Chapter II: Nicotine: Pharmacokinetics, Metabo- lism, and Pharmacodynamics ............13 Chapter III: Nicotine: Sites and Mechanisms of Actions .................... . .................... 14 Chapter IV: Tobacco Use as Drug Dependence ......14 Chapter V: Tobacco Use Compared to Other Drug Dependencies ..................................15 Chapter VI: Effects of Nicotine That May Promote Tobacco Use ................................... 15 Chapter VII: Treatment of Tobacco Dependence .....15 Appendix A: Trends in Tobacco Use in the United States ...........................................16 Appendix B: Toxicity of Nicotine ........................16 References .............................................................18 3
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26 American Medical Society on Alcoholism and Other Drug Dependencies 6525 West North Avenue, #204 Oak Park, Illinois 60302 (312) 848-6050 American Society of Addiction Medicine 5225 Wisconsin Avenue, N.W, Suite 409 Washington, D.C. 20015 (202)244-8948 Association for Medical Education and Research in Substance Abuse Brown University, Box G Providence, Rhode Island 02912 (401) 863-1109 Committee on Problems of Drug Dependence, Inc. 3420 N. Broad Street Philadelphia, Pennsylvania 19140 (215) 221-3298 Drug Abuse Information and Treatment Referral Line 1-800-662-HELP Spanish 1-800-66-AYUDA National Association of State Alcohol and Drug Abuse Directors 444 North Capitol Street, N.W, Suite 642 Washington, D.C. 20002 (202) 783-6868 National Clearinghouse for Alcohol and Drug Information PO Box 2345 Rockville, Maryland 20847-2345 (301) 468-2600 1-800-729-6686 National Council on Alcoholism and Drug Dependence 12 West 21st Street, 7th. Floor New York, NY 10010 (212) 206-6770 National Federation of Parents for Drug-Free Youth 8730 Georgia Avenue, Suite 200 Silver Spring, Maryland 20910 1-800-554-KIDS .27 National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-105 Rockville, Maryland 20857 (301) 443-3885 National Institute on Drug Abuse 5600 Fishers Lane, Room 10-05 Rockville, Maryland 20587 (301)443-6480 National Self-Help Clearinghouse 25 West 43rd. Street, Room 620 New York, NY 10036 (212) 354-8525 0>l1fiIlB Resources Visit the American Psychiatric Association's site on the World Wide Web. http://www.psych.org The text of this pamphlet is available in electronic format on the APAs Web site. http://www.psych.org/public info/ sub ab l.html
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The Health Consequences Of Smoking NICOTINE ADDICTION a report of the Surgeon General 1988 ~ ruumFF'S oEPOSmON at~~ U.8• DEPARTMENT OF HEALTH AND HUMAN SERVICES PubQo H.ddl aavle- GMKS for DN.u. CaNrol Con/or for HNpA Promollon and EOueaUon O/fic* on Smokinp.nd HoNM RoekvOb. Maeyl.nd 2O67 For alr by Ibe Sooerl.k.d..l of Dorn.nb, US. Cosr.mal rrlo8s Offlas VNuYMpo.. D.C. 30M2
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\h'07\t Dt.^FV"1F\.-; ability to self-titrate nicotine dose and to stop using it immediateh- before intermittent smoking e.g.. iduring passesi 1III1. In addition. many patients find that only a few pieces of gum per day are sufficient to prevent with- drawal symptoms (69. 190). The nicotine patch has the advantage of improved compliance and stable nicotine replacement. This ma% i+c r:rr:t.ili~ .i, ~,ir::.:_~,•~ . r differentiattnc nicotine withara%%ai rrvn; otnrr atric svmptoms iS:. One disaivanta,c rr ni;orim, ;. and patch is that patients may cnio-;c whiir u>in; t 11II1.Althou,h not desirable. rhi,saFnrarn it, i,e uniii,:: to produce signiiicant aivrrsr rftrct< V. CLINICAL FE.-kTURES INFLUENCING TREaTME\? A. PSYCHIATRIC DISORDERS 1. Alcohol/drug use/abuse Some 15°0-20°0 of heavy smokers have current al- cohol dependence or abuse (34). Smokers who have current alcohol/drug problems are unlikely to stop smoking permanently without overcoming the alco- hol/drug problems (34); thus, in most cases, alco- hol/drug abuse problems should be treated prior to or concurrent with the treatment of nicotine dependence [II]. About 80% of alcohol/drug abusers who are in treatment are smokers (1, 34). About half of such smokers are not presently interested in stopping smok- ing (34) and thus would benefit from treatments to in- crease motivation and readiness to change [II]. For the other half interested in stopping, whether it is best for them to stop smoking at the same time as they stop alcohol/drug use or to stop smoking immediately after or long after stopping alcohol/drug use is unclear (34). One rationale for stopping smoking at the same time as stopping alcohol/drug use is that use of each substance serves as a cue for use of the other substance; thus, by stopping both substances, such cues are eliminated. The major rationale for stopping smoking after stopping drinking/drug use is that often stopping drinking is a more urgent concern and that stopping two drug de- pendencies at the same time is just too difficult. Given the absence of empirical data, patient preferences for when to stop smoking in relation,to alcohol/drug abuse treatment should be respected [IIIj. A common concern is that smoking cessation will cause relapse to alcohol/drug use. Most of the available data do not support this (34). In two studies, 80%- 85% of recovering alcoholics reported no increased craving for alcohol nor did they relapse to alcohol use when they stopped smoking (2, 34). In fact, correla- tional studies_ suggest smoking cessation may decrease the probabiliry of relapse to alcohol (34). However, fre- quent monitoring during smoking abstinence is recom- mended in this group to help prevent the other 15%- 20% from relapsing to drinking during smoking cessation [III). Although not empirically tested, smok- ers who have a history of increased desire for alcohol during abstinence from smoking could either reenter or intensify ongoing therapy for alcoholism or could be prescribed a course of disulfiram [Illj. There are very little data on how to tailor a smoking cr:canon I+ro- gram to the specific needs of recuverin;, ;tlcohuii::: r._., whether such patients need a more intensive pno.,r.tni. would do better in a 12-step or behavior thrral+%pno- gram, or would need higher-than-normal dose ni:0tinr replacement because they are more nicotine dependent 134). However, recent studies suttcest treatment eit smoking may be effective either durine, or atter trrat- ment for alcoholism [111[ 1:4, 1941. 2. Depression Among patients seeking smoking cessation treat- ment, 25°0-40°o have a past history of major depres- sion and manv have minor dvsthvmic symptoms (2, 167). Since both have been shown to predict poor smoking cessation rates and since one studv reported that 33% of those with a history of bipolar disorder- and 18% of those with a history of unipolar depression relapsed to depression during smoking cessation (26), the psychiatrist should consider starting or restarting psychotherapy or pharmacotherapy for depression in patients who state that depression intensified with ces- sation or that cessation caused depression [III). This recommendation is based on the results of recent trials that found that cognitive behavioral therapy for depres- sion and antidepressants improved smoking cessation rates in those with a past history of depression or who had symptoms of depression (168, 180, 195). Finally, for a smoker with a past historv of depression currently taking antidepressant medication, it is important to note that some antidepressant levels will increase with smoking cessation [1I1 (8). 3. Schizophrenia Patients with schizophrenia who smoke are often not interested in stopping (33, 44, 196). Thus, strategies to motivate these patients to commit to quit are especially important [III]. When patients with schizophrenia do try to stop, many are unsuccessful (33); thus, intensive treatments are appropriate even with early attempts [IIIj. The high prevalence of alcohol and illicit drug abuse in patients with schizophrenia (33) can interfere with smoking cessation [I1]. The blood levels of some andpsychotics can increase dramatically with cessation and nicotine withdrawal can mimic the akathisia, de- Am J Psychiatry 153:10, October 1996 Supplement 51770 6 912 21
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18 as illegal drugs such as heroin, but does prevent withdrawal and the craving for other opiates. It can thus successfully break the cycle of dependence on illegal drugs. Hallucinogens Hallucinogens include such drugs as lysergic acid dyethylamine (LSD), mescaline and pe- yote. These substances are taken orally and can cause the abuser to experience hallucina- tions, perceptions of objects that have no ex- ternal cause. PhencycGdine (PCP) is sometimes referred to as an hallucinogen, al- though it rarely causes hallucinations in the true sense. These drugs came into popular use by young people in the mid-sixties. Since then, how- ever, there has been a steady decline in their use. In 1985, only 3.2 percent of American youths had ever tried hallucinogens compared to 5.2 percent in 1982. Recent users (past-year users) had also decreased from 3.6 percent to 2.6 percent for the same period. Most people are introduced to hallucinogens by experimenting with the drugs in social situ- ations. Some find the hallucinogenic experi- ence extremely vexing or gloomy and lose interest right away, while others enjoy it and continue using the substance. Use almost always occurs in intermittent epi- sodes, because the mind-altering effects of these substances impair cognitive and percep- tual functions to such an extent that the user generally has to set aside time from a daily routine to take the drug. Moreover, the fre- quent user may quickly develop a tolerance for the drug, which makes it virtually impossi- ble to take enough of it on a daily basis to ob- tain the desired effects. For these reasons, abuse is far more common than dependence. 17 Hallucinogens are often contaminated with other drugs such as PCP and amphetamines. In addition, users frequently smoke marijuana and abuse alcohol. The course of use is unpre- dictable, but most people resume their pre- vious lifestyle relatively quickly after a brief period of abuse or dependence. PhencycGdine can be taken orally or intrave- nously, or it can be smoked or inhaled. This substance is sold on the street under a variety of names, the most common of which are PCP, PeaCe Pill and angel dust. PCP is usually taken episodically in binges and "runs" that can last several days. However, some people chronically use the substance on a daily basis. Inhalants Inhalants are breathable chemicals that pro- duce mind-altering vapors. This group of sub- stances includes solvents, aerosols, some anesthetics and other chemicals. Inhalants are not usually thought of as drugs because that's not how most of them were intended to be used. Examples of inhalants are gasoline, glue, paint thinners, nail polish remover and lighter and cleaning fluids. Aerosols used as inha- lants include spray paints, hair sprays and cookware coating agents. Anesthetics include halothane and nitrous oxide, also known as laughing gas. Amyl nitrite and butyl nitrite are other com- monly abused inhalants. Amyl nitrite is a clear, yellowish liquid used for heart patients and for diagnostic purposes because it dilates the blood vessels and speeds up the heart rate. The substance is sold in a cloth-covered, sealed bulb that, when broken, makes a snap- ping sound. Thus the nickname "snappers" or "poppets." Butyl nitrate is packaged in small bottles and sold under such names as "locker
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22 The most common form of nicotine depen- dence is linked to the inhalation of cigarette smoke. The nicotine effects of cigarette smok- ing have a more rapid onset than with pipe and cigar smoking, tobacco chewing and the use of snuff. The habit pattern is more inten- sive and difficult to break due to frequent re- inforcement and greater physical dependence on the nicotine. The unpleasantness of withdrawal may add to the difficulty of giving up smoking. The nico- tine withdrawal syndrome includes craving for the drug, irritability, frustration or anger, anxi- ety, difficulty concentrating, weight gain or de- creased heart rate or appetite. Environmental cues such as the presence of other smokers and the widespread availability of cigarettes also surround the smoker with temptations. Evidence that nicotine is addictive has re- sulted from studies of the drug's effects on the brain and other parts of the body. Nicotine acts on specific receptors in the brain and other parts of the nervous system. It also re- laxes skeletal muscles and affects the heart, blood vessels and hormonal system. Smokers become addicted to the mood-alter- ing, stress-reducing properties of nicotine. Their performance has been shown to im- prove on some cognitive tests after smoking a cigarette, even on tests requiring sustained at- tention. And the drug also apparently helps to suppress appetite. Some smokers muster the determination and willpower to quit on their own. For others, the various stop-smoking programs offered by health care agencies, employers and various private groups around the country have been the answer. If we are to maintain momentum toward the goal of a smoker-free society, the Centers for 23 Disease Control recommends that govern- ment agencies, private organizations, health- care providers and others must work together to support programs and policies that encour- age non-smoking behavior. Possible steps to- ward the realization of this goal include the following:  Offer smoking prevention and cessation programs in schools, worksites, health- care facilities and other institutions.  Ban or restrict smoking in public places and worksites.ep  Restrict the sale of tobacco products to minors.  Ban all tobacco advertising. Provide reduced premiums for health and life insurance to nonsmokers.ep  Provide third-party reimbursement for smoking cessation programs.ep  Raise the cigarette excise tax. Bibliography General Information Bartimole, Carmella and John. TeenageAfcoholisrn and Substance Abuse. Hollywood, Florida: Compact Books,1986. Chatlos, Calvin. Crack New York: Putnam, 1987. Cigarette Smoking in the United States, 1986. U.S. Department of Health and Human Services, Centers for Disease Control, Morbidity and Mortality Weekly Report, Wl. 36, No. 35. Atlanta. Georgia: Centers for Disease Control, September 11,1987. Cocaine/Crack.• The Big Lie. U.S. Department of Health and Human Services, National Institute on
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20 (Nembutal). Diazepam (Valium), chlordiaze- poxide (Librium) and chlorazepate ('Il•anxene) are examples of benzodiazepines. Several sedative-hypnotics fall into a separate category. They include methaqualone (Quaa- lude, Sopor), ethchlorvynol (Placidyl), chloral hydrate (Noctec) and meprobamate (Mil- town). All of these drugs can be extremely dangerous when not taken according to a physician's in- structions. They can cause both physical and psychological dependence, and regular use over a long period of time may lead to toler- ance. Withdrawal symptoms are also likely to occur when regular users suddenly stop taking large doses of these drugs. These symptoms can range from restlessness, insomnia and anxiety to convulsions and death. Large doses of barbiturates can cause uncon- sciousness and death. With barbiturates, there is less difference than with other sedatives be- tween the amount that produces sleep and the amount that kills. Barbiturate overdose is a factor in close to one-third of all reported drug-related deaths, including suicides and ac- cidental drug poisonings. When barbiturates are abused, their effects are similar to the effects of alcohol. Small doses produce calmness and relax muscles. Slightly larger amounts can cause poor judg- ment, slurred speech, staggering gait and slow, uncertain reflexes. It is easy to see why driving a car or operating machinery become very dangerous if one abuses these drugs. Combining sedative-hypnotics with alcohol is especially dangerous. The use of these drugs with alcohol and other drugs that slow down body functions multiplies their effects and greatly increases the risk of death. Overdose deaths can result-whether deliberate or acci- 21 dental-when barbiturates and alcohol are combined. Women who abuse sedatives during preg- nancy may give birth to babies who are physi- cally dependent on the drugs and show withdrawal symptoms shortly after birth. Many sedatives pass easily through the pla- centa and are known to cause birth defects and behavior problems in the offspring of women who abuse these drugs while pregnant. Nicotine After years of controversy over the dangers of smoking, the latest report by the U.S. Surgeon General has confirmed that nicotine in to- bacco products is an addictive-drug compara- ble to heroin or morphine. The report showed a 37 percent decrease in smoking from 1975 to 1985. While this de- cline is certainly encouraging news, the fact re- mains that close to 50 million Americans still smoke cigarettes. And 320,000 deaths a year in this country are the result of tobacco prod- ucts. The prevalence of smoking among males con- tinues to be greater than that among females (29.5 percent for men; 23.8 percent for women), and figures remain higher for black smokers than for whites (28.4 percent for blacks; 26.4 percent for whites) Anyone who has smoked regularly can attest to the difficulty in giving up the habit. Most people try repeatedly to give up smoking with- out success. Studies suggest that the relapse rate is greater than 50 percent in the first six months, and at least 70 percent in the first year. After a year of abstinence, however, sub- sequent relapse is far less likely.
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Overview This Report of the Surgeon General on tobacco and health focuses on the pharmacologic basis of tobacco addiction. Previous Surgeon General's Reports have reviewed the medical and scientific evidence establishing that cigarette smoking and tobacco use in other forms are deleterious to health. Several reports emphasized particular diseases (e.g., 1982 Report on cancer (US DHHS 1982), 1983 Report on cardiovascular disease (US DHHS 1983a), 1984 Report on chronic obstructive lung disease (US DHHS 1984a)); some reports concentrat- ed on specific populations (e.g., 1980 Report on women (US DHHS 1980)); and some reports dealt with particular aspects of smoking (e.g., 1986 Report on involuntary smoking (US DHHS 1986a)). These reports have been important because so many individuals engage in a behavior that causes morbidity and premature mortality. The present Report addresses a central issue of the tobacco and health problem: Why do people smoke and in other ways consume tobacco products? Specifically, this Report reviews the pharmacolog- ic basis of the disease-producing and life-threatening behavior of tobacco use. Psychological and social factors. are also important influences on tobacco use, but a detailed review of these factors is beyond the scope of this Report. Reviews of this literature include previous reports of the Surgeon General (US DHEW 1979; US DHHS 1980, 1982, 1983a, 1984a), research monographs from the National Institute on Drug Abuse (NIDA) (Jarvik et a1.1977; Krasnegor 1978, , 1979a,b,c; Grabowski and Bell 1983), and articles by scientists who study tobacco use and nicotine (Russell 1971, 1976; Gritz 1980; Henningfield 1984). This Report reviews evidence that tobacco use is addicting and that nicotine is the active pharmacologic agent of tobacco that causes this addictive behavior. Previous Surgeon General's Reports have focused on evidence that cigarette smoking and tobacco use are health hazards. Now that those relationships are well-documented and well-known, this Report addresses addictive properties of cigarette smoking and tobacco use in order to help develop more effective prevention and cessation programs. This Report topic is particularly timely because of recent advances and extensive data gathered in the 1980s relevant to the issue of tobacco addiction. Since the early 1900s scientific literature and historical anecdotes have provided evidence that tobacco use is a form of drug addiction. In the 1970s, however, research efforts increased considerably on various aspects of tobacco addiction, including nicotine pharmacokinetics, pharmacodynamics, self-ad- ministration, withdrawal, dependence, and tolerance. In addition, advances in the neurosciences have begun to reveal effects of nicotine in the brain and body that may help to explain why tobacco use is reinforcing and difficult to give up. These issues are addressed 6
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B. S\fOF:ERS Vi'F-IO FLa\'E F.aILED I\ITi.aL TRE.-\T\lE\? 1. Dcliooutiun oj gruup This rroup is composed of smokers who have failed a trial of a known ettective formal therapy ie.,., heha% - ior therapy or nicotine replacement!. 2. .-1ssess ntcnt a. .Adc./u.tcY rij prior thcr.tfiy. As with treatment fail- ures with other psychiatric disorders. a first considera- tion is the adequacy of prior treatment 1111J."Hclw many sessions of behavior therapy were atrended ' What was the quality of the behavior treatment in the last quit attempt% What were the doses of gum or patch used? What was the duration of therapy- What was the level of compliance with the psychosocial or somatic ther- apy% How long did the patient remain ahstinent't 6. Cause oj relapse. Another important consideration is to determine the perceived cause of the relapse 11111. Was the relapse due to uncontrolled withdrawal symp- toms, environmental stressors. alcohol use, negative or positive mood, or being around other smokers'c \Vere there factors (e.g., fatigue. life disappointments, tam- ilv/social stressors) that undermined cessation% c. Motivation to stop. The clinician should encourage the patient to try to quit acain, and if the patient agrees, a new quit date should be set 1111. What was the pa- tient's satisfaction with prior treatments: Vi'hat did he or she learn from prior failures'r If the patient is not ready to try again, what are his or her fears and what are the barriers to attempting nain: What changes does the patient think need to he made before another attempt is made'r d. Search jcrr cnmorhiditr. Most smokers have not been assessed for psychiatric or aicohol/drus; abuse problems initially and such problems interfere with ces- sation (2, 167); thus, screening for such disorders is in- dicated JIIl. In prior studies, 1 S';,.-?0",, of heavy smok- ers have current and up to 351.. have past alcohol problems (186) Similarh•, 40"1. of smokers seeking treatment have a past history ot:depressiun l'_, 167). .3. Psvcbiatric maaagement/use of psycbosocial and pharntacological treatntertts a. Prior treatme,tt inadequate. If the prior treatment appeared appropriate hut was inadequately imple- mented, the therapy may he repeated with chanl;es to insure the fidelity of therapy, compliance, adequate dose and duration, etc. I 1111. b. Prior treatment adequate. If the prior treatment was appropriate and adequate, the psychiatrist should attempt to determine whether the relapse was due to withdrawal symptoms versus nonwithdrawal causes. 1) Relapse due to withdrawal. If the prior relapse appeared to he caused hy withdrawal symptomatolog.• and the patient has not previously been treated with nicotine replacement, nicotine patch therapy is appro- l+riatr 111. Ir the patient h.l• rc•rn .t,i1.lu.t;r:~ ;:.1;~.: nicotine pat;il tncrap%. tnrn ;wni,i:nc ll patch piu. nl:ormc• _unl I ll .. Ili:ot111C• na%.l, %;`7.1C : 11 o' ht;,her-doae nicotine patch I Ill i mac pIy rc•-treanng, with nt:otlnr t+at;h thrrapc 1, mot effectt~c• :I ~~. 1-1N. IS-. I~S . U.r ot nl:onnr n.l..l. spray is re:ommenJr.1 hc•:au.c• thl, .1rlt%erL mo.ir pn-- duce: a more holu.-likr ciirct that might better rC•iic•%: withdrawal and cravln_ 1I111 ' 1 :r, . Use ut ntaotlnc tt.t:.tl :rr.ls inittalk .1n.1 titc•r s\\'itchin,.1 to ni:tltillt• rar:h or tn'.' ~i~n:nI111Lltlt ll~t' 01 nicotine nasal .pra% and nlaorlnr pat:il h.lsc al.o proposed i 1141 hut ha% c• rnot been tr.tru. The ranonai; for the use (if clonidlne• 1. .Iml•ic tt, trc .1 mr,il;attul: from a different cla... A tlnal po<.ihilm I..vmpnnnan; treatment based on the type fit wIthdrawal ynlrtom• ie.g., antidepressant, hor withclrawal-Indu:rd c1r),re•• sion). Although lu,alcal, this srrano,c has mit hc•rn a.ir- quatel.• tested. 31 Relapse ~Inc• to , An illtf•rth,lr.ttr•.tl.:tri,•;:, ir. If tiu smoker has relapsed due to a.trr>:fttl lite c•% rnt and ha, not pres•iousl.• been treated with hrhaviur thrr,tpy. it should he considered. It the patient has alread% had hc- havitlr therapy, two choicc•s are availahlr: I I more in- tensis•e behavior therapy 11111 or ?t IKhavit+r thrrap% with a different content or format- i.e., group thrral+y, individual thrral+y, combined individual and group therapy, or involvement of tamily members 11111. Whether these treatments Wuul.l he effective for those who have failed prior behavior therapy has not been tested. Switching to nomhrhavioral psychosocial treat- ments (e.,a., hypnosis or I?-strp therapy) is not rr«t'm- mended because there is no empirical support for their efficacv. .iI G,ntlunc•d th.rntpr. ti,~mrtitncs it i% difficult to distinguish withdrawal vrr,us nonwithJraw;tl cattsc•s of relapse. In this casr, the patient may hr a candidate fur cnmhinrd pharmacological and hrhavii.ir therapy (1?ti, 129)1111. 4) i:c'li•rr,tl. \1'hc•n thr trcatim" psychiatrist durs not have the knowledge nccrs.ary to implement the treatmrnt. ciutlinrd here or if thr.tratcl;ics arc admin- istcrcd and the snutkcr is not ahlc• to quit, referral to someone who sl+ecialir.r% in treating nicotine depend- ence should he considered (III1. •i/ Inpatient prugrams. An inpatient model for smoking cessatir.,n has been described (189) and appears to produce high quit r:urs, especially given the hil;hly nicotine-dependent smokers enrolled. There are no con- trolled trials that substantiate this at the current time. C. TRF11TAlE:\T OF SMOKERS ON SMOKE-FREE WARDS 1. I ntrudttctiout This section focuses on psychiatric patients an smoke-free wards, hut the same principles apply to smokers on general medical wards seen in consultation and to smokers in smoke-free nonmedical settings; e.l;., Am J Psychiatry 153:10, October 1996 Supplement 51770 6910 19
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v strong, often irresisti- quit or even repeated erred to as "habitual" om habitual behaviors aed that a drug with )rain enters the blood ined by the occurrence psychoactive chemical rcer that can directly ; ingestion. alp characterize drug . drug-taking behavior regular temporal and ypic); (2) drug use may ical, or social conse- wed by resumption of ise the drug may be ig abstinence. Similar- producing drugs can rease the likelihood of overall level of drug :ce) to the effects of a ased intake over time; )ns (due to physical e; (3) effects that are ier can be provided by :n also produce effects iany addicting drugs of various disorders. jicting, however, are s of a drug considered -iitiation of drug use, lapse following cessa- Report in light of the • Report is as follows: )mpanied by orderly -)rain resulting in the w of how effects of :)ody are chemically nce that tobacco is drug (Chapter IV); and of nicotine with f possible effects of and present impedi- ew of strategies for helping people to achieve and maintain tobacco abstinence (Chapter VII). In addition, appendices are included that summarize informa- tion regarding trends in tobacco use (Appendix A) and information regarding the toxicity of nicotine itself (Appendix B). A summary of the main findings of the Report follows. Major Conclusions 1. Cigarettes and other forms of tobacco are addicting. 2. Nicotine is the drug in tobacco that causes addiction. 3. The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. Brief History Relevant to this Report Tobacco products have been used for centuries. The tobacco plant was native to the New World. The oldest cited evidence of tobacco use appears on a Mayan stone carving dated from 600 to 900 A.D. There are reports of tobacco smoking in Christopher Columbus' diary in 1492; reports of tobacco smoking appear in the logs of other European explorers of the New World in the 16th century. Since the colonial period, tobacco has been an integral part of the American economy (Robert 1949). Tobacco use permeated the New World and quickly spread throughout the rest of the world during the 16th and 17th centuries. As use of tobacco products spread, so did controversy over the effects of these products. Throughout history, while some persons extolled the virtues of tobacco (including numerous alleged medicinal uses), others condemned its use. George Washington is attributed with exhorting the home front during the Revolutionary War, "If you can't send money, send tobacco." In contrast, Dr. Benjamin Rush condemned tobacco use in his 1798 book Essays. The controversy continued into the 19th century with no convincing scientific or medical evidence to support either position (Robert 1949). In 1856-57 the British medical journal Lancet published opinions of 50 physicians on tobacco use. Many opponents attributed in- creased crime, nervous paralysis, loss of intellectual abilities, and visual impairment to tobacco use-all of these claims lacked convincing evidence. In restating the main arguments of the tobacco proponents, the Lancet editors wrote that tobacco use "...must have some good or at least pleasurable effects; that, if its evil effects were 9 r
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)n tobacco and health focuses addiction. Previous Surgeon edical and scientific evidence 3 tobacco use in other forms )orts emphasized particular 'S DHHS 1982), 1983 Report 83a), 1984 Report on chronic a)); some reports concentrat- ~port on women (US DHHS rticular aspects of smoking :g (US DHHS 1986a)). These many individuals engage in oremature mortality. al issue of the tobacco and .nd in other ways consume t reviews the pharmacolog- fe-threatening behavior of -actors are also important review of these factors is of this literature include JS DHEW 1979; US DHHS graphs from the National al. 1977; Krasnegor 1978, articles by scientists who 1971, 1976; Gritz 1980; :cco use is addicting and ent of tobacco that causes General's Reports have ng and tobacco use are ips are well-documented addictive properties of ~r to help develop more as. cause of recent advances relevant to the issue of :cientific literature and e that tobacco use is a wever, research efforts of tobacco addiction, macodynamics, self-ad- tolerance. In addition, z to reveal effects of to explain why tobacco -se issues are addressed in this Report. Finally, recent developments in the use of nicotine replacement in smoking cessation emphasize the importance of pharmaco,logic aspects of cigarette smoking. Concepts of drug addiction or drug dependence are discussed in detail in Chapters IV and V. It is useful to begin this Report with a brief summary of main points about drug dependence that provide the foundation for the findings of the Report. The terms "drug addiction" and "drug dependence" are scientiCi- cally equivalent: both terms refer to the behavior of repetitively ingesting mood-altering substances by individuals. The term "drug dependence" has been increasingly adopted in the scientific and medical literature as a more technical term, whereas the term "drug addiction" continues to be used by NIDA and other organizations when it is important to provide information at a more general level. Throughout this Report, both terms are used and they are used synonymously. The main conclusions of the Report are based upon concepts of drug dependence that have been developed by expert committees of the World Health Organization, as well as in publications of NIDA and the American Psychiatric Association. These concepts were used to develop a set of criteria to determine whether tobacco-delivered nicotine is addicting. The criteria for drug dependence include primary and additional indices and are summarized below. CRITERIA FOR DRUG DEPENDENCE Primary Criteria . Highly controlled or compulsive use . Psychoactive effects . Drug-reinforced behavior Additional Criteria . Addictive behavior often involves: -stereotypic patterns of use -use despite harmful effects -relapse following abstinence -recurrent drug cravings . Dependence-producing drugs often produce: -tolerance -physical dependence -pleasant (euphoriant) effects The primary criteria listed above are sufficient to define drug dependence. Highly controlled or compulsive use indicates that drug- 7
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\I:k"Tl\F (~~(`t\hE\~'; :mle, and \lanacemen:. Edtted i,,- Oriean: CT. Slide JD. \e.. Yori:. Uxtord L ntcertn Pres,• l -a_, p,t• _a 5-_t, 1 IF; 11:. Siiac> C. Manc D. Fo%%-ie: G. Lodec \1: \Ieta-anah•st, on eii:- :ac: oi nicotine repiacemenr tnrrapus in smoking :eisanor.. Lancet 19aa: :.13:13t+-14= IEj I I e. Lee EW. D:alonzn GE: CGc.trear smoktn_. nicotine ad.ir.no: and its pharma:oioct: treatment. arcn Intern \led 1`1'33: 1 3;--tS IFJ 11-. Xunn-Thompson CL. Simon PA: Pharmacotherap}• for smok- :ng.essation. Clin Pharm 1959: S:-1(L-?01FI 118. Pomerieau Q. Pomerigau C• Facerstrom K. Hennatgneld JE. Hus;nes IR: \icotine Replacement: A Cntt:al Eraluanon. New York. Ha%.•orth Press. 19SS IFJ 119. Fagersrrom K: Combined use or nicotine replacement products. Health \'a(ues 1994. 1S:15-201FJ 120. Rose JE: Transdermal nicotine and nasal nicotine administra- non as smoking cessation treatments. in The Clinical Manage- ment of Nicotine Dependence. Edited by Cocores JA. New York. Spnnger-Verlag. 1991. pp 196-20- IF) 121. Prignot J: Pharmacolo¢ical approach to smoking cessation. Eur Respir J 1989: 2:550-560 IF) 122. Jackson PH. Stapleton JA. Russell \1AH. \lerriman R,I: Predic- tors of outcome in a general practitioner inten•ennon aCainst smokinc. PrevMed 1956; 15:2•ia--353 laI 123. Huches JR: Non-nicotine pharmacotheraptes for smoking ces- sarton. J Drug Dev 1994; 6:19--203 IF) 124. Cepeda-Benito a: Jleta-analytical review of the effiean• of ni:o- ttne chewing gum in smoking treatment programs. ) Consult Clin Psvchol 1993: 61:822-830 (E1 125. Covey LS. Glassman AH: A mcta-anal>•sis of double-blind pla- cebo-controlled trials of clonidine for smoking cessation. Br J Addict 1991: 86:991-998 IEJ 126. Gourlav SG. McNeil JJ: Antismoking products. Med J Aust 1990: 153:699-70- ICJ 12-. Tang JL. La.e \l. Wald N: How eftective is nicotine replacement therapy in helping people to stop smoking'r Br Med J 1994; 3308:21-25 IEJ 128. Hughes JR: Combining behavioral therapy and pharma- cotherap}• for smoking cessation: an update, in Integrating Be- hacior Therapies With \ledicanon in the Treatment of Drug Dependence: NIDA Research Monograph 150.Edited by Onken LS• Blatnr JD. Boren JJ. Rockvillc. Md. National Insti- tute on Drug.•lbuse. 1995, pp 92-lOQ (EI 129. Hughes JR: Combined psychological and nicotine gum treat- ment for smoking: a critical review. J Subst Abuse 199 1:3:33'- 350 IEJ 130. Henninghrld JE. Stapleton JIM. benowitz NL. Gra\..on RI-. London ED: Higher levels of nicotine in arterial than in venous blood after cigarene smoking. Drug Alcohol Depend 1993; 313: '-3-29IGJ 131. Palmer KJ. Faulds D: Transdermal nicotine: a review of its phar- macodynamic and pharmacokinetic properties. and therapeutic use as an aid to smoking cessation, Drugs 1992; 44:49h-529 IFI 132. Hughes JR. Glaser M: Transdermal nicotine for smoking cessa- tion. Health Values 1993; 17:24-31 FFI 133. Fiore AMC, Smith SS, Jorenbv DE. 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Behm FM: Rcnne.: ;~zarc... ...•...; .t. .. w .... ,-,. .. re.iuanc nicotine m:ai.a. Pnarau:.~: h:,~;nrr.: fwr:: '~~ - .;U3-3 10I,A; 140. RusseC \1AH. larn t: \1l. surncrian.i (.. F;.rra ti•s_; repla:emenr in smoking te>sanur...I.\M.a fG' 141. butneriand G. Rus:ell \t aH. xarictan IA. Fcvc:a~-n.i ero( narn.le acarertes: a le>. harm:u; ortum tar rar,m:, .:;n... ers. Tnorax 1 Qa?: iS:.S.;-?S- ! a 14_. Oas•tson GC. Rosen Rt.:: Lurci:nc an-; reau:no:: a: ;:L:•uer: smoking. Ps.•thol Rcp ;.\; 143. Sachs DPL: Ette.Zt.•enc» ot + mc r••:.rnn; p,.ia:rnrx t.,r rn; initial treatment ot htcn-dcpCnderr. .m..r.cr.. .\r:n Intcrr. \lc.: 194.5. I:5:19-:-1 yt:0 IAI 144. Rose JE. Behm FM: Lobcitne aeru.ai rr.iu:r. :ra% mt tur ;tca- renes. in Proceedings ot the Ist \tectm}; ot thr k+:ict% tor Kc search on Nicotine and Tobacco. Rcthe.da. \Li. aocrct% tor Rc- seatch on Nicotine and Tobacco. luu* 5, r t.5 JA1 14 5. Lam VC•L, Sze PC. backs HS. Cha(mer T(:: \leta•anah a..it ran• domized controlled trials ot nuunna• cnc..•mr cun:. l an:et 19S'•2•2--29 IE1 1ie. Po AL\C': Transdermal nt:onnc in smuktn};:easanan. k.ur I t lu: Pharmarol 1993. a5: 5 1 y-5-'8 I F. I 13-. Sutherland G. Stapleton IA. Russell \lAH. Jars•ta \I I. Hatck 1'. Bel:her.M. Fe.•erabenJ C: Ran.ktmueJ :untrolleJ trial s:t na.al nicotine spray in smoktnc:essanon. Lancet 1 yy_: 3at1:.:_4-.+?~ Ial IiS. Hialmarson A. Franzun M. Westin A. \\'ikiunJ 0: Eftect at nicotine nasal spray on smoking .ess,mtsn. Arch Intern Sl:cd 1994: 1=4:_56 -__ : J:11 149. US Department of Health and Human 1rn•icrs: Smoktnc dcter- tent drug products for oeer-thr-.uunter human use: estah- lishment of a monograph. Federal Register 1982. 4':491>_StNI IGI 150. Hurt RD. OfforJ KP. LauFcr GG. Marusic Z. Fagctstn.m K. Enright PL Scanlon PD: Ccssation of long-term nicotine gum u>r: a prospeais•r. randomized tnal.-AdJi.-non 1993. 90:411'- 41.;IjI 1:1. Ftore \1C. Jorenhy I)E. Bakcr TB. F:rnford SI : Tuhac.•n Jr- t•enden.c and the nicotine pat:h::lmt.al guidelines for rttr:tnr usc. JA\IA 1992: 263:2hl:--2hy4 IFI IS_. \\'etter DVf', Fiore MC. Baker TB. Young TB: Tobacco atth- drawal and nicotine replacement influence ohiectivr measures of sleep. J Consult Clin Pxv:hul 1`+y5; 63:651t-66- IA) 1.; 3. Cox JL: Algorithms for nicotine withdrawal therapy. Health Values 1993; 1-:;1-itl I(il 134. HuFhes JR: An algorithm for smokinysccssatwn. Arch Fam \ird 19114: 3:2311-285 IGI 155. FaFerurom KO. \felin B: Nicotine chewing gum in smoking cessation: efficacc, nicotine dependetxc, therapy dutation, and clinical recommendatians, NIDA Res \lonogr 1983. 53:102- 109 (FI 156. Hatsukami DK. Huhcr AI, Callics A. Skoug K: Physical depend- ence on nicotine gum: effect of duration of use. Psvchopharttw- coloFy tBetll 1993. 111:;4yr1$6 IAJ 15'. Clarke PBS: Nicotinic receptor blockade therapy and smoking cessation. Br )Addia 1991; 86:501-505 IF1 158. Stolerman IP. Goldfarh T. Fink R, Jarvik ME: Influencing ciga- rette smoking with nicotine antagonists. Ps,vchopharmacologia 1973: 28:24'-259 IFJ 159. Rose (E. Levin ED: Concurrent agonist-antagonist administra- tion for the anah-sis and treatment of drug dependence. Phar- macol Biochem Behav 1991; 41:219-226 JA) 160. Rose JE. Behm FM. Westman EC, Levin ED, Stein RM. Ripka GV: Mecamvlamine combined with nicotine skin patch facili- tates smoking cessation beyond nicotine patch treatment alone. Clin Pharmacol Ther 1994; 56:8G-99 (Gj 161. Rounsaville Bj: Can psychotherapy rescue nahrexone treatment of opioid addiction?, in Integrating Behavior Thenpies With Medication in the Treatment of Drug Dependence: NIDA Re- search Monograph 150. Edited by Onken LS, Blaitte JD, Boren Am J Psychiatry 153:10, October 1996 Supplement 51 770 6920 29
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use of tobacco products, such as in adolescents first beginning to smoke, is usually accompanied by a number of unpleasant symptoms which disappear following chronic tobacco use. Chapter III: Nicotine: Sites and Mechanisms of Actions 1. Nicotine is a powerful pharmacologic agent that acts in the brain and throughout the body. Actions include electrocortical activation, skeletal muscle relaxation, and cardiovascular and endocrine effects. The many biochemical and electrocortical effects of nicotine may act in concert to reinforce tobacco use. 2. Nicotine acts on specific binding sites or receptors throughout the nervous system. Nicotine readily crosses the blood-brain barrier and accumulates in the brain shortly after it enters the body. Once in the brain, it interacts with specific receptors and alters brain energy metabolism in a pattern consistent with the distribution of specific binding sites for the drug. 3. Nicotine and smoking exert effects on nearly all components of the endocrine and neuroendocrine systems (including catechol- amines, serotonin, corticosteroids, pituitary hormones). Some of these endocrine effects are mediated by actions of nicotine on brain neurotransmitter systems (e.g., hypothalam- ic-pituitary axis). In addition, nicotine has direct peripherally mediated effects (e.g., on the adrenal medulla and the adrenal cortex). Chapter IV: Tobacco Use as Drug Dependence 1. Cigarettes and other forms of tobacco are addicting. Patterns of tobacco use are regular and compulsive, and a withdrawal syndrome usually accompanies tobacco "abstinence. 2. Nicotine is the drug in tobacco that causes addiction. Specifi- cally, nicotine is psychoactive ("mood altering") and can provide pleasurable effects. Nicotine can serve as a reinforcer to motivate tobacco-seeking and tobacco-using behavior. Toler- ance develops to actions of nicotine such that repeated use results in diminished effects and can be accompanied by increased intake. Nicotine also causes physical dependence characterized by a withdrawal syndrome that usually accompa- nies nicotine abstinence. 3. The physical characteristics of nicotine delivery systems can affect their toxicity and addictiveness. Therefore, new nicotine delivery systems should be evaluated for their- toxic and addictive effects. Chapt, cies 1.1 t t 2.1 c ~ 3. : c c Chapt~ Depen Chapt
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"Psychological Issues in Informed Consent" by William C. Thompson pected,' or that a certain procedure poses a 'moderate risk,' can the patient extract from those terms an accurate impression of the probabilities the doctor has in mind?" "A recent study indicated the problems of communicating likelihoods in linguistic terms by showing that doctors themselves ascribe widely different meanings to words typically used to define probability. Sixteen doctors were asked to indicate the numerical probability they associate with 30 common words or expressions of probability. The doctors who conducted the study conclude that 'The wide variation observed in the subjective probabilities is apparently due to consistently different interpretations of expression by individual physicians.' They argue that doctors should use numerical probabilities in communicating with each other." "If doctors cannot understand each other when they use non-numerical terms of likelihood, we can hardly expect their patients to understand them." The author draws a number of conclusions from his review: "...as the research reviewed above indicates, simplicity in disclosures does not insure accuracy of comprehension. People are quite likely to form inaccurate assessments of risk on the basis of simple easy to understand disclosures. So it is not enough that patients understand what the doctor is telling them they must also be able to draw appropriate inferences from it. It is quite possible for patients•to 'understand' a disclosure but misconstrue its import." "As the studies reviewed earlier indicate, people often draw strikingly inaccurate conclusions about the risks they face on the basis of relatively simple information that is much like the information patients must evaluate in making important medical decisions. These studies suggest that subtle biases in the way people process and use information must be taken into account by those who seek to 'inform' patients of risks."
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ORDER FORM "Let's ThIk Facts About ..." pamphlets are available for sale in packets of 50 copies. Tb order, simply fill out the form on the next page and mail to the American Psychiatric Press, Inc.  Bulk discount: A bulk discount is avail- able on purchases of six or more packets of pamphlets. Any combination of titles qualifies for the discount, as long as each title is ordered in quantities of 50 pamphlets.  Free Sample Package: To receive a pre- view sample of all of the brochures, please send a check for $5.00 postage and handling to the American Psychiatric Press, Inc. at the ad- . dress on the order form. Make check payable to the American Psychiatric Press, Inc.  FREE SAMPLE A free sample of an individual pamphlet is availalbe from the American Psychiatric Association, Division of Public Affairs. Please specify by title the pamphlet you wish to receive and mail your request to: American Psychiatric Association Division of Public Affairs Department SG 1400 K Street, N.W. Washington, DC 20005 Your request must be accompanied by a stamped, self-addressed, business-sized envelope. 1400 K Street, N.W. Suite 1101 Washington, DC 20005 T)TLE CRDER // N PACKETS Coping with HIV and AIDS MDXA2266 Alzheimer's Disease MDXA2264 Anxiety Disorder MDXA2250 Childhood Disorders MDl(A2251 Choosing a Psychiatrist MDXA2263 Depression MDXA2252 EaEng Disorders MDXA22E5 Manic-Depressive Disorder MDXA2253 Mental Heakh of the Elderly MDXA2254 Mental Illness (An Overview) MDXA2255 Obsesaiw-CanpulsiYe Disorder MDXA2256 Panic Disorder MDXA?282 Phobias MDXA2257 Posttraumatie Stress Disorder M DXA?258 Psychiatric Medications MDXA2287 Schizophrenia MDXA2259 Substance Abuse MDXA2280 Teen Suicide MDXA2261 Total packets : x• S per pack . Subtotal coel _ + prepaid UPS shipping ~ $5.00 Number of aampb pado x $5.00 =- Tota) 3 - _ • 1-6 pedcsts - $19.50 per padkst. 6«more psdceb. s15.tj0 pr pedcet. Sartple psdast .1 psmpWst of ssoh lopia NAME ADDRESS (no P.O. Boxes please) CITY/STATE/ZIP Please check method of payment (a orders must be prepaid): 0 Chedc payable to American Paychiatric Prese, kx:. Please charge my 0 Visa O Master Card 0 American Express Card ra. Expiration Date Daytime Phone ~ sold" Date Ap orders sent by UPS. Please allow 48 weeks for delivery. CaA Cwtomer eervioe Toll Free to charge your ader:1 40t),968-5m 9am-5pm EST, MbrwiapFriday
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\ICOTI\E DEPE\DE\C:E .acencv ror Health Care Plll:a Re.car:h American A,aJrmv clt Ci:nl:al P.c;hlarn.t• Amrn:an .\,aJrmt or 1'r.i:arn:. American A,.Il,iaritm of lui,~t.lnlt,_t American College ot C.ard:elh~,t American College ot Prrtenntr \IrJtcrnc• American Medical .asetctarion American Psvchoanal.•ti. .as,t>;iancm American Scnten of AJdi.non Medicine Association tor Advancement of Behavior Therdpy - Center tttr Substance Abuse Prevennon Center rllr Tl,ra;;ll I:r•rar;n ac,: l:.•, .., Thr C-t>;hranc• l.uliahoratlot: The \Iemmnec•r I•tlun.:arnl:• N.ttllln•1i A%!-Uaatlltll tl! \A l nlCr• o' V•~: Cl:.:•-' National Lan;rr In.ntutc• \anuna! Inctntutc• tin 1)ru_ Ahu• National Instttutc• tu Health National In:tttute of \Irntal Health Pakistan Psc:htarn: St,:irtn t,r \tlrth amrn;: Rclt'aI C.olleer of I'•t:htatn<t. Srtaett' for AJolr.;rnt \lr.it:tnc \1'estern I':v:htatn; In.ntutr an,i k Inu, \'III. REFERENCES The following coding system is used to indicate the nature of rhe supporting evidence in the summary recommendations and references: JAI Randomized clinical trial. A study of an inter- vention in which suhlects are prospecttveh ' followed over time:'suhjecrs are randomlv ac- signed to treatment and control groups; hoth the subjects and the investi;,ators are blind to the assignments• except psychoawial treat- ments may nur be double-blind. JBI Clinical trial. A prospective study in which an intervention is made and the re.ult> of that in- trrvention are tracked IongituJinally; study does not meet standards for a randomized clinical trial. ICI Cohort or longitudinal study. A study in which subjects are prospectively followed over timr without any specific interventiun. IDI Case-control study. A study in which a_rtlup of parients is identified in the present and tn- tormarion about them is pursued retrospec- tivelv or backward in time and compared to matched control suhjects. JEJ Review with secondarv data analysis. A struc- tured analvric review of exisnn-, data: e.~,.. a meta-analvsis or a decision anaf.•sis. JF1 Review. A qualitative review anJ discussion of previouslv published literature without a quantitative synthesis of ihe data. IG) Other. Textbooks, expert opinion, case re- ports, and other reports nor included above. I. American Psechiatri. •asawiation: IhaLnl/.n: and 1tan.nc:il Manual of Mental Disorders. 4rh eJ. \1 a.hmgtun, I)C, :\I'.a Iy94IGI 2. Glassman AH: Cigarette cmrtkrn);: tmplicannnm f//r p.cchlatn: Iness. Am I Ps~•chiatn' 1993; I.it1::4(.-:5.i IFI 1 3. US epartment of Health and Human Sen•icec: Clinical Practice Guideline 111111 Smoking Cessation. Washinl¢ton, DC., US Gm- ernment Printing Office, IF.(_ _ ._ - mencan syc ratrtc Association Council on Research: Prtsi- tion statement on nicotine dependence. Am J Psvchiatn• 1995. 152:481-482 IGI 5. LJS-Departrexni of~iealth and Human Sen ices: Preventing To- bacco Use Among Young Penple: A Report of the Surgeon Gen- eral. Washington. DC, US Grwcrnment Printing Office. 1994 IFI 6. US Department of Health and Human Servtces: Bibliography an Smoking anJ Health: >rirar,i .innllcafum.. 1)C. l•S (,Itccrnmrnt Pnnnn_ ltal,c. I"`+a il. -. Silaa'C:.(~rat ti.FI,.tlrr(/.Ian;aarrT:Ititrint•mrn:w.1 srt:mr rt•etctcr Ilr .Inllklt>_.c..awln tna .. l Ilntn.: t iu: l:I.It, nn prc..! lEl S. Hughr, IR: PIt~Nhlt•Cfft'~r~l~f N11UAt'•rry'1' Itll`.lllt'nt lllllt•o:l I,„ :htatn: Jla_nn.n anJ trraemrnt. I ( im 1'a:htatrt I- :. 1;a:ltty-I I4 IFI y. Hu.htr IR: \latttnc tcrth.h•atval. JrM•nJrn:c. .m.l ahu.r, ut l)S\1-I\' luurrcvfb%luk• cul 1. (.Jur.l I•t \\ Idt.aer T:\• Frana•. :\ I. I'In:u. HA. First S1R• Rtl.. R. I)att. \\. \\a.hln>;ttm• 1)l. amen:an I's v:htatn: :1..IStattun. Iy`+-1. Pp Itw-I It. IFI Ilt. Hu_hc._IR: timl,krnr a. a Jrug Jept•nJrn:r:.r rrph- tl/ knhmam anJ Pnt.harJ. 1'.y:hopharnta:ulup /I+t•rl~ Ivy.;: 11 :c±~~-:S : I(;I "11. Ciovino GA. Henningfield JE, Tomar SL Escobedo LG, Slade J: Epidemiology of tobacco use and dependence. Epfdemtol Rev 1995; 17:48-65 IFI 12. FaRerstrom K. Schnetder NCi: Measuring nicotine dependence: a review of the FaFerstrom Tolerance Questionnaire. J Behav Med 1989; 12:159-182 IFI . I~. f tr~nr. IR. (lulhtcr \K. 1-rnwta. I\C'. (:ru.cr K. \•alhcrr \\':\. IR•ppt•r Sl.. Shra 1'I. Imillmtnn l.l: snulltne:c.. tnun amunl .rlt- yutttcr.. Health I'.ychnl 1`+`+_: I 1: 1;I-; :4 I(:I 14. (.uhen S. l.l.htcn.tcm k. I'nb:ha.ka It). Rn..i IS. (inti F.R. (:arr (:R• Orlran. CT. Sch/lcnha.h \'I. Rtrnrr I.. :\hr.tm. 1)• Ih('Ic- nu•nu• (:C:• (.urn S. \larlatt ("a. C:untmm); KSt. f.ntnnt SI.. (,ttwmu (1. C).,IP-I:Ictn I): I)chunkmg mwths alxwt .clt-yun- pn;;. Ani P.Ychtll IyS`+:aa:l.;::_I;ni IAI 13. Hu;;hr. /R:1)crt•nJcna• patcnnal anJ ahux• h.thilttt• of nlcottnc rcpla:cmcnt thcraptc.. RlumcJ I'hant>.ti utht•r 1 yx9; 4.;:1 I-1- I FI Ih. Huthc. JR. HIgent. ST. Hat.ukaml U: Ettc•rts of ah.tincnt:c• trum tnhac.o: acnn:al rrvtcw• In Rc•uar:h Adt•ancc.In Alcohol and I)ru}; Pruhlents, vol lu. EJItrJ by I:nzlowski I.T, Annis H\1• (:apl+cll HI). Glax•r Fit. (,t>,nl.tadt S1S• Israel Y. Kalant H. St•Ilcr. E\1, \'Inl;ib. ER. New York. Plcnum, Iy`11), pp'i17- iyx IFI I'. Hu}thec IR• Hanukamt I)l:: The ntcllttnc withdrawal svn- Jruntc: a hrict review and upJarc. Int ,1 Smoking (ASati(in 1992: 1:!1-2h IFI I%. US Ikpartment of Health and Human kn•ice.: Health Con.e- yucncc% of Smoktn); (a•satum: A Report of the US Surgeon (.cncral. \C'ashin};ron, I)C:. l1S Go.'crnment Printing Officc, 1y901F1 19. US Department of Health and Wclfare: Smoking and Health: A Report of the Surgeon GcncraL Wachrngton, l)G lIS Govern- ment I'rinnn>; Officc, 1y7y IF1 2(1. 1'ctu R. Lot+ez AI), Borcham J. Thun M, Heath C Jr: Mortality from tobacco in developed countries: indirect estimation from national vital statistics. lancct 1992; 339:126%-1278 lGI 21. Bartecchi (:F:. \1aci:enzic TD, Schner R W: The human ctKts of tohacco use, pan II. N EnFI J S1cJ 1994; 330:975-9R(/ IFI 22. US lkpartmcnt of Health and Human Services: Thc Health 26 Am J Psychiatry 1.53: 1 0, October 1996 Strpplement 51770 69,17
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3. Behavioral interventions are most effective when they include multiple components (procedures such as aversive smoking, skills training, group support, and self-reward). Inclusion of too many treatment procedures can lead to less successful out- come. 4. Nicotine replacement can reduce tobacco withdrawal symp- - totsss and may enhance the efficacy of behavioral treatment. Appendix A: Trends in Tobacco Use in the United States 1. An estimated 32.7 percent of men and 28.3 percent of women smoked cigarettes regularly in 1985. The overall prevalence of smoking in the United States decreased from 36.7 percent in 1976 (52.4 million adults) to 30.4 percent in 1985 (51.1 million adults). 2. In 1985, the mean reported number of cigarettes smoked per dav was 21.8 for male smokers and 18.1 for female smokers. 3. Smoking is more common in lower socioeconomic categories (blue-collar workers or unemployed persons, less educated persons, and lower income groups) than in higher socioeconom- ic categories. For example, the prevalence of smoking in 1985 among persons without a high school diploma was 35.4 percent, compared with 16.5 percent among persons with postgraduate college education. 4. An estimated 18.7 percent of high school seniors reported daily use of cigarettes in 1986. The prevalence of daily use of one or more cigarettes among high school seniors declined between 1975 and 1986 by approximately 35 percent. Most of the decline oc:;urred between 1977 and 1981. Since 1976, the smoking prevalence among females has consistently been slightlN • higher than among males. 5. The use of cigars and pipes has declined 80 percent since 1964. 6. Smokeless tobacco use has increased substantially among young men and has declined among older men since 1975. An estimated 8.2 percent of 17- to 19-year-old men were users of smokeless tobacco products in 1986. Appendix B: Toxicity of Nicotine 1. At high exposure levels, nicotine is a potent and potentially lethal poison. Human poisonings occur primarily as a result of accidental ingestion or skin contact with nicotine-containing insecticides or, in children, after ingestion of tobacco or tobacco juices. 2. Mild nicotine intoxication occurs in first-time smokers, non- smoking workers who harvest tobacco leaves, and people who 4
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18 room" and "rush." It produces a high lasting from a few seconds to several minutes. Young people between the ages of seven and 17 are the most common abusers of inhalants. About nine percent of young people in this country had experimented with inhalants in 1985, while only four percent were current users. These youths generally come from back- grounds reflecting family instability-separa- tion, lack of supervision, alcohol or other drug dependence. School or work adjustment prob- lems such as delinquency, truancy, poor grades, dropping out of school and unemploy- ment are also common. Occasionally, young children misuse inhalant products uninten- tionally, since they are often found around the house. Inhalants reach the lungs and bloodstream very quickly. They work in much the same way as anesthetics, which slow down the body's functions. Low doses can cause a feeling of slight stimulation; more of the substance may lead to reduced inhibitions and less control. At high doses, loss of consciousness can occur. The immediate effects of inhalants include nausea, nosebleeds, coughing, sneezing, feel- ing and looking tired, bad breath, lack of coor- dination and loss of appetite. Solvents and aerosols also decrease heart and breathing rates and affect judgment. The degree of these effects varies with the specific substance inhaled, the dose, and the personality and ex- perience of the user. More serious effects can result from deep breathing of inhalant vapors, or using large quantities over a short period of time. These effects may include loss of self control, violent behavior, losing touch with one's surround- ings, unconsciousness or death. Nausea and 19 vomiting may also occur, and if the user is un- conscious while vomiting, death from aspira- tion can result. Sniffing high concentrations of inhalant fumes can produce heart failure and instant death. Such concentrations cause death from suffoca- tion by displacing the oxygen in the lungs. In- halants can also depress the central nervous system to the point that breathing slows down until it stops. Long-term abuse of inhalants can cause fa- tigue, weight loss, electrolyte (salt) imbalance and muscle fatigue. Repeated sniffing of con- centrated vapors over several years can dam- age the liver, kidneys, blood and bone marrow, and can also lead to permanent dam- age to the nervous system, causing major physical and mental deficits. Sedative-Hypnotics Sedative-hypnotics are a group of drugs re- ferred to as tranquilizers and sleeping pills, or generally as sedatives. These drugs are used medically to relieve anxiety and promote sleep. When they are abused or taken at high doses, however, many of these drugs can lead to unconsciousness and death. Although the nonmedical use of sedatives among the 18-to-25 age group declined from 8.7 percent in 1982 to 5.1 percent in 1985, use of tranquilizers and analgesics (pain relievers) by older adults increased from 1.1 percent in 1982 to 2.8 percent in 1985. The two major categories of sedative-hypnot- ics are barbiturates-also known as "barbs" and "downers"--and benzodiazepines. All of the drugs in these groups have similar chemi- cal structures. Some commonly abused barbi- turates include amobarbital (Amytal), secobarbital (Seconal) and pentobarbital
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review of the evidence to date regarding health consequences of smoking (US DHEW 1971). The subsequent reports (1972 to 1976) continued to review the increasing evidence associating cigarette smoking with many health hazards. The 1972 Report also discussed involuntary or passive smoking (US DHEW 1972). The 1973 Report included some data on the health hazards of smoking pipes and cigars (US PHS 1973). The 1975 Report updated information on the health effects of involuntary or passive smoking (US DHEW 1975). The combined 1977-78 Report discussed smoking-related problems unique to women (US DHEW 1978). At the time of its release, the 1979 Report was the most comprehensive review by a Surgeon General's Report of the health consequences of smoking, smoking behavior, and smoking control. In addition to providing a thorough review of the health consequences of smoking, the 1979 Report discussed the health consequences of using forms of tobacco other than cigarettes (pipes, cigars, and smokeless tobacco). Moreover, the 1979 Report expanded the scope of the previous reports and examined behavioral, pharmacologic, and social factors influencing the initiation, maintenance, and cessation of cigarette smoking. Relevant to the topic of the present Report, the 1979 Report concluded that "it is no exaggeration to say that smoking is the prototypical substance-abuse dependency and that improved knowledge of this •process holds great promise for preven- tion of risk." Since the release of the 1979 Report, each subsequent Report has focused on a specific population or setting (women in 1980 (US DHHS 1980), the workplace in 1985 (US DHHS 1985)), a specific topic (health effects of low-tar and low-nicotine cigarettes in 1981 (US DHHS 1981), involuntary smoking in 1986 (US DHHS 1986a)), or a specific disease (cancer in 1982 (US DHHS 1982), cardiovascular diseases in 1983 (US DHHS 1983a), chronic obstruc- tive lung disease in 1984 (US DHHS 1984a)). In addition to the previous Surgeon General's Reports, several other developments and publications provide relevant background for the present Report. For example, numerous monographs pre- pared in the 1970s by the National Institute on Drug Abuse (NIDA) considered tobacco use as a form of drug dependence. In 1980, the American Psychiatric Association, in its Diagnostic and Statistical Manual of Mental Disorders, included tobacco dependence as a substance abuse disorder and tobacco withdrawal as an organic mental disorder (APA 1980). The 1987 revised edition of this manual (APA 1987), in recognition of the role of nicotine, changed "tobacco withdrawal" to "nicotine withdrawal." In 1982, the Director of NIDA testified to Congress that the position of NIDA was that tobacco use could lead to dependence and that nicotine was a prototypic dependence-producing drug. In a 1983 publication, "Why People Smoke Cigarettes," the U.S. Public Health Service supported this 12 posit In th a prc tobac cocah alcoh. conse Repor healtf smoke dence- The Healtl- deleter Theref unders profess and to indicat( of this Chapter macodyr 1. A11 and cigai 2. Nicod and r nicoti differ accur Thus for 2 3. Nicot brain systez absor, 4. Acute nicoti
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Introduction Development and Organization of this Report This Report was developed by the Office on Smoking and Health, Center for Health Promotion and Education, Centers for Disease Control, Public Health Service of the U.S. Department of Health and Human Services as part of the Department's responsibility, under Public Law 91-222, to report new and current information on smoking and health to the United States Congress. The scientific content of this Report reflects the contributions of more than 50 scientists representing a wide variety of relevant disciplines. These experts, known for their understanding of and work in specific content areas, prepared manuscripts for incorpora- tion into this Report. The Office on Smoking and Health and its consultants edited and consolidated the individual manuscripts into appropriate chapters. These draft chapters were subjected to an extensive outside peer review (see Acknowledgments for individuals and their affiliations) whereby each chapter was reviewed by up to 11 experts. Based on the comments of these reviewers, the chapters were revised and the entire volume was assembled. This revised edition of the Report was resubjected to review by 20 distinguished scientists inside and outside the Federal Government, both in this country and abroad. Parallel to this review, the entire Report was also submitted for review to 12 institutes and agencies within the U.S. Public Health Service. The comments from the senior scientific reviewers and the agencies were used to prepare the final volume of this Report. This Report contains a Foreword by the Assistant Secretary for Health, a Preface by the Surgeon General of the U.S. Public Health Service, and the following chapters and appendices: Chapter I. Introduction, Overview, Summary, and Conclu- sions Chapter II. Nicotine: Pharmacokinetics, Metabolism, and Pharmacodynamics Chapter III. Nicotine: Sites and Mechanisms of Actions Chapter IV. Tobacco Use as Drug Dependence Chapter V. Tobacco Use Compared to Other Drug Dependencies Chapter VI. Effects of Nicotine That May Promote Tobacco Use Chapter VII. Treatment of Tobacco Dependence Appendix A. Trends in Tobacco Use in the United States Appendix B. Toxicity of Nicotine ' 5 1_ i i .S ® f 0 < .• =f~ 3 t E . 0 0 i W'i W ~ F3 9 M © 0 x
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2.- 11ZEMURANDiTM TO: Michael Nims FROM: Harold I: Schwartz, M.D. DATE: September 5, 1995 SUBJECT: From "A Review of Empirical Studies on Informed Consent and Decision Making" in Making Healthcare Decision: The Ethical and Legal Implications of b jormed Consent in the Patient-Practitioner Relationship, Yolume II: Appendices "Empiri- cal Studies of L formed Consent" by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982. How do patient's make treatment decisions? How and to what extent is information used to make such decisions? "Most discussions of informed consent assume that information provided by physicians is used to make treatment decisions. However, very few studies have been done to determine just how patients make decisions and what the role of information is in that process. From anecdotal reports and case studies it is clear that many factors come into play in making decisions. These include previous experiences with particular treatments, personal beliefs, and, most notably, the patient's own assessment of what is best in terms of his or her own values and life plans. Such judgments may or may not coincide with physicians' judgments concerning the best medical decision and may, therefore, be seen as 'irrational' by physicians." "Faden and Beauchamps have conducted virtually the only study of the relative influence of a number of factors on treatment decisions. Study subjects who were given information about non-surgical contraception were questioned afterward about their decisions. Although the information given by the doctor was'useful', only 12% reported that the information was'the most important factor' in deter- mining the decision. Personal feelings and past experiences were more often the determining factors." ~OEIOSIiION 9 "
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"Psychological Issues in Informed Consent" by William C. Thompson In analyzing the various elements which contribute to the failure to draw appropriate conclusions from disclosed information the author highlights the issue of the misunderstanding of base-rate information, i.e. information about the likelihood of a given event among members of a certain category or class and the over-valuation of case information, i.e. consisting of examples, anecdotes and single instances. "A great deal of recent work in the decision literature has studied people's use of base-rate and diagnostic information in various contexts. The general finding is that people tend to ignore base-rate information and focus most of their attention on diagnostic information. ...under use of base-rates is frequent, pervasive and quite likely to lead patients to erroneous conclusions in many cases. Nor are they the only ones to be misled. Doctors appear to misuse base-rate information also. One recent study of doctors' skills at identifying disease found they systematically overused information from diagnostic tests and under used base-rates, especially when attempting to diagnose low base-rate diseases like cancer." In contrast, "Striking examples, vivid case studies, and the like are typically observed to have far greater influence on people's inferences than normative models say they deserve. A basic limitation on people's ability to use information rationally is their tendency to act as if examples were proof." "Third, research in cognitive psychology suggests that the mental procedures our brains adopt for processing information have certain built in biases that operate to exaggerate the impact of vivid, memorable information on our inferences." (Conversely, warning which are based merely on statistical probabilities would not tend to have this effect.) The author also focuses on "framing effects". People's choices are often influenced by the way the alternatives are presented or "framed". "Framing effects are important because they reveal logical inconsistencies in people's use of probablistic information." Interpreting doctors' linguistic expressions of probability "One additional difficulty patient's face in assessing the risks and benefits of medical interventions is understanding the terms doctors use to convey estimates of likelihood. Doctors often fail to express risks in terms of numerical probability, preferring to use linguistic expressions. But are these linguistic terms intelligible to patients? When the doctor says a certain benefit is'likely' or'probable' or'ex-
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ould have ceased to exist" -damaging effects of tobac- ;hout the 17th and 18th termine the chief active the oily essence of tobacco ?lin. This active substance ot, who sent tobacco seeds md of the 16th century. In sity of Heidelberg isolated iamed it "Nikotin." The , was determined in the i the 1890s (Robert 1949). pharmacologic actions of asic information about the 1980). The classic work by ne's effects in autonornic zals transmit information )tors on cells that respond iemicals. As early as the ! concluding that nicotine )f tobacco products (Arm- 1931). Johnston (1942) :ially a means of adminis- a means of administering has continued to investi- The 1964 Report of the Smoking and Health (US se of tobacco is related s, reinforced and perpetu- ne on the central nervous A materials do not satisfy habit." The 1964 Report, longer made) between serted that tobacco was :nction in 1964 between -nphetamines) and addict- rates) was based on: (1) dependence; (2) whether (habituating drugs) or to :rength of the habitual estion at the time of the pharmacologic agent for •ed to be more similar to 3 and barbiturates. Later in 1964 the World Health Organization dropped this semantic distinction between habituating and addicting drugs because it was recognized that habitual use could be as strongly developed for cocaine as for morphine, that social damage generally accompanied personal damage, and that behavioral characteristics of drug use could be similar for the so-called habituating and addicting drugs. In an effort to shift the focus to dependent patterns of behavior and away from moral and social issues associated with the term addiction, the term dependence was recommended. It is now clear that even by the earlier distinction in nomencla- ture, cigarettes and other forms of tobacco are addicting and actions of nicotine provide the pharmacologic basis of tobacco addiction. The term "dependence producing" may also be used to describe cigarettes and other forms of tobacco use, analogous to actions of other drugs (e.g., opiates, cocaine). Since 1964, considerable additional evidence has been compiled that substantiates these conclusions. The present Report reviews this information and the relevant literature. Previous Surgeon General's Reports provided current reviews of the health consequences of cigarette smoking particularly relevant to public health. For example, despite the accumulating evidence, in the early 1960s there was little recognition by the public of the health hazards of smoking. Each Report examined specific informa- tion considered to be important for public disseniination. A brief review of topics addressed in these reports provides the background for the present Report. In the late 1950s, the U.S. Public Health Service, the National Cancer Institute, the National Heart Institute, the American Cancer Society, and the American Heart Association appointed a study group to examine the available evidence on smoking and health. This study group concluded that excessive cigarette smoking is a causative factor in lung cancer. In 1962, Surgeon General Luther Terry established an advisory committee on smoking and health. This committee released its Report on January 11, 1964, concluding that cigarette smoking is a cause of lung cancer in men and a suspected cause of lung cancer in women, and increased the risk of dying from pulmonary emphysema. The next Report was issued in 1967 (US PHS 1968a) and stated that "the case for cigarette smoking as the principal cause of lung cancer is overwhelming." Further, the 1967 Report concluded that: "There is an increasing convergence of many types of evidence ... which strongly suggests that cigarette smoking can cause death from coronary heart disease." The 1967 Report also concluded that "Cigarette smoking is the most important of the causes of chronic non-neoplastic bronchopulmonary disease in the United States." - The 1968 and 1969 Reports (US PHS 1968b, 1969) strengthened the conclusions reached in 1967. The 1971 Report provided a detailed 11
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Non-Compliance Excerpts from Improving Medicatioii Compliance Adherence to Doctors' Advice Compliance Rate Weight Reducing Diet 20% KidneyDisease Diet 28% Hemodialysis 70% Prohibition of Smoking 29% A number of examples are provided: Prophvlaxis again heart attacks: "Non-compliance with drugs that reduce the risk of heart attack may emerge as a major problem as these drugs come into more widespread use." One study has shown that "Compared with controls, drug treated patients had an 11% de- crease in low density lipoprotein cholesterol (LDL) and a 19% reduction in risks from coronary heart disease (CHD), a non-fatal heart attack. But in this study compliance was poor - at the end of the seventh year, 27% of the participants were consuming no drug. It was calculated that if the patients in this study had adhered completely to the drug regimen, LDL would have been reduced to 35%. According to the authors this would correspond to a 49% reduction in CHD risk. Thus, non-compliance reduced by more than half the capacity of this agent to prevent heart attacks. ... denial of the occurrence and significance of heart attacks which is common among post-MI patients, may contribute to low compli- ance with prophylactic agents against second heart attacks." Hypertension: "Hypertension is the most frequently studieD disease with regard to compliance. It has been estimated that 60 million people in the United States have high blood pressure. Education and screening programs have greatly reduced the number of people who are unaware that they have hypertension. But more than 50% of hypertensive patients have been reported to drop out of therapy during the first year, and of the remainder, nearly 33% do not take enough of their prescribed medications to lead to an adequate reduction of blood pressure. All-in-all, fewer than 30-50% of hypertensiveS under treatment have their blood pressure under effective control." "Many studies have shown a strong correlation between compliance with anti-hypertensive
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J MEMORANDUM TO: Michael Nims FROM: 'Harold T: Schwartz, M.D. DATE: September 5, 1995 SUBJECT: Non-Compliance The literature on non-compliance with physician prescribed medication regimens has bearing on the central question of why patients do not follow doctors' recommendations. The following excerpts are from Improving Medication Compliance: Proceedings of a Symposium of the National Pharmaceutical Counsel, Washington, DC, November 1984. Keynote Address: C. Everett Koop "In survey after survey, run by the FDA, by the industry, and by interested con- sumer groups, the results are always the same: a substantial number of patients - 20% and more - do not fill their prescriptions or don't take medicines even after the prescriptions have been filled." From "Therapeutic Consequences of Non-Compliance", Craig D. Burrell and Richard A. Levy "The incidence of compliance with drug therapy for many important diseases is 50% or less. Compliance is even lower for long-term treatment and for diseases without symptoms." "Compliance with treatment has emerged as a major public health problem, influencing the quality and outcomes of medical care. Inadequate compliance occurs over a wide variety of treatment recommendations, including appointments, diets, exercise and the avoidance of smoking." "On the average, 50% of all patients fail to comply with prescribed medication regimens; compliance is even lower for long-term treatment and for diseases without symptoms." "Non-compliance is common in patients of all ages and across a wide range of diseases. There is no correlation with age (except for the very young and very old), sex, socioeconomic status, or level of education." From a table entitled "Adherence to Doctors' Advice": 96 ~ ~m evuaff 3
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dolescents first beginning a number of unpleasant ; chronic tobacco use. anisms of Actions c agent that acts in the ns include electrocortical and cardiovascular and iical and electrocortical to reinforce tobacco use. or receptors throughout crosses the blood-brain .iortly after it enters the :h specific receptors and tern consistent with the or the drug. early all components of !ms (including catechol- itary hormones). Some . by actions of nicotine 3 (e.g., hypothalam- zas direct peripherally -~dulla and the adrenal idence addicting. Patterns of e, and a withdrawal abstinence. ses addiction. Specifi- altering") and can serve as a reinforcer tsing behavior. Toler- h that repeated use be accompanied by )hysical dependence iat usually accompa- elivery systems can refore, new nicotine or their toxic and i Chapter V: Tobacco Use Compared to Other Drug Dependen- cies 1. The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. 2. Environmental factors including drug-associated stimuli and social pressure are important influences of initiation, patterns of use, quitting, and relapse to use of opioids, alcohol, nicotine, and other addicting drugs. 3. Many persons dependent upon opioids, alcohol, nicotine, or other drugs are able to give up their drug use outside the context of treatment programs; -other persons, however, re- quire the assistance of formal cessation programs to achieve lasting drug abstinence. 4. Relapse to drug use often occurs among persons who have achieved abstinence from opioids, alcohol, nicotine, or other drugs. 5. Behavioral and pharmacologic intervention techniques with demonstrated efficacy are available for the treatment of addiction to opioids, alcohol, nicotine, and other drugs. Chapter VI: Effects of Nicotine That May Promote Tobacco Dependence 1. After smoking cigarettes or receiving nicotine, smokers per- form better on some cognitive tasks (including sustained attention and selective attention) than they do when deprived of cigarettes or nicotine. However, smoking and nicotine do not improve general learning. 2. Stress increases cigarette consumption among smokers. Fur- ther, stress has been identified as a risk factor for initiation of smoking in adolescence. 3. In general, cigarette smokers weigh less (approximately 7 lb less on average) than nonsmokers. Many smokers who quit smoking gain weight: 4. Food intake and probably metabolic factors are involved in the inverse relationship between smoking and body weight. There is evidence that nicotine plays an important role in the relationship between smoking and body weight. Chapter VII: Treatment of Tobacco Dependence 1. Tobacco dependence can be treated successfully. 2. Effective interventions include behavioral approaches alone and behavioral approaches with adjunctive pharmacologic treatment. 15 a~ o'
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MEMORANDUM TO: Michael Nims FROA1: ' Harold I. Schwartz, M.D. DATE: September 5, 1995 SUBJECT: Improving Medication Compliance "A Critical Review of Interventions to Improve Compliance with Special Reference to the Role of Physicians" by R. Brian Haynes. In Improv»rgMedicatiwi Compliw2ce: Proceedings of a Symposium of the Natimral Pharmaceutical Cowrsel, Washington, DC, November 1984. This chapter focuses on the models for understanding non-compliance and crafting interventions to improve compliance. The author discusses the information model. "The basic tenet of the information model is that patient's fail to comply because they lack sufficient information about the risks of their disease, the benefits of treatment, and/or the details of the treatment regimen. It is believed that supplying the patient with appropriate information will lead, in sequence, to correct know- ledge, attitudes, and most importantly, behaviors that insure adequate compliance. The information approach is important because most practitioners believe in it. For example, in Logan's survey (1978) of general practitioners, 74% of respon- dents used instructions to gain their patients' long-term compliance with anti- hypertensive treatment." "Table 1 summarizes the results of over 100 studies, mainly descriptive in nature, that have examined factors that relate to the information model. If this approach were correct one would expect the IQ and educational level of the patient, as well as his or her knowledge of the disease and its treatment, to effect compliance. The evidence suggests otherwise; 70% of the studies found no such relationship." "A better test of the model comes from controlled clinical trials in which attempts were made to improve compliance by increasing patient knowledge through instruction or counselling." . "Table 2 summarizes the results of 19 such clinical trials. Fifty-three percent of the studies found no benefit and one study (Swain and Steckel, 1981) even found harm from instruction. In this study, the dropout rate from anti-hypertensive care was significantly increased among patients who received the series of educational
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so dreadful as stated the human race would have ceased to exist" (Lancet 1857). While the health-promoting and health-damaging effects of tobac- co products were being debated throughout the 17th and 18th centuries, scientists were trying to determine the chief active ingredient in tobacco. In the early 1800s the oily essence of tobacco was discovered by Cerioli and by Vauquelin. This active substance was named "Nicotianine," after Jean Nicot, who sent tobacco seeds from Portugal to the French court at the end of the 16th century. In 1828, Posselt and Reimann at the University of Heidelberg isolated the pure form of Nicotianine and renamed it "Nikotin." The chemical's empirical 'formula, C,oH„NZ, was determined in the 1840s, and "nicotine" was synthesized in the 1890s (Robert 1949). Since the late 1800s, research on the pharmacologic actions of nicotine has contributed substantially to basic information about the nervous system (Kharkevich 1980; Volle 1980). The classic work by Langley and Dickinson (1889) on nicotine's effects in autonomic ganglia led to the postulates that chemicals transmit information between neurons and that there are receptors on cells that respond functionally to stimulation by specific chemicals. As early as the 1920s and 1930s, some investigators were concluding that nicotine was responsible for the compulsive use of tobacco products (Arm- strong-Jones 1927; Dorsey 1936; Lewin 1931). Johnston (1942) concluded that, "smoking tobacco is essentially a means of adminis- tering nicotine, just as smoking opium is a means of administering morphine." Throughout the 20th century, research has continued to investi- gate the role of nicotine in tobacco use. The 1964 Report of the Surgeon General's Advisory Committee on Smoking and Health (US PHS 1964) held that: "The habitual use of tobacco is related primarily to psychological and social drives, reinforced and perpetu- ated by the pharmacologic actions of nicotine on the central nervous system. Nicotine-free tobacco or other plant materials do not satisfy the needs of those who acquire the tobacco habit." The 1964 Report, relying upon a distinction (that is no longer made) between "habituating" and "addicting" drugs, asserted that tobacco was habituating and not addicting. The distinction in 1964 between habituating drugs (including cocaine and amphetamines) and addict- ing drugs (including opiates and barbiturates) was based on: (1) whether the drug produced clear physical dependence; (2) whether damage was mainly to the individual user (habituating drugs) or to society (addicting drugs); and (3) the strength of the habitual behavior that developed. There was no question at the time of the 1964 Report that nicotine was the critical pharmacologic agent for tobacco use, but its role was then considered to be more similar to cocaine and amphetamines than to opiates and barbiturates. Later 10 in 1964 t distinctior recognizec cocaine as personal c could be si an effort i away fror addiction, It is no% ture, cigar of nicotine term "dep and other (e.g., opiat has been c Report re, Previou: the health to public h the early health haz tion consic review of t for the pr In the 1. Cancer Ins Society, ai group to e This study causative : In 1962, committee Report on • cause of lu: women, anc The next Rc "the case fo is overwhelr is an incre2 strongly sl coronary t "Cigarette non-neopla The 196f the conclus
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ost effective when they include -es such as aversive smoking, ,id self-reward). Inclusion of too .n lead to less successful out- ce tobacco withdrawal symp- cacy of behavioral treatment. ;e in the United States n and 28.3 percent of women )85. The overall prevalence of -creased from 36.7 percent in percent in 1985 (51.1 million ber of cigarettes smoked per nd 18.1 for female smokers. :er socioeconomic categories yed persons, less educated than in higher socioeconom- ~valence of smoking in 1985 ,ol diploma was 35.4 percent, ; persons with postgraduate chool seniors reported daily alence of daily use of one or -1 seniors declined between percent. Most of the decline Since 1976, the smoking :onsistently been slightly :ned 80 percent since 1964. :sed substantially among older men since 1975. An ?ar-old men were users of a potent and potentially ir primarily as a result of with nicotine-containing tion of tobacco or tobacco first-time smokers, non- ) leaves, and people who chew excessive amounts of nicotine polacrilex gum. Tolerance to these effects develops rapidly. 3. Nicotine exposure in long-term tobacco users is substantial, affecting many organ systems (Chapters II and III). Pharmaco- logic actions of nicotine may contribute to the pathogenesis of smoking-related diseases, although direct causation has not yet been determined. Of particular concern are cardiovascular disease, complications of hypertension, reproductive disorders, cancer, and gastrointestinal disorders, including peptic ulcer disease and gastroesophageal reflux. 4. The risks of short-term nicotine replacement therapy as an aid to smoking cessation in healthy people are acceptable and substantially outweighed by the risks of cigarette smoking. 17
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24 Drug Abuse Publication No. 87-1427. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1987. Daley, Dennis C. SurvivingAddictions. New York: Gardner Press, 1987. Franks, Lucinda. 'A New Attack on Alcoholism." New York Times Magazzine, October 20,1985, pp. 47-67. Highlights of the 1985 National Household Survey on Dn.tgAbuse. U.S. Department of Health and Human Services, National Institute on Drug Abuse, NIDA Capsules. Rockville, Maryland: Press Office of the National Institute on Drug Abuse, 1986. Inhalants. U.S. Department of Health and Human Services, National Institute on Drug Abuse Publication No. 83-1307. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1983. Ketcham, Kathy and Ann Mueller. Recover New York: Bantam Books, 1987. Marijuana. U.S. Department of Health and Human Services, National Institute on Drug Abuse, NIDA Capsules. Rockville, Maryland: Press Office of the National Institute on Drug Abuse, 1986. Marlin, Emily. Hope. New York: Harper & Row, 1987. Myers, Judy. Staying Sober New York: Congdon & Weed,1987. O'Gorman, Patricia A. and Philip Oliver-Diaz. Brealdng the Cycle ofAddiction. Pompano Beach, Florida: Health Communications, 1987. Opiates. U.S. Department of Health and Human Services, National Institute on Drug Abuse, Publication No. 84-1308. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1984. Perez, Joseph F. Relationships. New York: Gardner Press, 1987. Position Statement on Psychoactive Substance Use and Dependence: Update on Marijuana and Cocaine. Washington, DC: American Psychiatric Association, 1987. 25 Russell, George K. Marijuana Todav: A Compilation of Medical Findings for the Layman. New York: Myrin Institute for Adult Education, 1978. Sedative-Hypnotics. U.S. Department of Health and Human Services, National Institute on Drug Abuse, Publication No. 84-1309. Washington, DC: Superintendent of Documents, U.S. Government Office of Printing, 1984. Spickard, Anderson and Barbara R. Thompson. Dving for a Drink Waco, Texas: World Books, 1985. When Cocaine Affects Someone You Love. U.S. Department of Health and Human Services, National Institute on Drug Abuse, Publication No. 88-1559. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1987. 0ther Aesources Alcohol and Drug Abuse Problems Association of America, Inc. 444 North Capitol Street, N.W, Suite 181 Washington, DC 20001 (202) 737-4340 Alcohol, Drug Abuse, and Mental Health Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 443-3783 American Academy of Child and Adolescent Psychiatry 3615 Wisconsin Avenue, N.W. Washington,D.C. 20016 (202) 966-7300 American Academy of Psychiatrists in Alcoholism and Addictions PO Box 376 Greenbelt, Maryland 20770 (301) 220-0951 American Council on Drug Education 136 East 64th. Street New York, NY 10021 1-800-488-DRUG
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ME111OTUNDU111 TO: Michael Nims FROINT: Harold I. Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Self-efficacy and Motivation Since much of the literature on motivation for change in behavior such as smoking is found in the self-efficacy literature, following is an excerpt from Bandura who has been responsible for much of the original thinking in this area. "Self-efficacy: Toward a Unifying Theory of Behavioral Change." Bandura, Albert Psychologi- cal Revrew 1977, Vol. 84, No. 3, pp 191-215. "It is hypothesized that expectations of personal efficacy determine whether coping behavior will be initiated, how much effort will be expended, and how long it will be sustained in the face of obstacles and aversive experiences. ...in the proposed model, expectations of personal efficacy are derived from four principle sources of information: performance accomplishments, vicarious experience, verbal persua- sion, and physiological states." "Motivation, which is primarily concerned with activation and persistence of behavior, is also partly rooted in cognitive activities. The capacity to represent future consequences in thought provides one cognitively based source of motiva- tion. Through cognitive representation of future outcomes individuals can gener- ate current motivators of behavior." "A second cognitively based source of motivation operates through the intervening influences of goal setting and self-evaluative reactions (Bandura, 1976b, 1977). Self-motivation involves standards against which to evaluate performance. By making self-rewarding reactions conditional on attaining a certain level of behav- ior, individuals created self-inducements to persist in their efforts until their performances match self-prescribed standards. Perceived negative discrepancies between performance and standards create dissatisfactions that motivate corrective changes in behavior. Both the anticipated satisfactions of desired accomplishments and the negative appraisals of insufficient performance thus provide incentives for action. Having accomplished a given level of performance, individuals often are no longer satisfied with it and make further self-reward contingent on higher attain- ments."
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0 Self-efficacy and Smoking Cessation 3 "Self-efficacy was related to the three stages of cessation studied, but its role varied across stages. In addition, self-efficacy was found to increase over the course of treatment, among those who made attempts, but not among non-at- tempters. ... When a multivariate approach was adopted, maintainers were found to have higher self-efficacy than late relapsers." "Health locus of control was found to be significant in understand- ing making an attempt and end of treatment abstinence but relation- ships were only revealed using multivariate analyses. ... Consistent with previous research (Sutton, 1989), both behavioral expectation variables were directly related to making a quit attempt and were the strongest contributors to discriminating between attempters and non-attempters."
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seeking and drug-taking behavior is driven by strong, often irresisti- ble urges. It can persist despite a desire to quit or even repeated -attempts to quit. Such behavior is also referred to as "habitual" behavior. To distinguish drug dependence from habitual behaviors not involving drugs, it must be demonstrated that a drug with psychoactive (mood-altering) effects in the brain enters the blood stream. Furthermore, drug dependence is defined by the occurrence of drug-motivated behavior; therefore, the psychoactive chemical must be capable of functioning as a reinforcer that can directly strengthen behavior leading to further drug ingestion. Additional criteria are often used to help characterize drug dependence. Several are associated with the drug-taking behavior itself: (1) the behavior may develop into regular temporal and physical patterns of use (repetitive and stereotypic); (2) drug use may persist despite adverse physical, psychological, or social conse- quences; (3) quitting episodes are often followed by resumption of drug use (relapse); (4) urges (cravings) to use the drug may be recurrent and persistent, especially during drug abstinence. Similar- ly, several common effects of dependence-producing drugs can strengthen their control over behavior and increase the likelihood of harm by contributing to the regularity and overall level of drug intake: (1) diminished responsiveness (tolerance) to the effects of a drug occurs, and may be accompanied by increased intake over time; (2) abstinence-associated withdrawal reactions (due to physical dependence) can motivate further drug intake; (3) effects that are considered pleasant (euphoriant) to the drug user can be provided by the drug itself. Dependence-producing drugs can also produce effects that individuals find useful. For example, many addicting drugs have therapeutic uses in medical treatments of various disorders. Most medically approved drugs that are addicting, however, are generally only available by prescription. Effects of a drug considered by the individual to be useful can promote initiation of drug use, strengthen the addiction, and contribute to relapse following cessa- tion of use. Tobacco and nicotine are considered in the Report in light of the above criteria. In brief, the organization of the Report is as follows: review of evidence that tobacco use is accompanied by orderly patterns of uptake of nicotine in the body and brain resulting in the development of tolerance (Chapter II); review of how effects of nicotine in the brain and the rest of the body are chemically mediated (Chapter III); review of the evidence that tobacco is addicting and that nicotine is an addicting drug (Chapter IV); comparison of tobacco use with other addictions and of nicotine with other addicting drugs (Chapter V); review of possible effects of nicotine that may promote the use of tobacco and present impedi- ments to quitting smoking (Chapter VI); review of strategies for hel VIi tiot reg the Maj Brie Tc was use Thei diar• Eurc color econ( To: throL As u: of tht the vi. others exhort can't -s conder contir medic In 1 of 50 creasE visual convir propol some I
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MEMORANDUM TO: Michael Nims FROM: Harold I: -Schwartz, M.D. DATE: September 5, 1995 I SUBJECT: Abstract of "Psychological Issues in Informed Consent" by William C. Thompson in Making Health Care Decisions: The Legal and Ethical Implications of In- formed Consent in the Patient Practitioner Relationship, Volume 3: Appendices "Studies on the Foundations of Informed Consent" published by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, October 1982. In his review of psychological issues in informed consent Thompson focuses on numerous issues, including how people use information which is disclosed to them by physicians. He focuses on how people assess risks which are disclosed to them. "I will base this argument on psychological research showing that people's risk assessments are strongly influenced by the form and manner in which information about risks is presented. Information with the same objective content can lead people to strikingly different conclusions when it is presented in different ways." He notes the general finding in the informed consent literature that patients often fail to remember and perhaps fail to understand what they have been told. "This literature on human decision making and judgment now comprises literally thousands of studies. Perhaps the major conclusion that can be drawn is that there are striking inadequacies in the way people use information to make judgments and to draw inferences. One major reviewer of the literature concluded that'Human decisions are characterized by biases and inconsistencies that can lead to markedly non-optimal behavior.' Another conclusion is that People systematically violate the principles of rational decision making when judging probabilities, making predictions or otherwise attempting to cope with probablistic tasks.' These findings have resulted in'an increased concern with the deficiencies of unaided human judgment, deficiencies that seem to result from a limited ability to integrate complex information.'" "Seemingly minor variations in the way information is presented can often have a dramatic effect on the conclusions and inferences people draw from it. ...further- more the accuracy of the conclusions people draw from information varies with the nature of the information and the manner in which it is presented." [ ; ~ l ~ 's~ ~'s o nuor m.r ~eCz.? 0
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irding health consequences of =equent reports (1972 to 1976) evidence associating cigarette ~'he 1972 Report also discussed )HEW 1972). The 1973 Report azards of smoking pipes and -t updated information on the •e smoking (US DHEW 1975). ;ed smoking-related problems 1979 Report was the most eneral's Report of the health :vior, and smoking control. In v of the health consequences the health consequences of garettes (pipes, cigars, and :1eport expanded the scope of avioral, pharmacologic, and maintenance, and cessation ,ic of the present Report, the exaggeration to say that Lbuse dependency and that s great promise for preven- 79 Report, each subsequent ition or setting (women in 1985 (US DHHS 1985)), a 3 low-nicotine cigarettes in )king in 1986 (US DHHS i 1982 (US DHHS 1982), _S 1983a), chronic obstruc- 84a)). ;eneral's Reports, several vide relevant background merous monographs pre- te on Drug Abuse (NIDA) dependence. In 1980, the )iagnostic and Statistical obacco dependence as a thdrawal as an organic ed edition of this manual cotine, changed "tobacco ,82, the Director of NIDA DA was that tobacco use Aine was a prototypic blication, "Why People Service supported this i f position of NIDA regarding tobacco and nicotine (US DHHS 1983b). In the 1984 NIDA Triennial Report to Congress, nicotine was labeled a prototypic dependence-producing drug and the role of nicotine in tobacco use was considered to be analogous to the roles of morphine, cocaine, and ethanol, in the use of opium, coca-derived products, and alcoholic beverages, respectively (US DHHS 1984b). In 1986, a consensus conference of the National Institutes of Health and the Report of the Advisory Committee to the Surgeon General on the health consequences of using smokeless tobacco concluded that smokeless tobacco can be addicting and that nicotine is a depen- dence-producing (i.e., addicting) drug (US DHHS 1986b). The present Report is the 20th such report issued by the Public Health Service on the health consequences of tobacco use. The deleterious effects of cigarette smoking are now well known. Therefore, this Report focuses on pharmacologic information to help understand why people smoke. Such information will assist health professionals in developing effective strategies to prevent initiation and to promote cessation. The literature reviewed in this Report indicates that tobacco use is an addictive behavior. It is the purpose of this Report to thoroughly review the relevant literature. Chapter Conciusions In addition to the three overall conclusions of this Report, there are many other substantive conclusions. These points are listed under the appropriate Chapter and Appendix headings. Chapter II: Nicotine: Pharmacokinetics, Metabolism, and Phar- macodynamics 1. All tobacco products contain substantial amounts of nicotine and other alkaloids. Tobaccos from low-yield and high-yield cigarettes contain similar amounts of nicotine. 2. Nicotine is absorbed readily from tobacco smoke in the lungs and from smokeless tobacco in the mouth or nose. Levels of nicotine in the blood are similar in magnitude in people using different forms of tobacco. With regular use, levels of nicotine accumulate in the body during the day and persist overnight. Thus, daily tobacco users are exposed to the effects of nicotine for 24 hr each day. 3. Nicotine that enters the blood is rapidly distributed to the brain. As a result, effects of nicotine on the central nervous system occur rapidly after a puff of cigarette smoke or after absorption of nicotine from other routes of administration. 4. Acute and chronic tolerance develops to many effects of nicotine. Such tolerance is consistent with reports that initial
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Whv Smokers Ignore Warnings they do not regard themselves as 'hea.,%' smokers. ignoring the fact that the relationship between dose and risk is a linear one. «'e have also noted that most current smokers are smoking 'light' cigarettes with reduced tar and nicotine . content; perhaps they regard this as reducing or eliminating the risk. Some smokers seem convinced that they will stop smoking some time in the future before the harmful effects appear. More research is needed on the specific cognitive defenses against the anxiety that should be generated by the acceptance and even exaggeration of the health risk."
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MEMORANDUM TO: Michael Nims FROM: Harold I. Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Self-efficacy and Smoking Cessation There are numerous articles in the literature which have found a relationship between self-efficacy and smoking cessation. While one finds debates in the literature about distinctions between "self- efficacy" and "outcome expectation" and further debates about the predictive ability of low self- efficacy, medium self-efficacy, and high self-efficacy and their differential impact on lapse and relapse, the central take home message is that one's expectation of success influences outcome, that positive or negative outcome further influences expectations (self-efficacy) which have further influence on outcome and so on. Haaga DA and Stewart BL. Self-efficacy for recovery from a lapse after smoking cessation. Journal of Corrsulting and Clinical Psychology 1992, Vol 6d, No. 1, 24-28. In this study high, mode:ate and low self-efficacy subgroups were created by dividing a sample of recent ex-smokers in thirds on a measure of self-efficacy regarding relapse. These subgroups were compared with respect to the speed with which they resumed smoking if at all in the year after quitting. "Post-treatment self-efficacy (operationalized as confidence in one's ability to avoid smoking in high risk situations) consistently predicts maintenance'of smoking cessation (Baer and Lichtenstein, 1988b). Thus, there is clearly a general positive relationship between SE and smoking cessation maintenance." In this study "recent ex-smokers who articulated thoughts reflecting a moderate level of self- efficacy regarding relapse sustained abstinence during the following year to a greater degree than did their more confident or less confident counterparts, though this difference was significant only with respect to the less confident subgroup." (Those with the highest self-efficacy had a non-statistically significant greater degree of relapse than those with moderate self-efficacy. The authors attribute this to a certain degree of over confidence on the part of these individuals with regard to their ability to bounce back from a lapse.) Additional self-efficacy articles:
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Self-efficacy and Motivation "In this conceptual system, expectations of personal mastery effect initiation and persistence of coping behavior. The strength of people's convictions in their own effectiveness is likely to effect whether they will even try to cope with given situations." "Not only can perceived self-efficacy have directive influence on choice of activi- ties and settings, but, through expectations of eventual success, it can effect coping efforts once they are initiated. Efficacy expectations determine how much effort people will expend and how long they will persist in the face of obstacles and aversive experiences. The stronger the perceived self-efficacy, the more active the efforts." Bandura addresses the question, why would two people having similar mastery experiences nevertheless develop different efficacy expectations for the future? "One possible explanation for the variances in terms of differential cognitive processing of efficacy information. To the extent that individuals differ in how they cognitively appraise their arousal decrements and behavioral attainments, their percepts of self-efficacy will vary to some degree. A second possibility concerns the multiple determination of self-efficacy. Because people have met with different types and amounts of efficacy altering experiences, providing one new source of efficacy information would not be expected to effect everyone uniformly." In order words, individuals bring a baseline generalized sense of personal efficacy in the world to the specifics of any particular task which they face. Their generalized sense of self-efficacy in conjunction with their perceived sense of self-efficacy regarding the particular task both influence outcome.
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s MEMORANDUM TO: Michael Nims FROM: 'Harold 1. Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Motivation and Social Supports Hill HA, Schoenbach VJ, Cleinbaum DG, Strecher VJ, Orleans CT, Gebsky VJ and Kaplan BH. A longitudinal analysis of predictors of quitting smoking among participants in a self- help intervention trial. Addictive Behaviors, Vol. 19. No. 2, pp 159-173, 1994. "While much of the previous work in smoking cessation research has focused on demographic and smoking history variables, results of this study indicate that emphasis should also be placed on psychosocial/motivational factors and quitting activities as important predictors of abstinence. Subjects were adult smokers belonging to a health maintenance organization who responded to an offer of free quitting assistance. Self-reported smoking status was assessed at 8, 16, and 24 months following enrollment." The sample consisted of 2,021 smokers belonging to Group Health Cooperative of Seattle, Washington. "Following baseline data collection and informed consent, subjects were randomized to one of four groups: three intervention groups received various quitting aids, and a control group was given a resource guide describing available self-help materials and formal treatment program." The results indicated that "Support from family, friends and co-workers, and confidence in one's ability to become a non-smoker were highly significant predictors of seven day abstinence in this population, as were having set a quite date, having previously quit for over 90 days, being married, and perceiving weight control as a serious problem. Also positively related to abstinence were: randomization to the maximum intervention group, not having consumed five or more alcoholic drinks on a single occasion during the past month (i.e., binge drinking), higher education, and past use of a self-help cessation treatment." "Several factors related to nicotine dependence and smoking history were con-
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I MEMORANDUM TO: Michael Nims FROM: Harold 1. Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Articles on Issues Related to Motivation Hall SM, Havasy BE, Wasserman DA. Commitment to abstinence and acute stress in relapse to alcohol, opiates, and nicotine. Journal of Cwunlting and Clinical Psychology 1990, Vol. 58, No. 2, pp 175-181. "The importance of commitment, and the broader construct of motivation, to treatment outcome has been emphasized in the literature on addictive disorders (C. Brownell, et al, 1986; Janis, 1983; Miller, 1985). " "Other dimensions of commitment, studied primarily in cigarette smokers, include the desire to abstain, expectation of success, and expected difficulty of quitting (Best, 1975; Mothersill, McDowell, and Rosser, 1988; Rosen and Shipley, 1983). Related constructs are perceived costs and benefit of change (Hall, 1980; Hall, Rugg, Tunstall, and Jones, 1984) and self-efficacy (Annis and Davis, 1988; Condiotte and Lichtenstein, 1981)." Of note, these authors state that "Although withdrawal symptoms have been associated with relapse, confirmatory evidence is lacking." "The following hypotheses were proposed: 1) Commitment to absolute absti- nence will decrease the risk of the first slip. ... 3) Commitment to absolute absti- nence will predict a longer time between the first slip and relapse. In exploratory analyses, we examined the effects on drug use of three other dimensions of commitment to abstinence: desire to quit, expected success, and perceived diffi- culty." "A major finding of our study was that return to drug use for clients in treatment for alcohol, opiate and nicotine dependence is predictable from their abstinence goal. Subjects with the most restrictive goals, absolute abstinence, were less likely to slip and less likely to relapse after a slip than subjects with less demanding goals. This relation held independent of drug group."
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Self-efficacy and Smoking Cessation Broad NII and Hall SH. Joiners and non joiners in smoking treatment: a comparison of psycho- social variables. Addictive Behaviors, Vol. 8, pp 217-221, 1984. This study attempts to discriminate what leads individuals to either join or not join a smoking cessation program following a single visit for an orientation session. A personal sense of self- efficacy was the single most important discriminating factor as to who joins the stop smoking program. "Formal treatment programs are an important contribution to smoking cessation. Unfortunately, all smokers who express an interest in joining programs do not enter treatment. Though smokers who decide not to enter treatment represent a substantial population who have traditionally been'lost' to researchers, more must be learned about how they differ, if at all, from smokers who enter treatment. ... It was hypothesized that smokers who enter treatment will have higher self-efficacy scores than smokers who do not." "The hypothesis that smokers who enter treatment programs will have a higher self-efficacy score than those smokers who do not enter treatment was supported. ... The characteristics of the non joiner have been identified. He or she is more anxious and has a lower self-efficacy expectation than the treatment joiner." Stewart K, Borland R, McMurray Nancy. Self-efficacy, health locus of control, and smoking cessation. Addictive Behaviors, Vol. 19, No. 1, pp 1-12, 1994 "This article examines the predictive value of measures of health locus of control and self-efficacy as predictors of outcomes of a widely disseminated group facilitated smoking cessation program. ... Both pre-treatment self-efficacy and health locus of control variables emerged as significant predictors of making an attempt and end of treatment abstinence. Only post-treatment self-efficacy predicted maintenance at six months. The results indicate that high self-efficacy is inversely related to making attempts to quit, but positively related to the success of attempts." Health locus of control is a measure which reflects the degree to which one believes that a central locus of control with regard to one's health is within the individual as opposed to outside of the individual, in the hands of others. Individuals with high health locus of control tend to believe that their thoughts and actions will have a large influence on their health. Those with low or . external health locus of control tend to believe that the thoughts and actions of others are more important in this regard. "The present study found that self-efficacy and health locus of control (HLC) beliefs were predictors of aspects of the process of smoking cessation, but gener- ally only in multivariate analyses."
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Articles on Issues Related to Motivation "But in our study, subjects with a goal of absolute abstinence were significantly less likely to relapse than those with other goals. This was true for subjects who experienced a slip as well as for the entire sample." "Indeed, in a post talk analysis we found that subjects who endorsed absolute abstinence conditionally (i.e., allowing for the possibility of future slips) actually fared worse than those who endorsed the goal unequivocally. Among subjects who slipped at least once, 43% of those with the strictest possible goal eventually relapsed, versus 77% of subjects who accepted the possibility of slips. ... When data from the entire sample were analyzed, we found that 54% of the subjects with a more rigorous goal relapsed as compared to 80% of those who accepted the possibility of slips." "Negative moods, life events, hassles and symptoms failed to interact with absti- nence goal in predicting either relapse or the time between the first slip and relapse." Walton MA, Castro FG, Barrington EH. The role of attributions in abstinence, lapse and relapse following substance abuse treatment. Addictive Behaviors, Vol. 19, No. 3, pp 319-331, 1994. "This study examined the role of attributions in the lapse and relapse process following substance abuse treatment." Note that participants in this study were recovering from abuse of cocaine and methamphetamine and, thus, conclusions with regard to smokers are by inference. "Success in avoiding temptation to return to the use of substance (complete abstinence) was associated with making internal, stable, and specific attributions. Thus successful participants perceived their abstinence as being 'caused' or effected by ks ills or bili i to resist temptation, and that these abilities are influenced across situations and across time. It appears that abstinence affords the recovering substance user a sense of empowerment over substances." In other words, there is a relationship between success in abstaining and those individuals who assume or accept personal responsibility by making internal rather than external attributions with regard to their abstinence and relapse behaviors. "Regarding the dimension locus of causalitv, there was one significant group contrast; the abstinent group exhibited higher internal scores as compared with the lapse group. Thus, the abstainers strongly attributed their success in avoiding relapse to themselves. By contrast, the lapsers were more ambivalent regarding the cause of their use as indicated by their attributions scores ... "
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Motivation and Social Supports -t "Personal support is an important resource enabling a person to cope with different minor and major stressful situations in daily life (Hansen and Ostergren. 1987). The individual can act in different ways in order to cope with these stressful* situations and thereby decrease the discomfort and stress caused bv these situations. The social support of the individual represents an expansion of the individual's own resources, by means of which he can cope with these stressful situations in a more rational way and thereby possibly prevent, for example. relapses in smoking." "The proportion of former smokers was also higher among those men having angina pectoris and treatment for hypertension. This indicates that people who get ill are more prone to quit smoking for good. The physician should therefore use this opportunity to give the patient a better support in order to increase the likelihood that the patient stops smoking for good." [One can infer that equivalent support/advice provided to healthier persons has been less effective in influencing smoking behavior.] "In this study availability of emotional support, mostly operationalized through items on the availability of close friends and relatives (other than spouse) had an independent association to smoking cessation and maintenance of cessation. Other studies show that former smokers at one year follow-up of a smoking cessation program had better spousal support, but also better social support from parents, other family and friends (Horwitz, et al, 1985). In a study of hospitalized cardiovascular patients, social support (encouragement to quit smoking) given by close friends and family members explained the greatest difference between smokers and former smokers (Gianetti, Reynolds. and Rihn. 1985). In a community sample from Israel (Westman, e1 al, 1985) successful abstainers had in comparison to smoking men, a higher level of social support from immediate co-workers. This social support measure did assess both emotional and material support. In the Almeida.County study (Berkman and Syme, 1979) an association was found between former smoking and the social network index. The index included marital status, contacts with close friends and relatives and church and group membership."
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Addictive Disorders, Alcoholism, Smoking and Obesity emotional states are related to relapse. With regard to inadequate motivation they write, "It is surprising that so little work has been done on motivation and commitment. It would seem that all persons who set out to change are motivated, particularly those who enter professional programs. However, there are degrees of motiva- tion, and it is common for a person to begin the change process in a burst of enthusiasm without appreciation for the long-term effort involved. In other cases, the motivation may be more external than internal, when social pressure forces a symbolic if not real attempt to change." "There are three relevant aspects of the motivation issue. The first is the need to evaluate motivation so that high risk subjects can be detected. To our knowledge this has not been done in the addictions area. Second, screening for motivation is important if treatment should be targeted at those with a chance of success. Third, methods may be available for increasing motivation. ..." With regard to coping skills the authors write, "Shiffman (1984) found that both cognitive and behavioral coping responses were associated with success in smokers calling the hotline mentioned earlier. The most common behavioral responses were consumption of food and drink and other distracting activities. Several aspects of'sel.f-talk' were the most common cogni- tive responses." The authors review the physiological factors at play in relapse, i.e., the reinforcing effect of nicotine. They relate these factors to intrapersonal and social influences. "Given these important physiological factors, it may be informative to examine the subjective impressions of their likely manifestations, namely cravings, urges, and withdrawal. Studies in these areas have shown inconsistent findings. The Cumming, et al (1980)'study found that 'urges and temptations' were associated ' with only 6% of the relapse situations and that'negative physical states' were associated with only 7% of the situations. Mermelstein, et al (1983) found that craving was the major factor in only 9% of relapses in smokers. In contrast, Shiffrnan (1982) found that approximately half of the relapse situations in smokers occurred in conjunction with withdrawal symptoms." In his article Shiffman noted his interpretation that this finding indicated that withdrawal symp- toms are less important than expected. "Support from family and friends is one of the. few variables that is associated with long-term success at weight reduction (Brownell, 1984a; Miller and Sims, 1981;
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/D MEMORANDUM TO: Michael Nims FROM: Harold I: Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Why Smokers Ignore Warnings Zuckerman M, Ball S, Black J. Influences of sensation seeking, gender, risk appraisal, and situational motivation on smoking. Addictive Behaviors. Vol. 15, pp 209-220. 1990. This study has produced a finding of great interest with regard to the question off why individuals, informed and knowledgeable about risks (perhaps even overestimating risks of smoking), nevertheless, continue their smoking behavior without change. "A high percentage of subjects estimated the health risk in smoking to be 'very great,' including 63% of those who quit smoking and 38% of those continuing to smoke. The risk was considered small to moderate in only 13% of past smokers and 25% of current smokers. Sensation seeking was not related to this general risk appraisal in either past or current smokers." "The chances of heavy smokers developing lung cancer was estimated about the same by past and current smokers. About half of the smokers in both groups estimated the proportion of heavy smokers who would develop lung cancer as 50% and about a third od the subjects estimated the risk at 35%. No response options were offered above 50% but informal surveys in other classes suggested that most subjects believed the risk to be in excess of 50%. These risk estimates were not significantly related to sensation seeking in either past or current smokers." In the discussion section the authors review this finding. "We had hypothesized that high sensation seekers would minimize the risks of smoking while lows would exaggerate them. What was surprising was the very high risk appraisal of smoking even among those continuing to smoke. But despite this acceptance of risk in smokers in general there was no evidence that this was more true for high sensation seeking smokers than for lows." "How can smokers continue to smoke despite their own estimates of high risk in the activity? Perhaps most of the smokers do not feel at personal risk because
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MEMORANDUM TO: Michael Nims FROM: Harold I. Schwartz, M.D. DATE: September 10, 1995 SUBJECT: Alcoholism, Smoking and Obesity: Commonalities ~ rtAlN> ~~ ON ~ Brownell KD, Marlatt GA, Lichtenstein E, Wilson, GT. Understanding and preventing relapse. American Psychologist 41:765-782, 1986. "Some information does exist on the natural history of the addictions. Vaillant's (1983) report on the long-term progress of 110 alcohol abusers, 71 of whom were 'alcohol dependent,' shows the complexity of the issue. Vaillant's book, and an article by Vaillant and Milofsky (1982), showed the importance of cultural and ethnic factors in alcoholism. Many personal and environmental factors influence the propensity to drink excessively." "Schachter (1982) interviewed 161 persons from the Psychology Department at Columbia University and from a resort community. In their retrospective ac-" counts, they reported much higher rates of success at dieting and smoking cessa- tion than suggested by the literature. Almost all success were achieved without professional aid. Although Schachter's methods have been questioned (Jeffrey and Wing, 1983; Prochaska, 1983), he made several important points. He noted that cure rates are based on clinical samples and that self-quitters may differ from therapy-assisted quitters, a notion supported by DeClemente and Prochaska (1982). Second he found that many of the successful quitter had made numerous attempts to change before finally succeeding." The author's review the attempts of several researchers to develop models of the stages of quitting. "More work is needed to test the utility of the various stage models. They are similar in many respects. Each has at least one stage where motivation and commitment are central, followed by initial change and then the maintenance of change, so we will use these three fundamental stages to organize the description of relapse prevention..." In a section in the article on individual and intrapersonal factors [in relapse] the authors review negative emotional states, inadequate motivation, response to treatment and coping skills. With regard to negative emotional states they emphasize that stress, depression, anxiety and other
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Factors «'hich Discriminate Quitters from Non-quitters with an Emphasis on Motivation and Commitment ex-smokers. ... Social support for cessation measured as the degree of disapproval of smoking by the respondents social network and belief in susceptibility to the smoking- disease linkage were the factors which most highly differentiated smokers and ex- smokers am6ng the respondents." "The findings in this study seem to indicate that continued reinforcement to quit smoking from the respondent's social network and a strong perception of the linkage between smoking and disease account for the major proportion of the difference between smokers and ex-smokers." "This study offered some limited support for the health belief/behavior model and confirmed the importance of social network support for the discontinuance of smok- 11 ing. "For the sample of cardiovascular patients, it seems likely that the decision to quit smoking was an important function of direct social network support for cessation, a strong perception of the negative health effects of smoking, and a general perception of the benefits exceeding the costs of cessation."
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Addictive Disorders, Alcoholism, Smoking and Obesity 3 Wilson, 1985). Studies on smoking suggest the same association (Coppotelli and Orleans, 1985; Mermelstein, et al, 1983). Whether a spouse is a smoker and is attempting.to quit relates negatively to ability to stop smoking (Lichtenstein, 1982). Perceived general support (not specific to quitting) also relates to the maintenance of non-smoking or reduced smoking (Mermelstein, et al, 1983). ... It appears, therefore, that stressful interpersonal relationships can hinder and that supportive relationships can help. This emerges from the literature despite inconsistent methods of measuring support. The supportive person may be helpful not only is establishing a benevolent environment but by assisting with specific behavior changes (Coppotelli and Orleans, 1985). One challenge is to evaluate the nature of supportive behaviors and the reasons certain behaviors support some persons and not others." Individual, environment, and physiological factors: An interaction. "The risk for lapse and relapse is determined by an interaction of individual, environmental, and physiological factors. This is an area in which the distinction of lapse and relapse is particularly useful, as there may be different determinants and antecedents in each case. Mermelstein and Lichtenstein (1983) showed in their findings that lapses tended to be associated with social factors and that relapses were associated with individual factors (negative emotional states and stress events). Shiffman (1982) theorized that a situational analysis could predict increased risk for relapse but that coping skills would determine whether this risk becomes reality." "If lapse and relapse are viewed on a time line, individual, environmental, and physiological factors may exert their influence at different stages. Physiological factors may promote lapse and may set into play a series of reactions to an initial lapse that may increase the likelihood of relapse. Environmental and social factors can provide the setting, stimuli, and encouragement from others to lapse. As the choice point for the lapse approaches, coping skills can prevent the lapse. Whether the lapse recurs and ends in relapse probably results from a complex interaction of these factors, each of which may assume more or less importance depending on the individual and his or her environment." "The object would be to screen for individual, environmental, or physiological factors that cannot be remedied easily. One factor is motivation. It is difficult to motivate a person who does not have a strong commitment to change. There are instances of programs motivating groups of people, say in a work site or commu- nity (Brownell, Cohn, Stunkard, Felix and Cooley, 1984; Pechacek, Mittlemark, Jeffrey, Loken and Luepker, 1985), but reliable methods for motivating individuals have not been developed. Another factor relates to a person's skills. Some skills deficits may be difficult to overcome."
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Improving Medication Compliance pamphlets on their condition and their role in its treatment. Nevertheless, 42% of these trials did report a positive effect of instruction on behavior." "This disagreement among studies of the effect of instruction on compliance is clarified by considering the type of compliance required. As shown in Table 3, instruction improves the success of referrals (from screening to sources of care or from one source of care to another) and of short-term medical treatments (less than one month) but has no lasting effect on long-term compliance." "The exact duration of the effect of information on compliance is not clear from these studies but it appears to average about 10 days to two weeks. This shouldn't be confused with the effect of information programs on patients' knowledge. Information is frequently retained long after compliance has fallen off (Sackett, et al, 1975)." "...in fact, to date there has been no study that has satisfactorily shown that a single intervention of any sort is sufficient to improve long-term compliance." In his discussion of the compliance activity model the author notes the role of the individual's social environment. "The third element of the compliance activity model is the social interactions of the patient. As social circumstances do effect the patient's compliance, one would expect the patients in disrupted social environments (e.g. broken families or downward social mobility), those with families who do not support their attempts to follow their treatment, or those who live in social isolation ( and thus lack social support) to comply less well than those in more favorable circumstances. As shown in Table 5, two-thirds of the studies that have examined these factors have concluded that they do have an important influence on compliance, particularly those factors having to do with family stability and support from the family for the patient." •
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Motivation and Social Supports ; "Smoking can be considered a maladaptive behavior helping the smoker to cope with discomfort generated by minor and major stressful situations in daily life (Ockeme, et al, 1981). The smoker's ability to handle such stressful situations without cigarettes is conditioned by the presence of different individual and psychosocial resources (Ockeme, et al, 1981). Individual factors like age. gender. education, psychological characteristics and health status are important determinants for successful long-term quitting (Kabat and Wynder. 1987; Tunstall, Ginsberg and Hall, 1985). Long-term success is also determined by psychosocial and environmental factors." "Some data [regarding psychosocial supports] are, however, available. Successful abstainers in smoking cessation programs have a better spousal support (Horwitz. Hindi-Alexander, and Wagner, 1985; Mermelstein, Lichtenstein and ???. 1983) and better social support from parents, family and friends (Horwitz, et al. 1985). Data from community samples show that successful abstainers have in comparison with smokers a higher level of social support from co-workers (Westman, Eden, and Shirom, 1985), and a higher social network score (Berkman and Syme, 1979). Heavy smokers have fewer friends and a lower social support from co-workers and work managers than non-smokers (Billing and Moos, 1983)." "The univariate analysis revealed a relation between former smoking and social anchorage, contact frequency and social participation. The same tendency was found for availability of emotional support ... differences were also found between the three categories of marital status. The highest proportion of former smokers were found among men cohabiting with a non-smoking woman, the lowest among men cohabiting with a smoking woman ... in the multivariate analysis availability of emotional support was independently associated to smoking cessation." "Emotional support reflects the individual's opportunity for care, encouragement of personal value and feelings of confidence and trust (Hansen, 1988). This concept was operationalized [in this study] through the following four items (no item on spousal support was included): • Do you have any friends or relatives who you like very much and who like you very much? • Do you have any really close friend with whom you feel intimate and with whom you can discuss anything? • When you have personal problems of any kind, do you have any close friend or relative to whom you can turn to discuss your problems? • If you have continued to work, is it because you want to feel that you are a valuable and important person?"
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Motivation and Social Supports sidered in this analysis, yet few emerged as predictive of abstinence. Both age at . which regular smoking was begun and total years as a smoker were eliminated at the screening stage because of none significant bivariate associations with the outcome. Pack years, exposure to cigarettes, nicotine dose (mg/day). and tar content of the usual brand were entered into the initial model but none of them proved to be a significant independent predictor of quitting." Only one item related to dependence, the Fagerstrom Tolerance Questionnaire was assessed as predictive. Other findings of note include no relationship between number of past quit attempts and success, however, having experienced at least one lengthy period of abstinence (greater than 90 days) was predictive of successful quitting. "One specific action - setting a quit date - nearly doubled the odds of achieving seven day abstinence among subjects in this study." It was noted that nicotine polacrilex chewing gum could be a useful aid but the effect was seen only in the context of specialized smoking cessation clinics (a conclusion drawn froctt a net analysis of the combined results of 14 randomized controlled studies). "High self-efficacy and the benefits of social support from family, friends. co- workers and spouses, regardless of their smoking status. were found in this analysis to be among the factors with the strongest positive influence. In contrast. desire to quit was eliminated as a potential predictor during the initial screening process. However, the effect of desire to quit may not have been assessed adequately, since the study was conducted along a select group of subjects, that is. those who were motivated enough to enroll in the cessation program." "While a great deal of past smoking cessation research has focused on the impact of demographics and smoking history on quitting success, many of the independent predictors df seven day abstinence in this study had to do with psychosocial/ motivational factors or with quitting activities." Hansen BS, Isacsson SO, Janzon L, Lindell SE. Social support and quitting smoking for good. Is there an association? Results from the Population Study, "Men Born in 1914," Malamo, Sweden. Addictive Behaviors, Vol. 15, pp 2? 1-233, 1990. This is a rather remarkable study which demonstrates a profound relationship between social and emotional support and quitting smoking for good. This study is but one of many which flow from a very large project, following a cohort of men born in Malamo, Sweden in 1914. The study was designed to evaluate various risk factors for cardiovascular and pulmonary diseases and has generated numerous findings in wide ranging areas of related medical practice.
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1Z MEMORANDUM TO: Michael Nims FROM: Harold I. Schwartz, M.D. DATE: September 17, 1995 SUBJECT: Factors Which Discriminate Quitters from Non-quitters with an Emphasis on Motivation and Commitment Marlatt GA, Curry S and Gordon JR. A longitudinal analysis of unaided smoking cessation. Journal of Consulting and Clinical Psychology 56:715-720, 1988. "A sample of 153 smokers who attempted to quit smoking without treatment was followed for two years. ... A strong motivation to quit was found to be important for both initial success and long-term treatment." "Gritz, Carr and Marcus (in press) conducted a one-year follow-up study of over 500 smokers who either made a New 1'ear's resolution to quit or who quit in response to the Great American Smoke Out sponsored by the American Cancer Society. ... Compared with relapsers, those who were successful at one year were less dependent smokers who were highly motivated to stop, were confident of their ability to do so, and were committed to quitting." "This study shows that individuals who attempted to quit smoking on their own are reasonably successful. The outcome percentages compare favorably with existing quit rate data. The 26% median success rate for aided quitters reported by Schwartz (1987) is similar to what we found for unaided quitters (24°/0) at one year." "The importance of motivation associated with initial cessation is highlighted by the fmding that participants who were successful in initial quitting reported a significantly higher desire to quit than that reported by never quitters. In addition, among those who were successful in initial quitting, those who remained abstinent at the two year follow-up indicated a significantly higher desire to quit than those who relapsed." Rosen TJ and Shipley RH. A stage analysis of self-initiated smoking reductions. Addictive Behav- iors 8:263-272, 1983. "This study predicted self-initiated smoking reductions in 61 regular smokers. 'Desire to stop predicted the decision to reduce smoking, self-esteem predicted initial smoking reduction, and the combination of internal health locus of control beliefs and strong desire to stop predicted successful maintenance of reduction."'
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MEMORANDUM TO: Michael Nims FROM: Harold I. Schwartz, M.D. DATE: September 17, 1995 SUBJECT: For Medical Advice to be Effective. Individuals Must Be In a State of Readiness to Act Upon Advice Prochaska JO, DiClemente CC, and Norcross JC. In search of how people change: Applications to addictive behaviors. .=imerican Psychologist 47:1102-1114. September 1992. In this article the authors elaborate a model for personal change which they have developed in the literature previously. This model applies specifically to change for individuals experiencing addictive behaviors. The model outlines five stages of change. These include: precontemplation. contemplation, preparation, action and maintenance. In the early stages, precontemplation and contemplation, individuals are not yet ready to take action for change. "The vast majority of addicted people are not in the action stage. Aggregating across studies and populations (Abrams, Follick. and Biener, 1988; Gottlieb, Galavotti, McCuan and McAllister, 1990; Pallonen. Fava, Salonen, and Prochaska. in press). 10% to 15%b of smokers are prepared for action, approximately 30°•o to 40°o are in the contemplation stage, and 50% to 60% are in the precontemplation stage. If these data hold for other populations and problems, then professionals approaching communities and work site with only action oriented programs are likely to underserve, misserve or not serve the majority of their target population." The implication of this model is that merely providing advice to individuals who are not yet in the action stage is largely ineffective. In this model, individuals would have had to go through pre- contemplation and contemplation (in which they begin to think about taking action), to preparation (in which they actually begin to prepare themselves for action) in order to be in a position to be much affected by advice giving. "A person's stage of change provides proscriptive as well as prescriptive information on treatments of choice. Action oriented therapies may be quite effective with individuals who are in the preparation or action stages. These same programs may be ineffective or detrimental, however, with individuals in precontemplation or contem- plation stages." "An intensive action and maintenance oriented smoking cessation program for cardiac patients was highly successful for those patients in action stage and ready for action. This same program failed, however, with smokers in the precontemplation and contemplation stages (Ockene. Ockene and Kristellar, 1988)." d rLApIiIFfS OE~SITION ILE'~
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\'1COTI\T DEPENDENCE 6". Hun RD. Eherman l:\l. Siadc 1D. l:aran L: Treannc ruconnr addiction in patients Nltn otner addimce dtsoroersf in Ni.onnr Adji:non: Pnn,ariei and \lanacemen:. Edited rv Oriean, CT. Siade JD. Ne%x York. Oxford L'niverscn Press. 1Q°:. pp +lt- 326 IFJ -0. Prochaska /0. DtClemenre CC. \'eiicer ViF. Rossi IS: Stand- ardized. individualized. interactive and personalized selt-hrir programs tor smoking cessation. Health Ps}-chol 1993; 1=:3ay- -t05 JAI -1. Schwartz JL: Methods of smoking cessanon. Med Clin North am 199?:'6:4>1-i 6-(E) -'. Schwartz JL: Review and Evaluation of Smoking Cessation methods: The United States and Canada. Vi ashtnt:ton. DC. US Department of Health and Human Services. 195- JE) -3. Gntz ER. Kristeller JL. Burns D\1: Treating nicotine addiction in high-risk groups and patients with medical co-morbidity, in \iconne Addiction: Principles and \fanagement. Edited by Or- ieans CT. Slade JD.':ew York. Oxford Universtn• Press. 1993, pp 2'9-309 (F) '4. Lando HA: Formal quit smoking treatments. lhid, pp 2? 1-2;4 (F) -5. Cinciripini P\l. Lapitsky L Seay S- Vi'allfisch A. Kitchens l:: The effects of smoking schedules on cessation outcome: can we tm- proce on common methods of gradual and abrupt nicotine H•tthdrawal: J Consult Clin Psychol 1995: 63:385-399 );t,) 76. French SA, Jeffery Ru': Weight concerns and smoking: a ittera- ture review. Ann Behav \1ed 1993: 1':234--244 IF] ". Gritz ER. l:lesges RC. Meyers AW: The smoking and body weight relationship: implications for intervention and post-ces- sarion weight control. Ann Behav Med 1989; 11:144-153 )F) 'S. Hall SM. Tunstall CD. Vila KL. DuffyJ: Weight gain prevention and smoking cessation: cautionary hndings- Am J Public Health 1992; 82:799-803 JAI 79. Pirie PL. McBride CM. Helierstedt W. Jeffery RVt', Hatsukami DK. Allen S. Lando H: Smoking cessation in women concerned about weight. Am J Public Health 1992; 82:1238-1243 JAI 80. McBride CM. French SA. Pirie PL, Jeffrey RW: Changes over time in weight concerns among women smokers engaged in thr cessation process. Ann Behav \fed nn press) JAI 81. Perkins KA: Issues in the prevention of.veight gain after smok- ing cessation. Ann Behav Med 1994; 16:46-52 1 F) 82. Shiffman SM: Relapse following smoking cessation: a situ- ational analysis. J Consult Clin Psychol 1982; )C) 83. Hughes JR, Olivero AH: Caffeine and alcohol intake as predic- tors of smoking cessation and tobacco withdrawal. J Subst Abuse 1993; 5:305-310 ICI 84. Oliveto AH. Hughes JR, Terry Sl'. Bici:cl WK. Higgins ST. Pep- per SL, Fenwick JV(': Effects of caffeine on tobacco withdrawal. Clin Pharmacol Ther 1991: 50:1 .5--164 JAI 85. Hughes JR: Caffeine withdrawal, dependence. and abusr, in DSM-IV Sourcebook, vol 1. Edited by Widiger TA. Frances AJ. Pincus HA. First MB, Ross R. Davis W. Washington. DC. American Pspchiatnc Association_ 1994, pp 129-134 )F) 86. Kenford SL, Fiore MC, Jorenby DE. Smith SS, Wetter D. Baker TB: Predicting smoking cessation: who will quit with and with- out the nicotine patch. JAMA 1994: 2'1:i89-394 ICI S'. Curry SJ: Self-help interventions for smoking cessation. J Con- sult Clin Psychol 1993: 61:790-803 IFJ 88. Brown RA, Goldstein MG. Niaura R. Emmons KM. Abrams DB: Nicotine dependence: assessment and management. in Psy- chiatric Care of the Medical Patient. Edited by Stoudemirr A. Fogel BS: New York, Oxford University Press, 1993, pp 877- 901 IF/ 89. Fisher EB Jr. Lichtenstein E, Haire-Joshu D. Morgan GD. Reh- berg HR: Methods, successes, and failures of smoking cessation programs. Annu Rev Med 1993; 44:481-513 (FJ 90. Glasgow RE, Lichtenstein E: Long-term effects of behavioral smoking cessation interventions. Behavior Therapy 1987; 18: 297-324 IF) 91. Mermelsrein RJ. l:arnatz 7`, Reichmann S: Smoking. in Princi- ples and Practice of Relapse Prevention. Edited by Wilson PH. New York, Guilford Press. 1992, pp 4348 IF] 92. Viswesvaran C, Schmidt FL: A meta-anal.tic comparison of the 28 .j.^. i~. .~. l.urr% 5. M:Fn.ic C: Rriat••r n,- r. .... ~. ,.,... . rrcir.r and rvaiuanon o: ;un:rrt, an,c t^:en Pui`it; Hcaith 111,14. 1!:?4;- 3,ot^ ' F 14-t. (,ruder CL. \lrrmel>tetn R1. kir:rrw„' !~. H..iekcr 1`. K:. >:nrr:i:rnca.: J. \\ arnrct.c RS- huara K. Nhim-- 1 teas o; cis;tai support and reiapsr rrr%rnnur. t-.acnn; a• .i, iun:t> to a teirvise.i smuian4:rs.anor. rnur.ena,a:. I%, r::•;:.7 Clin Psv,hu! 1'" '-: 01:11?-1_0 I.a' 9:. Hat ass~v B. Hill ). \\as.rrman h: <urrvo^ an,: rc:ar•: commnnaiinr!- amunc nr:at: u•rr, an,: smoi:ers..addi:t Frhas 1"yl: it.- 9t+. Cnrn E. \l:Fall K: l:r:rv.mc rrr%rnnor trn th: r.rarmrn: v: cu:arette smoking. Addict P+ehav lQ>a: -:4i);-40: ;.ii 9-. Lowe \l. Green L. i:urtx b, asheni~rrL Z. Fnnc: F:l: srlt-innl ated. cue exnmtton- and :ovrrt een.rnzanun rru;r,iurr• ic smoking ccssanun. J Brhac \Icd I IISO: IA ; 9S. Raw M. Jan•is M. Frverabrnd C. Russrll MAH: l umpan•arr of mconne chewing gum and psv,huluzt;al trratmrnt% rur dc- pendentsmokrri. Br Mcd I 1`+8tl:=S1:a81-0_ IBI 99. Ra.v M. Russell MAH: Rapid snt..ktnt. cue r\p<1.urr and .ur- port in the modification ot smoking. tkhac Re. Thcr I y8V: 1 a: 36?-:-: JAI 1110. Davis RM: The delivery ot smoktng :rs.atton srru;rs: current status and tuturr nrcds. Tobacco Control IF: 101. Hughes JR: Pharma.otherap~ fr.r smoking :rssanon: umah- dated assumpnons. anomalies and suggrsnons tor turthrr rr- srarrh. J Consulr Clin Pscchol Iy`+3: t+l:'31--u0 IEI 102. Dictusto E. Bird KD: Matching smoker% tn treatment: srlt-crm- trol versus social support. J Consult Clin I's>•chol 199:; 6 3;_9lL _95 JAI 103. Zelman DC. Brandon TH. JorenM• DE. Baker TB: Measurrs ot affea'and nicotine dependence predict differential response to smoking cessation treatmrnts. J Cunsult Clin Psvchol 1992; 60: 9a ;-95' 1 a ( 104. Gould Rr1. Clum GA: A meta-analysis of srlf-help treatment approaches. Clin Psvchol Rev 1993; 13:16'1-186 )E) 105. Lichtenstrin E. Glasgow RE. Lando HA. Osstp-Kletn DJ: Tele- phone counseling for smoking cessation: rationale and revrcw of evidence. Health Education Rrs 1yyt+; 1 I:243-25- (FI 106. Orleans CT, 5chnrnharh \'I. Wagner EH. Quade D. Salmon MA. Pearson DC. Firdlrr.l. Porter CQ. Kaplan BH: Self-help quit smoking tntrrvrnnons: rfte:ts of srli-help materials. social support instructions and telephone counseling. J Consult Clin P>vcho! 1`191: ?y:4iv-i-/8 JAI 10-. COMMIT Research Gruup: Community mtervrntion trial for smoking cessation IC:C)\1\11T1. II: chanl;es in adult ctl;arette .moking prrvalrmc. Am J Public Health 1995; 8S:19t-200 JAI 108. 5trechrr \'J, 1Crruter M. Den BtK•r I)/, l:ahrin S. Haspcrs HJ. Skinner CS: The rffrcts ut compurer-tailored smoking cessation messages in tamih- practice settings. J Fam Pract 1994; 39:262- 2-0)aI 109. Haiek P. Brlchrr M. Stapleton J: Enhancing the impact of groups: an evaluation of two group formats for smokers. Br J Clin Psvchol 198.i; 24:28y-294 JAI 110. Casey IC: lf Only I Could Quit: Recovering From Nicotine Ad- diction. Center City. Minn. Hazrldcro Foundation, 1987 )G) 1 I 1. Marcus BH. Albrrcht AE. Niaura RS. Abrams DB. Thompson PD: Usefulness of physical exercise for maintaining smoking cessation in women. Am J C ardiol 1991: 68:406-4U7 /A) 112. Marcus BH. Albrrcht AE. Niaura RS. Taylor ER, Simkin LR, Feder SI. Abrams DB, Thompson PD: Exercise enhances the maintenance of smoking cessation in women. Addict Behav 1995; 20:87-92 [A 1 113. Hughes JR: Treatment of nicotinc dependence, in Pharmaco- logical Aspects of Drug Dependence: Toward an Integrative Neurobehavioral Approach: Handbook of Experimental Psy- chology Series, vol. 11. Edited by Schuster CR. Gust SW, Kuhar MJ. New York, Springer-Verlal„ 1996, pp 599-618 1 FI 114. Jarvik ME. Henningfield JE: Pharmacological adjuncts for the treatment of tobacco dependerxe, in Nicotine Addiction: Prin- Am] Psychiatry 153:10, October 1996 Supplement 51770 6919
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Factors Nk'hich Discriminate Quitters from Non-quitters with an Emphasis on Motivation and Commitment "Baer, Foreyt and Wright (1977) found 45% of a sample of ex-smokers (all of whom had quit without professional help) spontaneously mentioned motivation to quit when asked to list the techniques they had used in quitting." In this study "...there was no evidence that emotional factors effected relapse. Instead, people who resisted relapse tended to be both internal in health locus of control and highly desirous of stopping." "Related interactions between control beliefs and motivation have been observed before. Both Wallston, Maides, and Wallston (1976) and Wallston, Wallston, Kaplan and Maides (1976) found medical information seeking was greatest among subjects who had internal beliefs and highly valued their health; Kaplan and Cowles (1976) found such subjects were the only ones to maintain smoking reductions more than four months past clinic treatment. The interactions support Rotter's statement (1985) that behavior is a joint function of both outcome expectancies and the perceived value of outcomes." Gritz ER, Carr CR, Marcus AC. Unaided smoking cessation: Great American Smoke Out and New Year's Days Quitters. Journal of Psychosocial Oncology 6:217-234, 1988. "A prospective study was conducted on 554 smokers in two cohorts (Great American Smoke Out and New Year's Day) who intended to quit smoking on their own without formalized external aid ... continuous abstainers were lighter smokers, less addicted. more aware of the health risks associated with smoking, more highly motivated to stop, more confident of their ability to do so, and more committed to quitting at baseline than other subjects." "In our study, participants who had high levels of self-efficacy before quitting were more likely to be continuous abstainers at one year. Because they received no treatment, their self-e$icacy scores reflect natural, unmodified estimates of self- confidence regarding cessation and thus accurately reflect the long-term outcome." "Finally the continuous abstainers prepared for the effort to quit by making a commit- ment to abstinence and by changing to a healthier lifestyle. Relapsers, on the other hand, were more prone to change their environment - that is, to get rid of ashtrays and cigarettes - a stimulus control strategy that proved to be ineffective." Giannetti VJ, Reynold J and Rihn T. Factors which differentiate smokers from ex-smokers among cardiovascular patients: A discriminant analysis. Social Science and Aledicine 20:241-245, 1985. "A retrospective analysis of smoking behavior among hospitalized, cardiovascular patients was conducted in order to describe factors which differentiate smokers from
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0 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK MARY ANN HOSKZNS; as Executrix ) under the Last Will and Testament ) of EDWIN PAUL HOSKINS, deceased, ) WALTINA BROWN, and DANTE AUBAIN, ) individually, and on behalf of ) others similarly situated, ) - against - Plaintiffs, . Index No. 110951/96 Hon. Charles E. Ramos Part 53 R.J. REYNOLDS TOBACCO COMPANY, ) ow RJR NABISCO, INC., COUNCIL FOR ) TOBACCO RESEARCH-USA, INC. ) (Successor to Tobacco IndustrY ) 1 INSTITUTE, INC., . EXHIBIT Research Committee) ANb TOBACCO ) s Defendants. DEFENDANT R.J. REYNOLDS TOBACCO COMPANY'8 RESPONSE TO PLAINTIFFS' INTERROGATORIES RELATED TO CLASS CERTIFICATION AND MOTIONB TO DISMISS Pursuant to CPLR 3101 and 3133, defendant R.J. Reynolds Tobacco Company ("Reynolds") responds to Plaintiffs' , Interrogatories Related to Class Certification and Motions to Dismiss ("plaintiffs' interrogatories") as follows: I. GENERAL RESPONSES AND RECURRING OBJECTIONS Reynolds makes the following general responses and recurring objections to plaintiffs' interrogatories. The recurring objections set forth below are`incorporated into each of Reynolds' responses to plaintiffs' specific interrogatories. A. Plaintiffs' Interrogatories Are Irrelevant To Class [`prtification, Under the Court's case management order signed on November 12, 1996, the scope of discovery is currently limited to the issue of class certification. Plaintiffs, however., have not
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tailored their interrogatories accordingly. Contrary to this Court's order, many, if not virtually all, of plaintiffs' interrogatories seek information wholly irrelevant to class certification: For example, Interrogatory No. 29 seeks information regarding the retail price of Reynolds' cigarettes; Interrogatory No. 51 asks Reynolds to identify every research project it has ever funded regarding nicotine and smoking behavior; Interrogatory No. 60 asks Reynolds to identify all correspondence with the Tobacco Institute on nicotine ."addiction"; and Interrogatories No. 62 and 63 inquire about Reynolds' employee health insurance and1substance abuse policies. Such requests go far beyond the issue of class certification and, to the extent they seek any relevant information, could be relevant only to the merits of plaintiffs' claims, not the grounds for class certification under CPLR 901 and 902. Reynolds, therefore, objects to each such interrogatory. B. Plaintiffs' Interrogatories Are Overbroad. Reynolds objects to plaintiffs' interrogatories on the grounds that they: (a) are overbroad; (b) are vague, ambiguous, and fail to describe with reasonable particularity the information or documents sought; (c) seek information that is neither relevant to the subject matter of this case nor reasonably calculated to lead to the discovery of admissible evidence; and (d) impose undue burdens that far outweigh the probative value of the information sought. Reynolds' objections are based, in part, on the fact that plaintiffs' interrogatories CLUTOI Doc: iM90 : 2
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purport to seek information wholly irrelevant to the issue of class certification. C. Plaintiffs' Interrogatories Ask Improper Hypothetical Ouestions. Several of plaintiffs' interrogatories ask Reynolds to answer hypothetical questions premised upon what plaintiffs claim are various definitions of the term "addiction" (see, e.g., Int. Nos. 35-41). These interrogatories necessarily ask Reynolds to accept plaintiffs' erroneous (and incongruent) statements of fact as true in formulating its response. Reynolds objects to these interrogatories on the ground that such hypothetical questions are improper and may be posed only to an expert witness, not to a party in interrogatories. Such interrogatories are not only unduly burdensome, confusing, and harassing, they are an illegitimate method of fact discovery. D. Plaintiffs' Interrogatories Are More Properly Directed To Other Defendants. Plaintiffs' counsel have made no effort to tailor their discovery to individual defendants. Indeed, counsel served the same identical set of interrogatories not only on every defendant in this action, but on every defendant in four other purported class actions against cigarette manufacturers that they have filed in this Court. As a result, many of plaintiffs' interrogatories seek information from entities other than Reynolds and/or from entities that are not parties in this case. For example, Interrogatory Nos. 64-70 (among others) seek information more appropriately obtained from the Council for Tobacco Research-U.S.A., Inc. and the Tobacco Institute. CWTOI Doc: 299290 t 3
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The Relationship of Physiological and Psychological Factors: 2 Withdrawal Symptoms "The present study examined whether smokers with greater tobacco intake, higher nicotine/cotinine levels, and shorter half-life for nicotine would have more severe tobacco withdrawal symptoms. In general, the results from this study show inconsis- tent relationships between the various measures of nicotine intake and measures of tobacco withdrawal. This finding occurred despite the use of repeated blood sampling, and the use of well validated and objective measures of nicotine intake (Benowitz, 1973; Pickens, et al, 1983) and of withdrawal symptoms (Hatsukami, Hughes and Pickens, in press)." "Our findings showing that some tobacco withdrawal symptoms are related to nicotine levels and other are not may indicate that some withdrawal symptoms are due to nicotine deprivation and others to different factors (i.e., extinction of an intense habit or reinforcers). Further tests of determinants of tobacco withdrawal are important not only to understand the wide variability of withdrawal discomfort among smokers, but also to determine the specific factors that effect specific symptoms of withdrawal. Awareness of these factors may help determine the most appropriate treatment (nicotine replacement and/or behavioral) to effectively deal with the various symptoms of withdrawal." Shiffman S. Relapse following smoking cessation: A situational analysis. Journal of Consulting and Clinical Psychology, Vol. 50, pp 71-86, 1982. "In a study of relapse process in ex-smokers, data on the antecedents of relapse crises (actual or near lapses in abstinence) were collected from 183 ex-smokers who called a relapse counseling hotline. ... Withdrawal symptoms played a lesser role than ex- pected: half of the episodes occurred in the absence of symptoms."
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- . APPENDIX B Present occupation/profession. :• 0 same as above 0 retired 0 Other 1.11 Highest level of educatioa -~- 1.12 Reason for visit with Nicatiae Dependence Consultatiori Seivice•" .. • • ' ~ - .... . • . .. -T'. . . 1.13 Referring doctor 415 2. Smokina History Age 2.1 How old were you when you first smoked a cigarette? 2.2 How old were you when you tir5tstarted regular daily cigarette smoking?._ Ciprrttesfday ?.3 On a.erage, hoK• many cig,artttcsa:c yvu currerulysmoking perday•' ?.~ O~>> :~e pas: s:.= R''ontRs, how many cigarettes did you smoke per day' __ -Dn t`:e a~c;age crric2ertirztirrre;:ou 'r,a~esrrokede how many cizareaes cid y,:u s~:.oke }z; dav' _.6 a•hc~ .s.ro%:in,r ti!e heavtrst. huw many cigarettes did you smoke per day? r Do you inhale civarette srnoke? 0 Never 0 Sometimes O Always - List brands of cigarettes smoked: Starting brand Currcnt brand Please check the appropriate boxes Smoke a pipe? Never C1 past Only O CurrentJy c O ~ Smoke cigars? O O O i Chew snuff ' 0 0 O ~ . ~ Chew tobacco? O O. O Smoke other non-tobaeeo products? 0 O O 2.10 When do you smoke the heaviest?--Check one answer. 0 Mornings C3 Afternoons O Eveniags 2.11 tiow soon after you wake up do you smoke your 6rst cigarette? O Immediately O Within 30 minutes . - _ . , O Between 30 minutes and 1 hour C] Beyond 1 hour ~-L . . 2.12 W'hich cigarette would be the most difficult to-give up? Check one answer. , O First in the morning _. tO Atter meals
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. ~~ •- ...~ .. .' . APPENDIX A.~:1 ;_ Fagerstro••m Test for Ni-cotine Dependence=-- ITEMS AND SCORING FOR FAGERSTROM TEST FOR NICOTINE DEPENDENCE QUGS'tloAs t. How soon aftcr Yvu wake up do you smoke vour first ci¢a,:ae^ :. Do you finc :t cimcuit to r=frain from scr.oking ir, ptaces .wiere it is forbidden, re.g., in church. at ti:e Iibra:y, in cinema, etc.? r 3. Which cigarette wo1ld you hate most to give up? 4. How many cigarettes/day do you smoke? 5. Do you smoke more frcquendy during the first hours after waking than during the rest of the day? 6 Do you smoke if you are so ill tlutt you are in bed most of the day? Proposed Scvring Cut-Offs 0-2 3-4 5 6-7 8-10. Sw.ae AdepMd lrom FaarsuaQn. Y / 69( l 1 },763-767, 1991. rl~swers • Poi,rrs Within 5 minutes 3 6-30 minutes , .. 3 I-F.0 minates .After 60 Ttiautes ; ~ Yes *No 0 The first one in the 1 morning All others 0 I O or less 0 11-20 1 21-30 2 31 or more 3 Yes I No 0 Yes 1 No 0 Very Low' Low Medium IL"gh (Heavy) Vety Higb O.. H..ri.n.w. T. F. lGdo." L T. NqCetlat aadusioa and in asemest F.N lrefr 77r'm ft ~ tLANIt ~~®Er06tT19N 0 m v m m
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APPENDIX B ~ . .. - .. ' • 7.. 4.3. Pjmcab eyotheiwise heck cn aaswet ~a you ss, Zr smofc~t-I~avo b1~ak if avt ap. ' -- ,. - - O Almost none U About 25% O About 50% - O About 7596 0 Almost 100% f 4.4 How much do the people closat to you want you to atop smolcint?=Check one answer. O Not at all - O Not much O Neutrsl O Somewhat O Very much =. ~ I; you wer: to stop srnokinY, how helpful would the people closest to you be? 0 Not helpful 0 Not much help O tieutral J Sontwhat helpful O Very helpiul S. Assessin; Your Desire to Stop Smoking. >ou senousiy planning to stop smoking? 7J Yes. have already stopped ~ OYes, in,the next 30 days O Yes, in the next 6 months 0 Yes, in the next year 0 Undecided rJ Not p,anning to stop 5.2 How motivated are you to stop smoking completely.7 (Check one answer.) O Not at all mulivated 0 Not too motivated O Neutral O Somewhat motivated O Very motivated 5.4 How long have you wanted to stop smoking? O Never wanted to 0 For a week or less O A week to a year O For over a year 5.5 If you have stopped staoldr:g cigarettes completely, wheD did you stop? 5.6 Are you ready to set a stop date? - O No O Yes, Stop date = s 0 m v m m v
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. : ^rrzn oix s ,- . 6. For Hospitallted Patients -Onty 6.1 Date of hospital adrnission • b 6.2 Reason for hospiFali=ation _ I : . 6.3 How many days will you be it3 tbe hospital? days 6.4 Is/was surgery a part of this hospitalizatioa? 0 No OYes . 6.5 Were you aware of Mayo's Smoke-Free Policy before coming to tiiayo? DNo OYes 6.6 Did you cut back or stop smoking befbre/because of tbis hospitalization? C7 No O Yes . " 6.7 How many hours has it been since your last cigarette? hours 6.8 How difficult do you think it will be to refrain from smoking during this hospi:a::za- :ion? 0 Very easy 0 Easy O Neutral 0 Difficult C3 Very Difficult 7. For Medicare Pat3ents Only Medicare Patient's Acknowledgement of Noncovered Services The coverage provided to you by Medicare is timfted to medieal/surggcal services. Medi- care does not cover setvices like the Nicotine Depsadem Consalt3ag Ser»ce. Should you decide to receive this service, you will personally be responsible for payment. Your sigaa- ture is required below to authotite us to bill you for this service. Patienc SisuYtuie Patient Mediare s Prorider Signature Bitling/Pager * . . Osta 0 i )
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certification issues or a motion to dismiss, please state the full name and address of said witnesses. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Reynolds has provided affidavits for the following witnesses in opposition to plaintiffs' motion for class certification: Michael E. Parrish, Ph.D. Harold I. Schwartz, M.D. David E. Townsend, Ph.D. David Daniel N. W. Iauco Donahue, Esq. Addresses for Drs. Parrish and Schwartz are contained in their CVs, which have already been provided to plaintiffs. Messrs. Townsend, Iauco and Donahue are all employees of R.J. Reynolds Tobacco Company, 401 N. Main Street, Winston-Salem, NC 27102. INTERROGATORY NO. 2: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorney expect to call at any hearing relating to class certification issues or a motion to dismiss, please state the educational background of said witnesses. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Reynolds further states that the educational background of each individual identified in response to Interrogatory No. 1 is set forth in the affidavits and/or CVs that have already been provided to plaintiffs. INTERROGATORY NO. 3: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state the employment experience of said witnesses. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Reynolds further states that the CwmI Doc: 2M90 i 7
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- Any Quations mnccM'~ ~~:.: : ~~~fW r~ On ia f4is quardonaaire_ sho~ld coimxlcr . = :, - 4.u..i.~J.B~~ent= __ sosrcr copyriahc 1992 Mayo Fonoidzri _ mRb~ba .... _ . ,:J. . . .. . - -•- - - ~ "'ieh peimhdon, . 0 +s I 0
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employment background of each individual identified in response to Interrogatory No. 1 is set forth in the affidavits and/or CVs that have already been provided to plaintiffs. INTERROGATORY NO. 4: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state the subject matter upon which said witnesses is expected to testify. RESPONSE: Reynolds has not deterAined what witnesses, if.any, it may call at any such hearing. Reynolds further states that the •subject matter of the testimony of those individuals identified in response to Interrogatory No. 1 is se%t forth in the affidavits that have already been provided to plaintiffs. INTERROGATORY NO. 5: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state*the substance of the facts and opinions to which said witnesses is expected to testify. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Reynolds further states that the facts and opinions to which those individuals identified in response to Interrogatory No. 1 would testify, if called, are set forth in the affidavits that have already been provided to plaintiffs. - INTERROGATORY NO. 6: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state a summary of the ground for each opinion to which said witnesses is expected to testify. CwT01 Doc: 2392901 8 '
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"nicotine dependency" and defines "nicotine dependency" as smoking 16 cigarettes per day and smoking the day's first cigarette within 30 minutes after awakening. Reynolds objects to plaintiffs' definition of "addictive" on the grounds that it is overbroad in purporting to include any "pharmacologically active substance" and vague and ambiguous in its use of the term "physiological based dependence." Reynolds objects to Definition No. 4 on the grounds that it is factually erroneous. The American Psychiatric Association's Diagnostic and Statistical Manual (4th ed.) ("DSM- IV") does not define or even use the term "addiction." Similarly, Dr. Schwartz's affidavit does not define the term "addiction," but instead refers to "addiction" only in the context of plaintiffs' use of that term. F. Privileged and Otherwise Protected Information Plaintiffs' interrogatories do not, by their terms, exclude privileged or otherwise protected communications from the information sought and/or the documents to be produced. Reynolds, therefore, objects to each interrogatory to the extent that it seeks the disclosure of any information that is privileged or protected for any reason, including information protected by the attorney-client privilege, the work product doctrine, the joint defense or joint interest privilege, and/or any other applicable privilege or protection. Each response set forth herein is made subject to this objection. Further, Reynolds objects to these interrogatories to the extent that they purport to seek the production of documents CLUTOI Doc: 239Mt 5
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malpractice case; and (c) as a fact witness in his administrative capacity in a Connecticut action brought against Hartford Hospital. Dr. Parrish has never testified in any tobacco litigation and has never testified on the subject matter covered in his affidavit. Dr. Townsend testified regarding cigarette design (a) on January 14 and 15, 1993 at the 'trial in Kue2er v. R.J. Reynolds Tobacco Co., 91-L-734 (St. Clair Cty. Cir. Ct. Ill.); aw .(b) on August 15, 1996 at the trial in Rogers v. R.J. Reynolds Tobacco Co., 49D02-9301FCT-0008 (Sup. CA Marion Cty._Ind.); (c) at a deposition on October 3, 1995 in Connor v. R.J. Reynolds Tobacco Co., No. 95-01820-CA (4th Jud. Cir. Duval Cty. Fla.); (d) at a deposition on March 31, 1994 in Allgood v. R.J. Reynolds Tobacco Co., No. 91-00326 (S.D. Tex.); and (e) at a deposition on February 6, 1996 in Burton v. R.J. Reynolds Tobacco Co., No. 94- 2202 (D. Kan.). Mr. Iauco testified regarding cigarette advertising and marketing issues (a) on December 21 and 22, 1992 at the trial in jSyeper v. R.J. Reynolds Tobacco Co., 91-L-734 (St. Clair Cty. Cir. Ct. Ill.); (b) at a deposition on October 17, 1991 in Kueper; (c) at a deposition on October 2, 1995 in Connor v. R.J. Reynolds Tobacco Co., No. 95-01820-CA (4th Jud. Cir. Duval Cty. Fla.); (d) at a deposition on March 30, 1994 in $llgood v. R.J. Reynolds Tobacco Co., No. 91-00326 (S.D. Tex.); and (e) at a deposition on March 28, 1995 in Mangin; v. R.J. Reynolds Tobacco Comeanv, No. 939359 (Super. Ct. Cal.). CLtaTOt Doc: 2392901 10
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' 13 ~ MEMORANDUM TO: Michael Nims FROM: Harold I. Schwartz, M.D. DATE: September 17, 1995 SUBJECT: The Relationship of Physiological and Psychological Factors: Withdrawal S-,mptoms Ockene Jh, Nutall R, Benfari RC, Hurwitz I, and Ockene IS. A psychosocial model of smoking cessation and maintenance of cessation. Preventive Medicine, Vol. 10, pp 623-638. 1981. "Pharmacological and physiological factors play a role in smoking behavior change. However, they fail to explain the great variability observed in individual responses. In one investigation, nicotine regulation was found to apply to heavy smokers but not to light smokers (76). Although there is a greater likelihood that lighter smokers will be more successful at cessation, there are light smokers who cannot stop just as there are heavy smokers who quit easily. Most of the effects of nicotine are short-term, and therefore it is difficult to understand how they can explain relapse after a somewhat extended period of cessation (51, 72, 73). ... Physiological and psychological depen- dencies are interwoven (75), and both need to be considered if we are to help the 25 million smokers in the United States who would like to permanently stop smoking but have been unable to do so (27)." Hatsukami DK, Hughes JR, and Pickens RW. Blood nicotine, smoke exposure and tobacco with- drawal symptoms. Addictive Behaviors, Vol. 10, pp 413-417, 1985. "The relationship between the nicotine intake and severity of tobacco withdrawal symptoms, however, remains unclear (Shiffman, 1979). Some studies have found no differences in withdrawal symptoms between light and heavy smokers (Myrsten, Elgerot and Edgren, 1977; Mausner, 1970; Gritts and Jarvik, 1973). Other studies have found a positive relationship between withdrawal symptoms and daily cigarette consumption (Burns, 1969; Wynder, Kaufman and Lesser, 1967)." "The present study examines the relationship between both subjective and objective measures of tobacco withdrawal symptoms and blood nicotine levels as well as blood cotinine levels, half-life for nicotine and total smoke exposure/day ... whether tobacco withdrawal symptoms result from nicotine deprivation or other factors such as removal of a reinforcers, or disruption of a habitual behavior is unclear (Hatsukimi, Hughes and Pickens, in press). If tobacco withdrawal symptoms are related to serum nico- tine/cotinine levels, this result would suggest that tobacco withdrawal symptoms are due to nicotine deprivation and that the treatment of withdrawal symptoms by nicotine replacement would be useful in the treatment of smoking behavior."
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or information from the files of in-house counsel who were or are actively engaged in the defense of smoking and health litigation, or to prepare a privilege log that would provide a road map to Reynolds' trial preparation activities. Accordingly, consistent with past practice, Reynolds does not interpret these interrogatories as seeking the production of such documents (or the preparation of privilege logs with respect thereto). Further, Reynolds does not interpret these interrogatories as seeking litigation materials sent to Reynolds by its outside counsel. G. Trade Secrets.and Other Confidhntia1, _ p~Qprietary Business Information. Reynolds objects to plaintiffs' interrogatories to the extent that they seek trade secrets or other confidential or proprietary research, development or commercial information and/or documents without any showing of need -- much less compelling need -- for such information. Any offer to provide information containing confidential or trade secret informatipn in this action is and will be conditioned upon the entry of a: suitable protective order. II. RESPONSES TO SPECIFIC INTERROGATORIES Subject to and without waiving any of its recurring objections, which are incorporated by reference into its responses to the individual interrogatories as appropriate, Reynolds responds to plaintiffs' interrogatories as follows: INTERROGATORY NO. 1: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorney expect to call at any hearing relating to class cLLlT01 Doe: 2392901 6
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Unforeseeable Liability for Patients'. Violent Acts Stephen Rachlin, M.D. Harold I. Schwartz, M.D. Psychiatrists have been held lia- ble for violent acts committed by tbeir patients when more than an error in professional judgment could be demonstrated. The au- thors describe several recent court cases in which judges have ig- nored or distorted acceptable clinical practices, conceivably creating a new liability standard whereby a tragic outcome is con- sidered the result of failure to apply appropriate judgment. Fol- lowing discussion of the cases are recommendations for managing the risks attendant to psychiatric decision making today, such as gathering as much of the patient's history as possible, obtaining previous records, documenting clinical reasoning, and consult- ing colleagues. Reforms for the legal process are also suggested. The Tarafoff case (1) is probably better known among mental health Dr. Rachlin is chairman of the department of psychiatry and psychology at the Nassau Coun- ty Medical Center, 2201 Hemp- stead Turnpike, East Meadow, New York 11554, and associate Professor of clinical psychiatry at the State University of New York at Stony Brook School of Medicine. Dr. Schwartz is physi- cian-in-charge of the program in psychiatry and law at the Beth Israel Medical Center in New York and assistant profes- sor of clinical psychiatry at Mount Sinai School of Medi- cine. professionals than any other in the annals of psychiatry and the law. It has stimulated dozens of articles and chapters in the medical litera- ture, many of which are polemical. An entire book (2) has been devot- ed to the repercussions that fol- lowed the California Supreme .Court's pronouncement that when a therapist knows, or in accordance with the standards of his profes- sion reasonably should have known, that a patient presents a serious risk of harm to another, the therapist incurs an obligation to use reasonable care to protect that third party. Though Taraloff is the bellweth- er regarding the expansion of li- abiliry for patients' violent acts, subsequent cases, as summarized by Beck (3), may signal that the trend is accelerating. The criteria by which culpability will be deter- mined lies at the heart of the issue. Mills (4) has opposed application of an ordinary negligence standard because of the immature technolo- gy used in the prediction of dan- gerousness. Appelbaum (5) has cited significant cases that ap- proach strict liability, the legal the- ory in which liability is found whenever damages occur, regard- less of whether negligence can be proven. It has even been proposed that psychotherapy itself is so in- herently dangerous a practice that strict liability ought to be applied in any bad result (6), an approach critiqued elsewhere (7). Psychiatrists have long been held liable for the injuries caused by their patients when the violent acts were proximally relaced to a negligent release from a hospital or other similar situation. The legal criteria for such findings are well EXHIBIT established in tort law. They re- quire that the physician provide due care, use ordinary medical skill, and exercise professional judgment. If he or she failed to do so and as a result of this failure a patient injured someone or killed himself or a third party, liability could be found. However, an error in professional judgment, "without more," was insufficient to demon- strate malpractice. Courts recog- nized that risks to public safety must occasionally be taken in the interest of patient care. Only in cases in which a physician did not use his judgment could he be made to answer in damages. We describe a series of New York cases, recently discussed by Petrila (8), that were d4cided on the basis of these fundamental neg- ligence principles but that com- pletely distorted or ignored ac- ceptable clinical practices. In doing so the courts have conceivably cre- ated a new standard of liability that considers a bad outcome with a patient chronically at risk for vio- lent acts to flow from a clinician's failure to apply professional judg- ment. Following presentation and discussion of the cases, we will recommend techniques for manag- ing the risks attendant to psychiat- ric decision making today. Case examples Case 1. The patient received a medical discharge from the mili- tary in 1971 and had been hospital- ized at least once in a Veterans Administration hospital because of suicide risk (9). Five years after his medical discharge, when he was 27, he was admitted to a municipal hospital and diagnosed as suffering from paranoid schizophrenia. On Hospital and Community Psychiatry July 1986 Vol. 37 No. 7 725
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\!k OTi\? !': ^1 \;'*! \, : Consequer;e~ ot in% oiuntarv Nmui;mc: A Rerort ot tnr -turt:coc i?. \'ri,ccr Vi'E. F.1\., 1... \- Grnera:. \\ a;ntn_ron. DC. L'S Golernmenr I'nnnnt: (lfntc. Plrr:e II': hl.tnrun„r, ,•. .n,. , __. . w , .. .. .. . I'+Kh IF; I - z. .rntansr .amrit.. l'rc•% \Ic.: k- 23. Orn.r or Health and Envtronmental .\sseisment: Resrlnron 4:. Hal! R(,.1)unamr! M. \Ia iananr• K. \I:,:•... \.,..` ., i.• Health Etrectc or Passll rSmokmc: Lun, Cancrr anJ Other Dr- .rn N. whllirr 1'. Ta„-) „nc•na_.; i . H.ti. .\!: i c;; , .... ,. . oniers. \C ashlncton. DC. l's Government Prtnrtn_ Utn:c. I au_ In~. •rlcrln tit llmr••. an,! .n1.a,1nZ •:atU• .1nL,::: IFi 24. Huches 1R: Rlsk/benernt oi nicotine replacement in smoktnc:ri- sauon. Druc Sat 1993; 5:44-56 IFJ 25. Benoxvttz NL: Toxtctrn of nicotine: tmpLcanuns with regard to nicotine replacement tnerap}~. in Nicotine Replacement: A Crttl- cal Ecaluauon. Edtted b~ Pomerlcau OF. Pomerleau CS. Faeer- strom F:O. Hennm_cneld IE. H uches JR. New York. Alan R Llss. 19SS. pp lS ''-I IFI 26. Glassman AH. Cocel L5. Dalack GW. Stemer F. Rn•elli 51:. Fleiss J. Cooper TB: Smoking cessation. clonidine. and vulner- abihrc to nicotine among dependent smokers. Citn Pharmacol Ther 1993; 54:6'0-6'9 IA] 27. US Department of Health and Human Services: National trends in smoking cessadon, in The Health Bene6ts of Smoking Ces- sation: A Report ot the Surgeon General. Washington. DC, US Government Printing Office, 1990, pp 580416 (FJ 28. Hughes JR: Generics of smoking: a brief review. Behavior Ther- ap}• 1986: 1':335-34? ]FI 29. Heath AC. Madden PAF: Genertc influences on smoking behah- ior, in Behavior Generic Approaches in Behavioral Medicine: Perspectives on Individual Ditterences. Edited hl• Turner JR. Cardon LR. Hew•itt Jl:.New• York. Plenum. 1995, pp4:-66IF] 30. Swan GE. Carmelli D. Rosenman RH. FabsriF RR. Christian JC: Smoking and alcohol consumption in adult male rH•ins: Fe- neric heritabilit.• and shared environmental influences. J Subst Abuse 1990: 2:39-50 I B] 31. Breslau N. F:ilhel• MM. r\ndreski P: DSSI-l11-R nicotine de- pendence in vounc adults: pre.•alence, correlates and associated psychiatric disorders. Addiction 1994; x9:"4±-':4 IGJ 32. Hale KL, Hughes JR. Olivero AH. Helzer JE, Higgins ST. Bickel WK, Cottler LB: Nicotine dependence in a population-based sample, in Problems of Drug Dependence. 1992: NIDA.Re- search Monograph 132. Edited by Harris IS. Rockville. Md. National Institute on Drug Abuse, 1993, pp 181 (G) 33. Ziedonis D\1. Kosten TR. Glazer u'\t. Frances R.1: Nicotine dependence and schizophrenia. Hosp Comm Pccchlam- 1444; 45:204---106 I F I 34. Hughes JR: Clinical implications ot the association between smoking and alcoholism, in Alcohol and Tobacco: From Basic Science to Policy: NIAAA Research Monograph 30. Edited Ill Fertig J. Fuller R. Washington. DC. L'S Government Printing Office. 1995, pp 171-181 IFI 35. Klesges RC, Meyers AW. LaYasque \lE: Smoktng, body weight and their effects on smoking behavior: a comprehrnsn•e review of the literature. Ps.•chol Bull 19890 106:211-1-?3() (FI 36. US Department of Health and Human Services: Tobacco use compared to other drug dependencies. in The Health Conse- quences of Smoking: Nicotine Addiction: A Report of the US Surgeon General. Washington, DC. US Government Printing Office. 1988, pp 241-376 IFJ 37. Henningfield JE. Clayton R. Pollin W: Involvement of tobacco in alcoholism and illicit drug use. Br J Addict 1990: 85:279-292 IGI 38. American Psychiatric Association: Practice guideline for the treatment ot patients with substance use disorders: alcuhul, co- caine, opioids. Am J Psychiatry 1995: 152(Nov supp1):1-59 IGI 39. Prochaska JO, Goldstein MG: Process of smoking cessation: implications for clinicians. Clin Chest Med 1991; 12:727-735 IF) 40. Hughes JR: Applying harm reduction to smoking. Tobacco Control 1995; 4:S33-S38 I F) 41. Hughes,IR: Long-term use of nicotine-replacement therapy, in New Developments in Nicotine-Deliven• Systems. Edited by Henningfield JE, Stitzer ML. New York. Carlron, 1991, 64-71 (F] 42. Benowitz NL: Pharmacologic aspects of cigarette smoking and nicotine addiction. N Engl J Med 1988; 319:1318-1330 (FJ ;htat•n, rattrnt.. I\cn \1c•nt 111. !-:; -l5. lirr•ut: N. I:Ilrrt MNI. AnJrc,AI 1': \I;nnnc ~r^cnaet:,; .c:, m.nur .irrrr••wr: nc•1% r%t.ic•n:c tn'tr. a rrn.rrallc n,m. Arch (,cn I'a:nratn 1-u?: clI:tl-;: is -tb. Bresiju N: N\'chlatrt: aomorM,tln N: ~InVwln~.l::,: nl,,.an; ,.. rendentc. Rrha% (trnrt I111;:_4:"i-ItI I ;t,' 4-. Vi oKxic GE. C<.rrlrr Ll+. (.a;a„i.t l: •c•%c•nn „t from thr DS\1-1\' nr1J tnai.. AJJ::u,a: Z-;-I ~-~ IGI 48. Pomerleau CS, Matehrzak \11. Pomerleau (1t-: \Icr,tlnr dr- pendence and the Faeerstrom Tolerance Questionnaire: a Fnr- revtew. J Subst Abuse 1989: 1:4'1-1-' IF) 49. Orleans (T: Treanng m:,,nnr dependence tit mc•Jl;ai .rrrme•: a stepped-care moJrl, in Nicotine Addiction: 1'nn:trir, an,: Management. Edited h.• Oric•,tn. CT. SIaJr 11). \c.. ) nrl. t h- tord Uml•erstrv Pres.. 1`+y3, pr la>-Ir,I I61i ill, (lr!eansC-T,GI1-nnTl..\lanlrl \t\C-.,%I.1Jc Il): \Imunai-:onta:: ; qult smukmg stratrclra tlir mcJ/:ai .rntn_.. Ii+IJI pp 1S 1-211111 i1. US Department tit Health anJ Human 1trr.l:r.: Trratmrnt „t tobacco JepenJencr. in The Hralth (.un.r.lurn;r, tit %mlwktn,: Xt.uttnrAJJl.tlun. \\'ashtngtun, I)(., l;% lN,lrrnmrnt 1'nnnnp Office. 1Nxx, rp 4Sy-:Ml IFI i 2. Benaw•Irz NL: The u.r of hinll>LI; tltod .amplc•• in asxasrtr~ tu- ha.:r, smukr cunsumptiun. \ II) a Rc. \ tunt>Lr 148.3 :4.1;:e-_a I F I 53. Hu~hr. JR: Treatment tit nicotine dependence: t% more hrnrr: Ia\LA IV4i;?-a:l.i'1(t-I..ul IFI 54. Lerman C. Orlran. (T, Fnc.trum I'F: BwhKt.al markrr% in smllktnl;.e.ssation tr.atmrnt. k•mnt l)ncolt>gv lyy3:21):,iiy- :6-IFI 33. \'rh:rr \C'F, Pro`haska 1O, Ru..l IS. Snow \IG: assrssin} nut- .ome in smaktn}.essatlon stuJtc%. Psvchol Bull 1992: 1 1 L•2?- 41 IFI 56. Law M. Tanl; JL: An analvas of the rttrcnl•rncsc of tntcn•rn- ttons intended tit help people su,p .nluktng. Arch Intern Med 1`+y:: 1~.;:19.;:-1y4 11 kl 5-. Bailhc :1. \latn:k RI', Hall \\ ,\\ c•h.trr 1': \Irr.ranaka: rcl-Irll af the etn.acl• ot smoking .rscanun interventions. Drug anJ Alcohol Rev lyya: 13:1 .i'-1-U IF:I 5S. Korike TE. Harncta RN. I)rFnr.c• GH. Krekkc ML: attrihutec „f succesctul smoking crc.anlm mtrrventtnnc in medical rrar- ncr: a meta-analc.,c of 3y.rmtndlc•d trnals. JAS1A Iyxx;.5`1: 2xx2-2xSylEl Fiore MC: Cigarette smuking. \IcJ (:hn North Am 1992: 76: 2xy-;;_ It•t 60. Abrams I)R: Treatment iscurs: tu.l•arJ% a stepped-care model. Tobacco Control lvy3; 2:tiI--S3- IFI 61. Gl.•nn TJ, \lanlev \1W: How To Help Your Paacnt. Stop Smoking. VC ashin};tnn, DC. L/S (:ol•crnntent Printing Ofticc, 1984 I(il 62. Sa.h. DPL::WI•ancrs in smoking ccssarion treatment. Current 1'u1momodnL}• lyyl: 12:I3y-Iyx IFI 63. GulJstrln \IG, Nlaura R. Ahram. 1)B: Pharmacological and behavioral treatment of nicotinr dependence: nicotine as a drug tit ahu.c, in XIcdical 1'cychlatn: Practice. vol I. Editrd by StuuJrmirr A. Fogel RS. Wa.hin};tun, IX:, American Psychiatric Press. 1 yy 1. pp 3 41-5 96 1 F 1 64. Sachs DPL. Lrischoss• ti/: Pharmacollgical approaches to smok- ing cecssauon. Clin Chest \Ied 1991; 12:9-10 JFI 65. Hughes JR: Behavioral support programs for smoking cessa- tion. Modern Medicine 1y94:62:22-26IF) 66. Orleans CT, Sladr Jf) leda: Nicotine Addiction: Principles and Management. Ncw York. OxfnrJ Univcrsit)• Press,.1993 IFJ 67. Startick RP. Baillie A. An Outline for Approaches to Smoking Cessatirin: Quality Assurance Project. Canherra, Australian Government Publishing Scrvice. 1992 IFI • 68. Hughes JR. Francis RJ: How to help psychiatric patients stop smoking. Ps9chiatr Serv 1995; 46:435-445 IG) Am J Psychiatry 153:10, October 1996 Supplement 51770 6 918 27
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Mr. Donahue testified on a variety of issues on January 11 and 12, 1993 at the trial in Kueeer v. R.J. Reynolds Tobacco Co., 91-L-734 (St. Clair Cty. Cir. Ct. Ill.), but has never testified regarding the subject matter of his affidavit in this case. INTERROGATORY NO. 8: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state whether said witnesses is or was licensed to practice medicine. If so, state: (a) the area of medicine in which said witnesses is licensed; (b) by whom said witnesses has been licensed; (c) when said witnesses became licensed; (d) whether said witnesses's license has ever been revoked, suspended, or challenged. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that, to the extent it seeks such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Subject to and without waiving its objections, Reynolds states that the requested information regarding Dr. Schwartz's medical license is set forth in his CV, which has already been provided to plaintiffs. Dr. Schwartz's medical license has never been revoked, suspended or challenged. INTERROGATORY NO. 9: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing C[.uTOI Doc: 23929o i 11
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plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state whether said witnesses is or was Board Certified in any area of medicine. If so, state: (a) the area of medicine in which said witnesses is Board Certified; (b) by whom said witnesses has been Board Certified; (c) when said witnesses became Board Certified; (d) whether said witnesses!s Board Certification has ever been revoked, suspended; or challenged. RESPONSE: Reynolds has not determined what witnesses, if any, it 2W may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on ttbe ground that•, tb the extent it seeks such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Subject to and without waiving its objections, Reynolds states,that the requested information regarding Dr. Schwartz's board certification in psychiatry is set forth in his CV, which has already been provided to plaintiffs. Dr. Schwartz's board certification has never been revoked, suspended or challenged. INTERROGATORY NO. 10: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe any education or training said witnesses received relating in any way to nicotine addiction (however defined). RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that, to the extent it seeks CLUTOI Doc: 239290 1 12
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RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Reynolds further states that the grounds for the opinions to which those individuals identified in response to.Interrogatory No. 1 would testify, if called, are set forth in the affidavits that have already been provided to plaintiffs. INTERROGATORY NO. 7: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please list all sworn testimony said witnesses has ever given, and describe the substance of all sworn testimony. If the sworn testimony was given in a lawsuit, please provide: (a) the Court in which the case was docketed; (b) the docket number of the case; (c) the date(s) of said witnesses's testimony; and (d) the subject matter of said witnesses's testimony. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that it is overbroad to the extent that it purports to require information regarding prior testimony that is irrelevant to this litigation. Subject to and without waiving its objections, Reynolds states that Dr. Schwartz has never testified in any tobacco litigation and has never testified on the issue of nicotine "addiction" or "dependency." In the last four years, Dr. Schwartz has testified (a) in a New York action regarding psychological injuries suffered by an assault victim; (b) in a Connecticut-action regarding psychological injuries suffered by a plaintiff in a medical CLLITOI Doc: 2392901 9
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such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the discovery of admi.ssible evidence. Reynolds further objects to this interrogatory on the ground that the term "nicotine addiction" is vague and ambiguous and improperly and inadequately defined in plaintiffs' instructions. Reynolds also objects to this interrogatory on the ground that it is cumulative, oppressive and harassing, given that plaintiffs intend to depose Dr. Schwartz and may put this question to him directly. Subject to and without waiving its objections, Reynolds states that in addition to his general psychiatric and medical training, Dr. Schwartz received training in substance abuse principles during his residency and received training in hypnosis, including the use of hypnosis in smoking cessation. Dr. Schwartz has also attended American Psychiatric Association continuing medical education programs on cigarette smoking. Dr. Schwartz has had substantial experience in (a) the assessment of individuals with substance abuse problems during his tenure at the Institute of Living, Beth Israel Medical Center, the New York Hospital-Cornell Medical Center and NYU- Bellevue Hospital Center and (b) administrative/supervisory responsibility for substance abuse programs at the Institute of Living. Dr. Schwartz has counseled patients regarding smoking cessation and has assisted them in quitting smoking while treating them for other conditions. With a few patients, he has used hypnosis in order to help them quit smoking. CLLrrol Doe: zM9o_i 13
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plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state whether said witnesses has ever provided Treatment to a person for being Nicotine Addicted (however defined). If so, state (a) the.number of persons'said witnesses has treated for Nicotine Addiction; (b) the period of time over which said witnesses treated them; (c) the method(s) of treatment used. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 19: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state the criteria -- if any -- that each expert currently uses to assess whether someone is Nicotine Addicted (however defined). RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that, to the extent it seeks such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Reynolds objects to this interrogatory on the ground that the term "nicotine addiction" is vague and ambiguous and improperly and inadequately defined in plaintiffs' instructions. Subject to and without waiving its objections, Reynolds states that Dr. Schwartz does not assess and has not assessed whether someone is "Nicotine Addicted." Indeed, Dr. Schwartz cwTO1 Doe: x34290_t 17
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(c) if it was published, the source in which it was published; (d) if it was published, the date it was published; (e) its subject matter; and. (f) whether it was peer-reviewed. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 17: Regarding &11 witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom'you or your attorneys expect to call at any hearing relatiTig 'to class certification issues'or a motion to dismiss, please state whether said witnesses has ever personally Diagr ~osed si person as being Nicotine Addicted (howe}cer defined). •If~so, state the number of persons said witnesses has'diagnosed as being Nicotine Addicted. RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that, to the extent it seeks such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the . discovery of admissible evidence. Reynolds further objects to this interrogatory on the ground that the term "nicotine addiction" is vague and ambiguous and improperly and inadequately defined in plaintiffs' instructions. Subject to and without waiving its objections, Reynolds states that Dr. Schwartz has, for a small number of patients, entered the DSM-IV code for "nicotine dependency" where records required such a diagnostic code. INTERROGATORY NO. 18: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing cwToi Doc: 2392901 16
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Apart from his normal reading of the literature on substance dependence and his reading of the materials on "nicotine dependency" and "addiction" cited in his affidavit, Dr. Schwartz has not-done any research on "nicotine addiction." Dr. Schwartz has been a professor of psychiatry at the Mount Sinai, NYU, Cornell, and Connecticut medical schools, but has not taught a course regarding nicotine "addiction." Dr. Schwartz has not published any writings, made any (lresentations, or received any awards regarding-nicotine "addiction."" or INTERROGATORY NO. 11: Regarding all witnesse`s who have given affidavitsn in support qt your motion t0rlismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe all things said witnesses has done in the course of his professional employment relating in any way to nicotine addiction (however defined). RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 12: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe any teaching said witnesses has done relating in any way to nicotine addiction (however defined). RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 13: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe any awards or honors said witnesses has received relating in any way to nicotine addiction (however defined). CwTOI Doe: 239290 1 14 '
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I :.: I admission he gave a history of drug abuse and was hallucinating. The physician noted that the patient showed no evidenc_e of suicidal risk. Six days after admission, the pa- tient had to be restrained during an attempt to medicate him. The next day the treating psychiatrist con- sidered the patient to be stable and not dangerous, and he discharged him with a prescription for an anti- psychotic drug. One week later the patient attempted suicide by self- immolation, apparently in re- sponse to newly developed halluci- nations. The court found that the suicide attempt resulted from "something more" than a mere error in profes- sional judgment and that since the decision to discharge was not the product of a careful examination, it was not a professional medical judgment. In candor, it must be noted that the defense was consid- erably weakened by the doctor s own admission that some aspects of the patient's care were not fully in accord with good medical prac- tice. The connection between this departure from good practice and subsequent events was described by the court as a substantial con- tributing factor to its decision. The clinician was faulted, for example, for failing to inquire into the na ture of the patient's delusions. Despite the departures from good medical care in this case, the logic of the judicial conclusion that suicide is foreseeable for a delu- sional patient who lacks self-de- structive ideation eludes us. The plaintiiTs expert witness claimed that it is unsound to discharge a psychotic patient on his own and to give a prescription to a noncom- pliant individual. Case 2. A 44-year-old man with a 12-year history of psychiatric ill- ness was found naked and mutter- ing while cutting vegetables he had retrieved from the garbage in his sister's apartment (10). He had left a day treatment program a year earlier, and his condition had dete- riorated over the three months pri- or to the index hospitalization. On admission the patient sat 774 motionless. He described paranoid and grandiose delusions and de- nied suicidal ideation. His sister allegedly told the staff on duty that he had once jumped out a window, but the information was not in- cluded in the medical record. The patient remained calm after admis- sion and was observed to be sleep- ing. Several hours later, without warning, he jumped out a fifth- floor window (literally slipping from the grasp of an aide who attempted to restrain him) and sus- tained serious injuries. The claimant's expert witness stated that such a patient should have been placed in a room with detention screens on the window and kept on one-to-one supervi- sion, that a diagnosis should not have been made without previous medical records, and that one could not rely on a schizophrenic patient's denial of suicidal thoughts or impulses. The court found for the plaintiff on the basis of negligent lack of supervision inconsistent with knowledge about the patient. The opinion emphasizes the patient's past suicidal propensities. A note in the medical record that the pa- tient was admitted to prevent inju- ry to self or others was credited by the court as being very meaningful, while to us it appears as no more than a boilerplate phrase to indi- cate compliance with legal require- ments for involuntary admission. The court claimed that in making a finding of negligent lack of super- vision, it did not have to address the question of whether an in- formed medical judgment had been made. We feel otherwise. The decision to put a patient on one-to-one ob- servation at the time of admission is a professional judgment. The patlent's behavior and suicidal ide- ation were assessed upon admis- sion and the results recorded. The court could not have reached its conclusion without dismissing the physician's judgment that stricter supervision was unwarranted. Case 3. This patient's first re- corded psychiatric contact was in 1971, when he was hospitalized at age 21 following a suicide attempt (11). Upon admission he was hallu- cinating and was diagnosed as a paranoid schizophrenic. In an al- tercation with the police in 1974, he broke a trooper's leg, an offense for which he was found not guilty by reason of insanity. This incident was followed by a nine-month hos- pitalization, discharge, and several brief inpatient admissions. After a discharge in January 1977, he was created as an outpatient with anti- psychotic medication. More than a year later, the pa- tient's friends contacted the outpa- tient staff to express their concern over what they saw as a deteriora- tion in his mental status. The treat- ing psychiatrist saw the patient on February 21, March 1, and March 7, 1978. Although psychotic, the patient was deemed not to need hospitalization but rather weekly clinic visits. His condition was de- scribed as marginal. The patient missed his appointment on March 15, and the friends reexpressed their concern to staff on the 11th. On March 22 he missed another appointment, and on March 23, for obscure reasons, he committed a serious assault. In an unusual step, the appellate court overruled the dismissal of the claim and directed a judgment for the plaintiff. The three-judge majority concluded that the deci- sion not to hospitalize the patient on March 1(note that the psychia- trist saw the patient again after this date) was not an intelligent, profes- sional medical judgment because it was not founded on a careful eval- uation of the patient and all other available information. The "some- thing more" than an error of judg- ment emphasized in the court's opinion was the contact from the patient's friends, coupled with the patient's serious diagnosis, use of street drugs, lack of cooperation with medical treatment, and his- tory of suicide attempts. Continu- ing weekly outpatient care repre- sented, -to the court, an "almost casual consideration" of the pa- tient's and the public's needs. The two'dissenting jurists dem- onstrated a sound grasp of clinical L ,
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: t. ArtEN O IX B A fotmal ctasation prt~r.im (for exa:apk; :with clazses,. gronP discvasioas, etc.) . --- - _. _' - - - . A privatc consultation vritb your doctor or mental hcalth'professional Hypnosis _ -- Nicoiine medicated gum . _ ~ Other, vicase desrn'be 3.8 Have you used nicotine skiii patches? DNo OYes , - l How many times? _ Any probiems with the patch? ~ 3.9 When was your last attempt to stop smoking? - rJ never attempted hours days weeks months .'ea 's's ago 3.10 For now ',ong did you go without smok:::b at that tiia:? ` never attemrteC T_ ;.ours days w•eeks :r,ontas How did you stop? ,., r Descri bc Why did you s-art again? 3.11 If you are still smoking, what has kcpt you from stopNing? 4. We Wvuld Also Like to Know How Much Support You Have for Your Efforts to Stop Smoking. 4.1 Please indicate tlrose rtlativcs who reButarly smoke.-Check a11 that apply. O Spouse/sigaifiant other O Parent(s) O Child(ren) 0 Grandparent(s) O Inlaw(s) O None of the above 4.2 Among your clost friends. what pcrcentage would 'you say smoke?-Check one.answzr. _ O Alasost none D About 2346 D About 3096 . _ . • O About 75% . " O Almost 100% , -j m m m
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APPENDIX B =- Mayo Foundation Nicotine Depende.nce..Center ~ :: --- -- -- : Patient Questionnaire - =- --:- -~ - MAYO NICOTIAIE DElEN>fNCE CENTER PATIENT QUESTIONNAIRE Instructions T Please complete the following qiiestionnaim by filling in the blanks and checking the appro- p;iate boxes. ?he questions evaluate various aspects related to your smoking. It takes 3sout 15 minutes and should be completed and available when the smoking cessation counselor sees •oU. * 1. General Information : r :. t Today's date: i 1.2 Your Mayo Clinic registration number. - - - _ - - _ - 1.3 `ame (please print): 0 Mr. 0 Mrs. O Miss O Ms. O Other mo. aay ysat FieA Mwdk M Phone: Home (---)--- -_- .r. Work (_ - ~---- ---- Best time and place to contact you by phone: OAM OHome Timc: E3 PM at O Work ~. 1.4 Gender. O Male O Female ~ 1.5 Date of birth: ma 1.10 Usual occupation/profession: 1.6 Height ft. in. Weight lbs. 1.7 Marital status: O Sinzie OManied Q Diyorced/SeParated O Widowed 1.8 Race: O White O Black O American~Indian O Oriental 0 Other 1.9 Mayo Medical Center Employed: . 0 No .[3 Yes ~ ~ PLANITI~fF't OEMSITION DINNiR ~~«
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states in his affidavit that the term "addiction" has been largely abandoned in favor of "dependency." INTERROGATORY NO. 20: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs"motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state all criteria -- if any -- that each expert formerly used to ascertain whether someone is Nicotine Addicted (however defined). RESPONSE: Reynolds incorporates.its objections and response to Interrogatory No. 19 as if fully set forth herein. ~ - INTERROGATORY NO. 21: Regarding all witnesses who have given affidavits in support of your motion to dismips or opposing plaintiffs' motion for Flass certificatibn or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe all statements (whether oral.or in writing) said witnesses has ever made relating in anyway to Nicotine Addiction (however defined), including but not limited to when, where, and to whom the statement was made. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 22: Regarding all witnesses who have given, affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please state whether or not each believes that nicotine is addictive: (a) as that term is defined herein; (b) as that term is used in the 1988 Surgeon General's Report; (c) as that term is used in DSM IV; (d) as that term is used in the affidavit of Harold I. Schwartz; and (e) under any other definition used by said witnesses, and set forth the basis for these beliefs. cwroI ooe: 2M9o i 18 ,
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2.20 Do you smoke when you are so ill that you are not able to carry on your normal activ- ities? ONo 0 Ycs 2.21 Do you usc tobacco deXpite a serious physical disorder which you know is made worse by tobacco u-se? O No 0 Yes-what is the serious physical disorder? 2.22 Do you ever find yousselfstnoldng more than you intended? O No D Yes, destribe 2.23 Has a doctor ever told you to-stop smoking? O No 0 Yes, why? 2.24 At this ,isit has a Mayo doctor told you to stop srnoldng? ,:~ No _ Yes 3. History of Stopping Smoking ' 3.1 Have you tried to cut down or lirait your smoking? o CY:s 3.2 Ho~ rr:any umes have you attempted to stop smoking? 3_ Ho :. mar..+ :;;n_s i,.ave you stopped sraokin; fer a: least or.e 4a•:? ;.a uncomfortable symptoms when you stopped scnokir.g' 'r' Docs not apply-I havc ncver stopped smoking. 1 have stopped smoking in the past but never experienced uncomfortable symp- toms! - O 1 have stopped snoking in the past and have experienced uncomfortable symp- toms. If yes 3.5 What symptoms did you experience when you stopped smoking?-Check all that you e.xpcrienccd. C] Craving D Anxiety CI Restlessness O Decreased heart rate 0 Increased eating O Difficulty concentrating O Irritability U Other 3.6 Since you started smokinE rcgularly, what is the longest time you have gone without smoking anything? (Check one answer.) O Never gone without smoking O Lcss thau s day O At least one day but less than one week O At least one week but less than one month O At least one month but less than one year O One year or more 3.7 Enter- the numbcr of timea you hare tried the following metbods to stop smoking. Self-help material (for exarnple American Lung Association material, ma- I terials fsom doctor, ctc.)
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RESPONSE: Reynolds has not determined what witnesses, if any, it may call at any such hearing. Furthermore, Reynolds objects to this interrogatory on the ground that, to the extent it seeks such information regarding any witness other than Dr. Schwartz, it is overbroad and seeks the discovery of information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. Reynolds objects to this interrogatory on the ground that the term "addictive" is vague and ambiguous and improperly and inadequately defined in both plaintiffs' instructions and this interrogatory. For example, the Surgeon General's 1988 Report does not contain a specific definition of the terms "addictive" or "addiction"; DSM-IV does not use the terms "addictive" or "addiction" at all; and Dr. Schwartz's affidavit refers to the term "addiction" only as used by plaintiffs. Moreover, Reynolds objects to this interrogatory on the ground that it is cumulative, oppressive and harassing because plaintiffs intend to depose Dr. Schwartz and may depose this question to him directly. Subject to and without waiving its objection, Reynolds states that Dr. Schwartz does not believe that "addiction" is an appropriate description of cigarette smoking or that nicotine can be described as "addictive" in any meaningful sense. INTERROGATORY NO. 23: Regarding defendants' expert witness, Dr. Harold I. Schwartz, please define "Nicotine Dependence" as it is used in his Affidavit. RESPONSE: As set forth in the affidavit that has been provided to plaintiffs, Dr. Schwartz primarily refers to the definition of "nicotine dependence" as used in DSM-IV and its predecessors. cLumt Doc: iM9o 1 19
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reality, but to no avail. They noted that for 15 months prior to the incident, the patient was in the community for all but three weeks, when he was voluntarily hospital- ized, and had assaulted no one during that time; furthermore, his principal danger had always been to himself. When the patient was seen by the psychiatrist on March 7, fol- lowing the first statement of con- cern by his friends, he was ob- served to be improved and "more in control," an assessment with which his friends concurred. There was no evidence that the friends' call to the clinic on March 17 her- alded an approaching crisis. Final- ly, the doctor treating the patient had been following him for seven months and was therefore familiar with him, was properly qualified, and did make an informed deci- sion. As the minority opinion pointed out, "the fact that hind- sight proves this judgment to have been an ill-fated one does not de- tract from its aptness at the time it was made." Case 4. A 27-year-old man had a history of six hospitalizations over a two-and-a-half year period (12). His admissions were usually pre- ceded by assaultiveness precipitat- ed by command hallucinations, and his diagnoses varied between man- ic-depressive disorder and para- noid schizophrenia. Although the patient was often uncooperative with clinic staff and frequently re- fused to take prescribed medica- tions, he had been stabilized on a combination of lithium and an anti- psychotic. The admission closest to the index -episode terminated on January 26, 1981. He was next seen on September 28, 1981. He had been arrested and was advised by his probation officer to seek treatment. On ex- amination he reported having com- mand hallucinations to rape some- one. He was examined by a physi- cian who had treated him previously. She concluded that de- spite his history of assaultiveness and poor compliance with medica- tion, he could be treated in a day hospital program. On October 7 the patient's dos- age of antipsychotic medication was decreased because of drug sen- sitivity (a finding the court later claimed was not supported in the medical record). His compliance with medication was poor, and his attendance at the day treatment program tapered off. He reponed- ly- took no medication at all be- tween November 9 and 30, the last day he was seen. On December 9, while attending a vocational reha- bilitation program, he stabbed a co-worker to death. Once again the trial court found that there had been more than an error in professional judgment. It supported this contention with ex- pert testimony on behalf of the plaintiff that institutionalization was the "only viable alternative" for the patient in September. (It is noteworthy that this testimony was given credibility despite being weakened on cross-examination.) The court felt that an "in-depth" evaluation would have confirmed the patient's unmanageability off medication (his lithium level was subtherapeutic) and that if profes- sional judgment had been used, the risks would have been identi- fied and the appropriate interven- tion implemented. The court also stated that the patient was under the "control" of the facility. It ignored the patient's participation in a day treatment program for more than a month and active participation in a voca- tional rehabilitation program at the time of the homicide. The record does not give any additional indica- tion of assaultiveness noted by the staffs of either program during this period. t Care 3. A 19-year-old outpa- tient with dual diagnoses of schizo- 'The decision in case 4.vu reversed by New York State's hiahest court after this paper was written. The Court of Appeals found that the fscn and circumstances did not prove neglijence and that .alid pro- fessional iudgnent was exercised. Whik closing no doors to litigation of subse- quent csses, the court clearly noted that the state's control over, and consequent duty to prevent harm by, a volunta" outpatient is more limited than its control over a hospitalized patient. phrenia and mental retardation was discharged from his fifth hospital- ization in March 1980 (13). His history included loss of behavioral control, temper tantrums, furni- ture throwing, and the use of sexu- ally abusive gestures. He was seen monthly by a psychologist (not li- censed according to state law) and quarterly by a psychiatrist. There is no evidence that the clinic had any knowledge of unusu- al behavior by the patient from March 1980 through February 1981. His mother reported no par- ticular problems but was said to minimize her son's pathology. Sev- en months after discharge the pa- tient began missing his scheduled appointments with the psychiatrist. His last visit with the psychologist occurred on January 26. On Febru- ary 1 he assaulted and raped a six- year-old girl and then threw her from a roof to her death. The claimant's expert testified that if the patient went off medica tions, he would inevitably become assaultive-and that the outpatient care was therefore insufficient and inadequate. If an appointment were missed, the expert claimed, the generally accepted standard would include four stepa: First, the patient should be called and re- scheduled to come to the clinic immediately (calls to reschedule appointments were, in fact, made). If the calls were unsuccessful, the help of a relative should be elicit- ed. Third, if the patient still did not show up, a team consisting of a social worker, an aide, and, if nec- essary, a doctor should be sent to the patlent's home. Finally, if all else failed, police assistance should be sought. If these steps had been taken, the expert concluded, the crime would not have occurred. The court accepted this unchal- lenged testimony, relative to both foreseeabiliry and causation, and found the state liable for both medical malpractice and negligent supervision. The duty to care for the patient, especially vis-a-vis monitoring his medication, was felt to have been violated. The treating doctor was chastised for an "almost cavalier" attitude, probably based Hospital and Community Psychiatry July 1986 Vol. 37 Na 7 727
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'to be demonstrated. Finally,- the clinical determination of the ap- propriate target population (31) ~would again involve a professional judgment. In summary, we must question whether the courts, increasingly uncomfortable with the violence perpetrated by patients in the com- munity, are seeking to hold psychi- atrists accountable for public poli- cy failures. A society that has dein- stitutionalized the care of the mentally ill while failing to provide adequate community care will have to accept the degree of risk accom- panying its actions. The five cases discussed here represent a poten- tial trend of far greater concern than the imposition of the TararoJf duty. They were not decided on the basis of new legal theory but rather on the basis of what is an unacceptably loose interpretation of negligence and malpractice law. Put simply, professional judg- ments about complex and volatile clinical problems will always lead to tragic results in a percentage of cases. However, the court deci- sions suggest that bad outcome may be equivalent to liability. Recommendations Since it is a fact of life that most clinical decisions about hospitaliza- tion, hospital passes, discharge, and the like involve an element of prediction, clinicians are obliged to more carefully manage the atten- dant risks (32). Some suggestions made previously by the first author (33) will be reiterated in the con- text of what has been learned from studying the five court decisions. Appelbaum (34) has correctly identified the information gather- ing and communication stages as crucial. In more than one case specific fault was found for the clinician's failure to obtain the patient's pre- vious medical record. Unfortu- nately this factor was overvalued by some experts, and testimony to the effect that key actions could not be taken in the absence of old charts was credited by the courts. We do not quarrel with the im- Porcance of previous information but do point out that decisions are made daily in emergency settings and elsewhere in its absence. Giv- en the brevity of most modern day inpatient episodes and the need to obtain patient consent for release of information before securing the data from another institution, psy- chiatrists cannot delay discharge peiiding receipt of records. When making medical judgments with- out the benefit of details about prior symptoms and treatment, cli- nicians should note the necessity for their actions. Some of the courts have given immense credence to past histories of specific dangerous behavior, even if the behavior happened years before. It may prove valuable for the practitioner to indicate in a note that he is aware of the specif- ics of the patient's history but does not consider them currently deter- minative. In two of the cases, the courts considered the clinicians profes- sionally remiss for not accepting almost at face value the statements of family members or the patients' friends. Because we are aware of the interpersonal psychodynamic factors that influence how events are reported by those closely in- volved with patients, we know that the courts overvalued such com- munications. The amount of credi- bility that should be attached to this type of data is another matter of judgment, but disregarding the data does not appear to be prudent unless one can clearly and carefully record why it is not worthy of belief. Nothing can be said in defense of poor communication among members of a treatment team. This contributed to several of the court decisions. Information that is not passed on to the clinician arho has ultimate responsibility for a patient is valueless. Entries in the medical record are crucial but should not take the place of verbal communi- cation. It cannot be said often enough that the best defense to allegations of malpractice is careful documen- tation. The details of one's clinical reasoning, written in a timely fash- ion, serve to indicate that a deci- sion was, in fact, the product of a professional judgment, assuming the patient was adequately evaluat- ed. When the clinician is in doubt about a clinical course, obtaining consultation from a colleague, who also places a note in the record, is also wise (to say nothing of the potential benefit to the patient). Misguided expert testimony was crucial to the outcome of some of the cases. Some statements seemed to confuse the witnesses' wishes with reality and to ignore the fact that standards are dictated, in part, by the resources available. Psychiatrists serving as expert wit- nesses inaccurately asserted that statements made by a schizophren- ic are by definition unreliable; there is only one viable course of action at any point in creatment; it is improper to discharge a psychot- ic person on his own recognizance; it is poor practice to give a pre- scription to a patient known to be reluctant to take medication; and a patient should be placed on one- to-one supervision in the absence of clear indications for this unusual step. In some cases the experts were not board-certified psychiatrists (35). It is time to suggest chat board certification be the mini- mum qualification for giving such crucial testimony or, at the least, a heavily weighted factor in the credibility given to the testimony. In addition, steps ought to be taken to ensure that a witness' experience matches the questions being asked. It is possible that some of the experts in these cases did not have recent experience > with the chronic population, as a result of which the patients may have seemed to be exceedingly ill. The American Psychiatric Associa- < tion's committee on peer review attempts to match reviewers' skills with the particular modality of treatment under scrutiny (Hamil- ton JM, personal communication, July 1985). Editors of professional journals routinely seek referees with highly specialized knowledge to advise them on the publication of submitted manuscripts. We be- Hospital and Community Psychiatry July 1986 VoL 37 Na 7 729
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Dr. Schwartz notes, however, that the DSM criteria for substance dependency "have been the subject.of controversy within the profession" and "in some ways, do not apply to the condition now referred to as nicotine dependence." (Dr. Schwartz Aff. J[ 6.) INTERROGATORY NO. 24: Regarding defendants' expert witness, Dr. Harold I. Schwartz, please define "Diagnosis" as it is used in his Affidavit. RESPONSE: Reynolds states that its inquiry with respect to this a information continues and,Reynolds will supplement its response upon completion of that inquiry. 1W - INTERROGATDRY NO. 25: rRegarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification, identify any individuals who discussed earlier drafts of these affidavits with the witnesses and describe the substance of these conversations. RESPONSE: Reynolds objects to this request to the extent that it seeks information protected by the work-product doctrine or attorney-client privilege. Subject to and without waiving its objections, Reynolds states that Dr. Schwartz, Dr. Townsend, and Mr. Iauco discussed drafts of their affidavits with counsel for Reynolds and Dr. Parrish discussed drafts of his affidavit with counsel for Lorillard Tobacco Company and Philip Morris Incorporated. INTERROGATORY NO. 26: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification, identify all individuals who assisted the witnesses in any way in the drafting of the affidavits and describe in detail the assistance rendered. RESPONSE: Reynolds objects to this request to the extent that it seeks information protected by the work-product doctrine or attorney-client privilege. Subject to and without waiving its cuaTOI Doc: 23n9o l 2 0
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Reynolds further objects to this interrogatory on the ground that it is unduly burdensome. Subject to and without waiving its objections, states that.Reynolds is unable to respond. Reynolds has Reynolds no reliable means of ascertaining how many New Yorkers smoke its cigarettes, much less how many smoke at least 16 cigarettes or a pack of Reynolds brand cigarettes per day. INTERROGATORY NO. 32: For each year from 1980 to the present, state (sic) identify which of your brands used reconstituted tobacco. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Subject to and without waiving its objections, Reynolds states that, since 1980, all Reynolds cigarettes have used, in varying amounts, reconstituted tobacco. INTERROGATORY NO. 33: For each year from 1980 to the present, identify which of your brands used a tobacco reconstitution process used or developed by LTR Industries, a subsidiary of Kimberly-Clarke corporation. RESPONSE: Reynolds objects to this interrogatory on the ground. that it seeks information that is irrelevant to the issue of class certification. Subject to and without waiving its objections, Reynolds states that it has not in the past and does not currently use any tobacco reconstitution process used or developed by LTR Industries. INTERROGATORY NO. 34: For each year from 1980 to the present, identify those brands, in which you added nicotine to the reconstituted tobacco that you used. CcuTOt o«: 2392901 2 3
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RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 14: Regarding all witnesses who have given affidavits.in•support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please describe any Research said witnesses has done relating in any way to nicotine addiction (however defined). RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 15: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please list all Presentations said witnesses has made or authored relating in any way to Nicotine Addiction (however defined):. For each, state: (a) the location of the Presentation; (b) the date of the Presentation; (c) who authored the Presentation; and (d) provide a description of the subject matter of the Presentation. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 10 as if fully set forth herein. INTERROGATORY NO. 16: Regarding all witnesses who have given affidavits in support of your motion to dismiss or opposing plaintiffs' motion for class certification or whom you or your attorneys expect to call at any hearing relating to class certification issues or a motion to dismiss, please list all writings, including but not limited to articles, non-referred articles, books, chapters, reviews, abstracts, letters, editorials, and unpublished writings relating in any way to Nicotine Addiction (however defined) for which said witnesses was the primary or contributing author. For each, state: (a) the author(s) as they are listed on the publication; (b) if it was published; cwrot n«: 23sz90 i 15
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Interrogatory Nos. 71-74 (among others) are more appropriately directed to British American Tobacco. Requiring Reynolds to search for information and/or documents most likely to be in the possession.of -others who are parties to this very action (or related class actions brought by plaintiffs) is not only an unjustifiable burden with no commensurate benefit to plaintiff, but, given plaintiffs' decision to serve the identical discovery to every party without d}fferentiAtion, is intentionally harassing. In addition, plaintiffs' interrogatories are unduly burdensome.insofar as tihey seek the samJ information.contained in documents produced in Castano v. The American Tobacco Companv, et Civil Action No. 94-1044 c/w 94-3000 (U.S.D.C. E.D. La.), brought by the same consortium of law firms who represent plaintiffs in this case. Under the protective order entered in Castano, plaintiffs' counsel here may use the Castano production in this case and any other smoking and health case they file. E. Plaintiffs' Instructions and Definitions Are Imorocer. Reynolds objects to plaintiffs' Instructions and Definitions to the extent that they purport to impose obligations on Reynolds that are different from and/or in addition to the CPLR. Reynolds will respond to plaintiffs' interrogatories in accordance with the CPLR and any orders of this Court. In addition, Reynolds objects to all of plaintiffs' definitions of the terms "addiction" or "addictive" because they are inconsistent with plaintiffs' definition and use of those terms in the Amended Complaint, which equates "addiction" with Cua'rot Do«: 239290 1 4
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confusing, and harassing. Plaintiffs go so far as to purport to require Reynolds to "describe in detail all research and other data which supports" Reynolds' position. The burden imposed by such a request far outweighs the probative value, if any, of the information sought. Reynolds further objects to this interrogatory on the grounds that DSM-IV does not use or define "addiction." Similarly, Dr. Schwartz's affidavit does not define the term "addiction," but refers to "addiction" only in the context of plaintiffs' use of that term. Subject to and without waiving its objections, Reynolds states as follows: (a)-(d) The terms "addiction" and "addictive" have no universally accepted medical or scientific definition. Usage of the term has changed dramatically over the years, and people continue to disagree as to what kinds of behavior are properly characterized as "addictive." While the scientific community once reserved the term "addiction" to describe the effects of such substances as opiates and alcohol, common usage of the term has expanded so that now numerous substances and repetitive activities have been labeled "addictive." It is this expanding definition of the term "addiction" that has made it possible for some persons to say that certain substances and behaviors, such as coffee, chocolate, jogging and overeating, can be "addictive." In 1964, the Surgeon General's Advisory Committee, released its report entitled Smokina and Health, Ch. 13 (U.S.D.H.E.W. 1964). This report, applying scientifically CLLITOI Doc: 239290 1 2 5
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any individual who forms a sincere desire to quit smoking can do so. Furthermore, cessation of cigarette smoking does not involve severe physical distress as does withdrawal from alcohol or classic drugs 'of'abuse, such as heroin and cocaine. Cigarette smoking also does not generate medically recognized tolerance as do classic drugs of abuse. In other words, cigarette smokers do not continually increase the amount that they smoke. ,ggg, e.g., 1964 Surgeon General's Advisory Committee Report at 354 ("once established there is little tendency to increase the dose"). And, cigarette smoking does not involve the destruction of family and business relationships, which is commonly seen with the consumption of alcohol or classic drugs of abuse. In sum, Reynolds contends that nicotine, according to any meaningful definition, is not "addictive." In addition, Reynolds states that plaintiffs' counsel already has access to voluminous documents relating to various issues concerning nicotine and "addiction" that were produced by Reynolds in Castano and may be used in this case pursuant to the Castano protective order. To the extent that this interrogatory purports to seek additional or different information, Reynolds objects to it on the grounds that it is overbroad, unduly burdensome, and seeks information that is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence. INTERROGATORY NO. 36: (a) Using the definition of "addiction" used by plaintiffs herein, what is the minimum level of nicotine in cigarettes at which at least some cigarette smokers who CuUmi noe: 2392901 2 7
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I _-C l: ,Di0)V+! l rDIC7w rION.t '4 ; on his statements that missed ap- pointments were not enough to cause him to worry about the pa- tient. We believe that the four-step action felt by the expert to be mandatory and• credited by the court goes far beyond the respon- sibility of any psychiatrist or clinic. In fact, it argues ultimately for preventive detention, a power that society will not vest even in the police. Discussion The five examples we have de- tailed are clinically analogous, even if not legally so. It is not our purpose to argue that the patients in these cases received the best care possible or that their treat- ment was error-free. We do con- tend, however, that their treat- ments were clearly within accept- able standards of medical practice. Only the unfortunate results were unpredictable. In each case the courts conclud- ed, with the benefit of hindsight, that a bad outcome stemmed from "something more" than an error in professional judgment; that is, that the poor result followed a failure to apply professional judgment to each patient's situation. With judi- cial sleight of hand, these courts not only challenged, but summari- ly dismissed, medical judgments. This rejection of psychiatric de- cision making, often with some assistance from members of the psychiatric profession, is no more than second guessing. It gives short shrift, if any cognizance at all, to crucially iarportant patient-related variablet. As such it does not rep- resent simply one more evolving malpractice risk but has the poten- tial for dramatically expanding psy- chiatric liability and eclipsing the duties outlined in Tarajoff. We believe that,the trend sig- naled by these cases is a symptom of society's growing need to attach liability to an individual or a group of individuals for the violent be- havior of a growing population of mentally ill citizens it will not ade- quately care for itself. The patients involved in these lawsuits received their care in the postdeinstitution- 728 alization era. In an earlier day they might well have spent large por- tions of their lives in state psychiat- ric hospitals where their violent impulses would have been out of sight. They are examples of those who have variously been called the new chronic patients or young adult chronic patients. This population has been well described in the psychiatric litera- ture (14-19). The clinical charac- teristics of its members are uni- formly ''reponed to include sub- stance abuse; impulsive, aggres- sive, and suicidal behaviors; in- volvement with the criminal jus- tice system; low tolerance of frustration; poor insight and judg- ment; and frequent crises. In terms of therapy, this dysfunctional and highly symptomatic group of peo- ple both use and abuse services offered. They are in and out of organized settings but are usually noncompliant. They are generally unwilling to accept the fact that they are ill or in need of treatment, as a result of which they commonly fail to keep appointments and fre- quently do not take their pre- scribed medications. These patients' clinical presenta- tions are often volatile and fluctu- ating, and the patients periodically pose a danger to themselves and others. Deciding what clinical ac- tion to take at any given time is a difficult medical judgment that must factor in numerous condi- tions that clinicians cannot accu- rately predict or satisfactorily con- trol. Two of the case decisions orig- inally rested on the clinicians' fail- ure to hospitalize and thus raise the issue of civil committaent. Vir- tually all jurisdictions require some form of dangerousness as a criterion for involuntary hospital- ization (20). Evidence indicates that physicians apply this criterion as the law requires, using relevant clinical daa (21). A large percent- age of individuals involuntarily ad- mitted have histories of some type of violent or fear-inducing behav- ior a couple of days prior to hospi- talization (22), and their subse- quent behavior may well corrobo- rate the decision to use inpatient care (23). However, many of the new chronic patients can be com. mitted at several points in their lives, and when to do so involves making a professional determina- tion. The literature on the difficulties inherent in predicting future be- havior, particularly dangerousness, is familiar to most mental health practitioners (24). It is also worth remembering that a person judged not dangerous in one context, such as the hospital, may behave quite differently in another, such as the community (25). Beck (26) reiter- ates the mathematical impossibility of true predictive accuracy, while Monahan (27) expresses guarded optimism that future, better fo- cused research will enable clini- cians to improve their abilities in this regard. Meanwhile there is much room for discretion well within the domain of professional judgment. People, not diagnoses or histories, can become violent. At some juncture, each inpatient must be considered for discharge. There comes a point, which often seems to lie in a gray area rather than a black or white one, when a patient no longer benefits from prolonged hospitalization: Many individuals will always remain at chronic risk of danger regardless of the interventiotis used and may appropriately be discharged de- spite relatively recent disruptive behavior. Public safety must be balanced against the research evi- dence indicating that for most pa- tients, indeed even for a state hos- pital cohort, long-term hospitaliza- tion is not justified (28,29). Commitment to outpatient care may be a partial answer for the future. Several of the decisions in the case reports evidenced the couru' belief that clinicians had some effective control over outpa- tients. Based on current data, out- patient commitment is rarely used, largely because of the lack of ade- quate provisions to implement and monitor any such order (30). Put simply, who would police compli- ance? In addition, the effectiveness of outpatient commitment has yet July 1986 Vol. 37 No. 7 Hospital and Community Psychiatry
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objections, Reynolds states that Drs. Parrish, Schwartz and Townsend and Messrs. Donahue and Iauco were each assisted in the drafting of their affidavits by counsel for Reynolds, Philip Morris or Lori-llard Tobacco. INTERROGATORY NO. 27: If earlier drafts of witnesses' affidavits submitted in the case no longer exist, describe in detail: (a) when those drafts were written; (b) how these drafts differ from the final version; (c) under what circumstances were these drafts lost or destroyed. RESPONSE: Reynolds objects to this interrogatory to the extent that it seeks information protected by the work-product doctrine or the attorney-client privilege. Reynolds will produce earlier drafts of its witnesses' affidavits, to the extent any exist and do not contain information protected by the work-product doctrine or the attorney-client privilege. INTERROGATORY NO. 28: For each year from 1980 to the present state the average retail price for which each brand of your cigarettes sold for in New York. RESPONSE: Reynolds objects to this interrogatory on-the ground that it seeks information that is irrelevant to the issue of class certification. In addition, Reynolds objects to this interrogatory on the ground that it is unduly burdensome and harassing because Reynolds does not sell its cigarettes at retail and does not set the retail price of its cigarettes. Reynolds sells its cigarettes almost exclusively to wholesale distributors. cLUToi Doc: 2392901 21
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INTERROGATORY NO. 29: For each year from 1980 to the present, state the range of retail prices for which each brand of your cigarettes sold for in New York. RESPONSE: Reynolds incorporates its objections and response to Interrogatory'No-. 28 as if fully set forth herein. INTERROGATORY NO. 30: For each year from 1980 to the present, state the approximate number of New York residents and/or citizens who smoked each brand of your cigarettes. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information'that is irrelevant to the issue of class certification, particularly in light of `the fact that Reynolds has not contested the issue of%class numerosity. r - Reynolds further objects to this interrogatory on the ground that it is unduly burdensome. Subject to and without waiving its objections, Reynolds states that it has no reliable means of ascertaining how many people in New York smoke Reynolds brands of cigarettes and accordingly, is unable to respond to this interrogatory. INTERROGATORY NO. 31: For each year from 1980 to the present, state the approximate number of residents and/or citizens of'New York who smoked: (a) 16 or more cigarettes manufactured by you per day on a regular basis; (b) at least a pack of cigarettes manufactured by you per day on a regular basis. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification, particularly in light of the fact that Reynolds has not contested the issue of class numerosity. CLMOI Doc: 239290 1 f-n ~ J J B J ~ 22 W CO
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RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Subject to and without waiving its objections, Reynolds states as follows: In response to consumer demand and public concern and criticism over the alleged health risks associated with smoking, Reynolds has, over time,d developed many technological innovations that have produced a progressive decline in sales-weighted .average "tar" and rticotine yields in cigarettes generally -- from 38 mg "tar" to 12 mg "tar" per cigarettb and"from 2.7 mg nicotine to 0.9 mg nicotine per cigarette. These "tar" and nicotine reductions have largely been achieved through innovations in cigarette design -- innovations pioneered by Reynolds and other members of the tobacco industry. Since the mid-1950's, Reynolds and other cigarette manufacturers have devoted extensive resources to achieve a general reduction in "tar" and the vapor phase components of cigarette smoke. Techniques incorporated in cigarettes over the last 40 years which reduce "tar" yields include: filtration reconstituted tobacco paper porosity reduced tobacco expanded tobacco filter ventilation tobacco blending These techniques have also significantly as well. reduced nicotine yields ct.t.tTOI noe: 2M90 t 3 4
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and (2) which brands of cigarettes contain sufficient nicotine to cause addiction. RESPONSE: Yes to all subparts. INTERROGATORY-NO-: 42: For each of the following years, state whether you believed that nicotine was addictive. If your answer to any subpart of this Interrogatory is "no," explain why the media reports and other public documents referenced in the affidavit of Michael E. Parrish failed to inform you of the addictive nature of nicotine. (a) 1900 (b) 1940 R (c) -1950 (d) 1960 ' 8, - (e) 1970 , (f) 1980 (g) 1984 1 . (h) 1988 ~ (i) 1990 (j) 1994 (k) 1997 RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Reynolds further objects to this interrogatory on the ground that the term "addiction" is vague, ambiguous and undefined. Subject to and without waiving its objections, . Reynolds states as follows: (a)-(k) No, for the reasons set forth in Reynolds' response to No. 35, which is incorporated as if fully set forth herein. Further, Reynolds states that the affidavit of Michael E. Parrish sets forth an historical overview and chronicle -- grounded upon newspapers, periodicals, government documents, school textbooks, and other public documents of the like -- demonstrating that, whatever the scientific and medical definitions of "addiction" were, the lay public had characterized CLUT01 Doc 23929ql 3 2
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regularly smoke that brand will become addicted to nicotine? (b) Using the definitions of "addiction" and/or "addictive" used in the 1988 Surgeon General's Report, what is the minimum level of nicotine in cigarettes at which at least-some cigarette smokers who regularly smoke that brand will become addicted to nicotine? (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, what is the minimum level of nicotine in cigarettes at which at least some cigarette smokers who regularly smoke that brand will become addicted to nicotine? , (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, what is the minimum level of nicotine in cigar8ttes at which at least sonie cigarette smokers who regularly smoke that brand will become addicted to,nicotineo r RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set forth herein. In addition, subject to and without waiving its objections, Reynolds states that, even assuming for the sole purpose of responding to this interrogatory that plaintiffs' definitions of "addiction"•are valid and proper, Reynolds is incapable of answering plaintiffs' hypothetical questions. • INTERROGATORY NO. 37: (a) Using the definition of "addiction" used by plaintiffs herein, what is the minimum level of nicotine in cigarettes at which at least some cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (b) Using the definitions of "addictive" and/or "addiction" used in the 1988 Surgeon General's Report, what is the minimum level of nicotine in cigarettes at which at least some cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, what is the minimum level of nicotine in cigarettes at which at least some cigarette smokers cwroI Doc: xM9o 1 2 8
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cigarette smoking and nicotine as "addictive" or an "addiction" since at least the turn of the century (if not before). The term "addiction," however, has significantly different meanings in the scientific and medical community than it does in the lay vernacular. Dr. Parrish's affidavit is not -- nor does it purport to be -- an overview of scientific, medical and/or technical literature concerning whether, under well- defined, meaningful criteria nicotine can be considered "addictive." Nor does Dr. Parrish, a historian, purport to provide an expert opinion on the issue of "addiction." Dr. Parrish's conclusion that the lay public had long labeled smoking as an "addiction" or "addictive" should not be confused with a scientific or medical determination of that issue. INTERROGATORY NO. 43: For each year from 1980 to the present, list the nicotine level for each of your brands of cigarettes. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Subject to and without waiving its objections, Reynolds states that nicotine yields, "tar" yields and (more recently) carbon monoxide yields are reported annually to the FTC which, in turn, periodically releases reports containing the tar and nicotine yield for each brand and style of cigarettes manufactured and sold in the United States. Reynolds will produce copies of each FTC report issued since 1980. INTERROGATORY NO. 44: For each year from 1980 to the present, describe any changes that were made regarding the ni}cotine level for each of your brands of cigarettes. CLUT01 Doe: 239290 l 3 3
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Design changes such as the development of more porous cigarette paper, improved filtration, and the use of expanded tobacco and reconstituted tobacco made general reduction possible. By-utilizing one or more of these techniques, Reynolds can offer smokers a wariety of cigarettes with a wide range of "tar" and nicotine levels. Cigarette designers have been so successful in their efforts to respond to the demand for these reductions'that today there are commercially available cigarettes that yield "tar" and nicotine at levels so low they cannot be measured reliably by the FTC's standard procedure.' Each of the above cigarette design techniques has been well-publicized and known to the government, public health, scientific and even lay communities. More recently, the scientific and public health community, including the Surgeon General and at least one foreign governmental public health committee, have encouraged the research and/or development of cigarettes with lower "tar" to nicotine rations. In response to these suggestions, Reynolds has devoted research to reducing the "tar" to nicotine ratio of cigarette smoke. Reynolds was able to develop cigarettes in the laboratory that lowered this ratio beyond that in commercially available cigarettes, and it was granted patents on some of the processes it employed to do so. Reynolds, however, was not able to develop a commercially-acceptable cigarette using these processes. Reynolds has also developed or used processes that result in the removal of substantially all -- but not all -- of Cuxrot Doc: x3929o t 3 5
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subject to and without waiving its objections, Reynolds states that, even assuming for the sole purpose of responding to this interrogatory that plaintiffs' definitions of "addiction" are valid and proper-., Reynolds is incapable of answering plaintiffs' hypothetical questions. INTERROGATORY NO. 39: (a) Using the definition o.f "addiction" used by plaintiffs herein, what is the minimum level of nicotine in cigarettes at which virtually all cigarette smokers who regularly smoke 16 or more'cigarettes a day will become addicted? ~ - (b) Using the definitions of "add~ctivS" and/or "addiction" ,used in the ~988 Surgeon Gene al's Report,.what is the minimum level of nicotine in cigarettes at which virtually all cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, what is the minimum level of nicotine in cigarettes at which virtually all cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, what is the minimum level of nicotine in cigarettes at which virtually all cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set forth herein. In addition, subject to and without waiving its objections, Reynolds states that, even assuming for the sole purpose of responding to this interrogatory that plaintiffs' definitions of "addiction" are valid and proper, Reynolds is incapable of answering plaintiffs' hypothetical questions.
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P_F_ ~ associated with hospital admission. Hospital and Community Psychiatry a 36:643-647. 1983 - 23. Roftnatt ES, Askinazi C, Pant E: The prediction of dangerous behavior in emergency civil commitment. Ameri- can Journal of Psychiatry 137:1061- 1064,1980 24. Monahan J: The Clinical Prediction of Violent Behavior. DHHS Publication ADM 81-921. Washington, DC, US Government Printing Office, 1981 25. Stokman CIJ: Dangerousness and vio- lence in hospitalized mentally ill of- fenders. Psychiatric Quarterly 56:138- 143. 1984 26. Beck JC: Psychiatric assessment of po- tential violence: a reanalysis of the problem, in The Potentially Violent Patient and the Tarasoff Decision in Psychiatric Practice. Edited by Beck JC. Washington, DC, American Psy- chiatric Press, 1985 27. Monahan J: The prediction of violent behavior. toward a second generation of theory and policy. American Journal of Psychiatry 141:10-1 S, 1984 28. Mattes JA: The optimal length of hos- 29. pitalization for psychotic patients: a review of the literature. Hospital and Community Psychiatry 33:824-828, 1982 Caton CLM: Effect of length of inpa- tient treatment for chronic schi:ophre- nia. American Journal of Psychiatry 139:856-861, 1982 30. Miller RD, Fiddleman PB: Outpatient commitment: treatment in the least restrictive environment? Hospital and Community Psychiatry 35:147-151, 1984 31. Miller RD: Commitment to outpatient treatment: a national survey. Hospital and Community Psychiatry 36:265- 267, 1985 32. Kroll J, Mackenzie TB: When psychia- trists are liable: risk management and violent patients. Hospital and Cotnmu- nity Psychiatry 34:29-37, 1983 33. Rachlin S: Double jeopardy: suicide and malpractice. General Hospital Psy- chiatry 6:302-307, 1984 34. Appelbaum PS: Tarasoff and the clini- cian: problems in fulfilling the duty to protect. American Journal of Psychia- try 142:425-429, 1985 3S. American Psychiatric Association Bio- gnphical Directory. Washington, DC, American Psychiatric Associatiors, 1983 36. Mills MJ: Expanding the duties to pro- tect third parties from violent acts. New Directions for Mental Health Services, no 25:61-68, 1985 37. Youngberg v Romeo, 457 US 307, 102 SCt 2452, 73 LEd2d 28 (1982) 38. Appelbaum PS: Rethinking the duty to protect, in The Potentially Violent Pa- tient and the TarasoB Decision in Psy- chiatric Practice. Edited by Beck JC. Washington, DC, American Psychiat- ric Press, 1985 39. Rachlin S, Miller RD: Reinstitutionali- ution. American Journal of Social Psy- chiatry S(3):60-64, 1985 The Evolution and Effectiveness of Telephone Counseling Services Andrew R Hornblow, Ph.D. Despite dramatic expansion of telephone counseling services during the last three decades and widespread belief in their pre- ventive and therapeutic value, empirical evidence of their effec- tiveness is limited, partly because of methodological and practical difficulties associated with n- searcb in the fxld A review of existing studies indicates that telephone counselors may perforst valuable listening, informatio>l Dr. Hornblow is associate pro- fessor and chairman of the De- partment of Community Health, P.O. Box 4345, Christchurch Medical School, University of Otago, Christchurch, New Zea- land. giving, and referral roks. Evi- dence is lacking, however, on tbe ability of telepboxe counseling to produce behavior change in call- ers or to reduce suicide rates. Re- cent studies indicate that con- tract telepbone counseling may have coasiderable tberapextic po- tential for moxitori>:g and sxp. portiwg clients with ongoing problems or cbronic disabilities. The development of new services for the delivery of health care re- sults as much from unstructured social processes as from careful planning by health care providers. Historically new strategies for community support have evolved in response to a heightened aware- ness or changed perception of hu- man need. Increased public con- cern over the ravages of infectious diseases and poverty, coupled with concerted voluntary effort and subscription, provided the major impetus for the development of a network of hospitals in 18th-cen- tury England (1). The advocacy and enthusiasm of reformers such as Dorothea Dix and Clifford Beers were major factors in the evolution of mental health care in the United States (2). The recognition, outside estab- lished psychiatric services, that the psychosocial stresses of 20th-cen- tury life may be alleviated through support offered by telephone re- sulted in the establishment of tele- phone counseling services and their dramatic growth during the last three decades. The Samaritans, established in London in 1953 with suicide prevention as their primary aim, expanded in 20 years to be- come an international organization with 17,000 volunteers and ap- proximately 150 branches offering walk-in and telephone services (3). Hospital and Community Psychiatry July 1986 Vol. 37 No. 7 731
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RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Furthermore, Reynolds objects to this interrogatory-ori-the grounds that the term "added" is vague and ambiguous. Subject to and without waiving its objections, and assuming that by the use of the word "added" plaintiffs intended to ask whether Reynolds "spikes" or "increases" the nicotine content of the tobacco used to malCe cigarettes by the addition of extraneous nicotine to the reconstituted toba~co process, Reynolds states that it makes no such brands. INTERROGATORY NO. 35: • (a) Using the definition of "addiction" used by plaintiffs herein, do you contend that nicotine is not an addictive substance? Describe in detail all research and other data which supports that position. (b) Using the definitions of "addiction" and/or "addictive" used in the 1988 Surgeon General's Report, do you contend that nicotine is not an addictive substance? Describe in detail all research and other data which supports that position. (c) Using the definition of "addiction" and/or "addictive" used in DSM IV do you contend that nicotine is not: an addictive substance? Describe in detail all research and other data which supports that position; and (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, do you contend that nicotine is not an addictive substance? Describe in detail all research and other data which supports that position. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds also-objects to this interrogatory on the grounds that it poses an improper hypothetical question in fact discovery of a nonexpert and is-unduly burdensome, cwTOI Doc: 239290 1 2 4
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accepted criteria, declared unequivocally that smoking was no addictive, but was more properly characterized as a habit. This remained the position of the Surgeon General for many years thereafter until, in 1988, the Surgeon General significantly changed position and declared smoking to be "addictive." The 1988 Surgeon General's Report changed his position on smoking and "addiction" by significantly changing the definition of "addiction" it employed from that,used in the 1964 Report. Thus, while cigarette smoking behavior has not changed, the labels used by public health authorities to describe that behavior have. Reynolds contends that, under *ny traditional, r scientifically appropriate view of "addiction," which includes requirements of intoxication, compulsion (i.e., seeking to obtain the substance through any means necessary), physiologically significant withdrawal, and tolerance the need for an ever-increasing dose to achieve the same psychoactive effect), nicotine is not "addictive" and no brand of cigarettes was or is "addictive." Definitions of "addiction" that fail to acknowledge fundamental distinctions among behaviors, however, obscure rather than clarify analysis. cigarette smoking behavior is fundamentally different from addiction to alcohol or illegal drugs. Cigarette smoking is not intoxicating and does not impair an individual's ability to make voluntary choices about whether to abstain from or continue smoking. Indeed, the fact that almost 50 million Americans have quit smoking is a convincing demonstration that smokers are not compelled to smoke and that CLUT01 Doe: 299290 1 2 6
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INTERROGATORY NO. 47: Do you contend that your company is unable to reduce nicotine levels in cigarettes below the level in its lowest nicotine brand? If yes, explain why this is technologically impossible. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Subject to and without waiving its objections, Reynolds states: No, but this process would be commercially infeasible for the reasons set forth in Reynolds' response to Interrogatory No. 44, which is incorporated as if fully set forth herein. INTERROGATORY NO. 48: If ammonia is used in the process of manufacturing any of your cigarettes, describe its purpose in that process, including any relation/interaction that it has with nicotine. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Subject to and without waiving its objections, Reynolds states that ammonia compounds are used as a processing agent in the reconstituted tobacco sheet manufacturing process. To the extent that this request purports to seek additional or different information, Reynolds further objects to it on the grounds that it seeks highly confidential, trade secret information without any showing of need -- much less compelling need -- for such information. INTERROGATORY NO. 49: For each year from 1980 to the present, identify all ingredients (including ammonia) in each of your brands of cigarettes that could either (a) increase the amount of nicotine extracted from the cigarette and delivered to the smoker; and/or (b) increase the speed and/or total amount of nicotine absorbed by the smoker.- Urol Doc: 299z90 1 7 Ln N -J -J m -J G Ln w
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NiCOTL.`E DEPENDENCE 31. Ro:1:.ille. Md. \attonal Inctttute on Drue Ai`u.c. 1-5. rr 3--:' 1171 1e=. Pnmerieau OF. Pomrrleau CS: \runtrcculau.r, anJ the rem.- ior.ement ot smoianc: rowards a iani-rhaciarai expiananur. \euros.i Biobehav Ret 1yX4: 5:>0?-~1? IF, 163. Sutherland G. Stanieron JA. Russell MAH. Feveraivnd C: \a?- tre.one. smokms: ixhat-tour and acarenr.t•tritdrast•al. Pst,ht- pharmacolop- iBerl: 1`tQ5: l-'0:41N-i_5 JAI 164. Fuller RK: Antidipsotropt, medtanons, in Handbook ot Alru- holism Treatment Approaches: Eftecan•e alternan.es. Edited h% Hester RK. Jiiller \CR. New York. Percamon Press. 1984. prr 11"-1,- IFI. 165. Gourla}. 5G. Benowitz \L: Is clonidine an eftectit•e smoking cessation therapy? Drugs 1995: j0:1Q'--'0' IEI 166. Parrott AC: Stress modulation over the day in cicarette smokers. Addiction 1995: 90:?3 3-24-t IG) 10-. Hall SM. Munoz RF. Reus VI. Sees KL: Nicotine. nrgattt•e at- ten. and depression. J Consult Cltn Psychol 1993: 61 '61= t,-/FI 168. Humtleet G. Hall S. Reus V. Sees K. Mufloz R. Triftleman E: The efficacy ot nortnpn•line as an adlunet to psychological treatment for smokers with and without depressive histones, in Problems of Drug Dependence. 199:: NIDA Research \lono- graph, vol. 162. Edited by Adler M. Ro:kt•ille. Md. National Institute on Drug Abuse. 1996, p 334 IAI 169. Robinson MD. Anastasio GD. Little J\l. Sigmon IL. \tenscer D. Pertice YJ. Norton HJ: Ritalin for nicotine withdrawal: Nes- bttt's paradox revisited. Addict Behav 1993. 20:481-490 IBI 1-0. Rose JE. Behm F\l: Inhalation of.•apor from black pepper ex- tnct reduces smoking withdrawal symptoms. Drug Alcohol Dc- pend 1994: 34:::5-229 I A 1 1'l: Behm F.M. Rose JE: Reducing craving for cigarettes while de- creasing smoking intake using capsaictn-enhanced low tar ciga- rettes. Exp Clin Psychopharmacol 1994: 2:14:-153 JAI 1-2. Butschk.•.\iF. Bailey D. Henningfteld JE. Pickworth V1'B: Smok- ing without nicotine deliverr decreases withdrawal in 12-hour abstinent smokers. Pharmacol Biochem Behat• 1995: i0:y1-96 JAI 1'3. Lerin ED. Behm F\l, Rose JE: The use of flavor in cigarette substitutes. Drug:llcohol Depend 19y0:26:1.+=-16(1IAI 1'4. Behm FSI. Levin ED. Lee YK. Rose (E: Low-nicotine regener- ated smoke aerosol reduces desire fur cil;arettes. J Suhst Abuse 1990; 2:23'-24' I aI 1-.i. Westman EC. Behm FJI. Rose JE: Airway sensor.• replacement combined with nicotine replacement fur smoking cessation. Chest 1995; 107:1358-1364 JAI 1-6. Behm F.M, Schur C. Levin ED. Tashktn DP. Rexc.IE: Clinical evaluation of a citric acid inhaler for smoking cessanon. Drug Alcohol Depend 1993: 31:131-138 I aI 1--. Schwartz JL: Evaluation of acupuncture as a treatment for smoking. Am J Acupuncture 1988: 16:135-142 IE/ 178. Ter-Riet G. Kleininen J, l:ntpschild P: A meta-anal.•sis ot studies into the effect of acupuncture on a,ddiction. Br J Gen Pract 19911: 40:379-382 IE) 1'9. Glasgow RE, Klesges RC. Klesges L.M, Vasev\iVt', Gunnarson DF: Long-term effects of a controlled smoking program: a'J3 year follow-up. Behavior Therapy 1985; 16:303-307 IFI 180. Hall SM, Munoz RF, Reus VI: Cognitive-behavioral interven- tion increases abstinence rates for depressive history smokers. J Consult Clin Psychol 1994; 62:141-146 IA I 181. Dalack GW. Glassman AH: A clinical approach to help psychi- atric patients with smoking cessation. Ps>•chiatr Q 1992a 63:2-- 38IG1 - 182. Fiore MC, Novomy TE, Pierce JP. Giovino GA. Hatziandreu EJ, Newcomb PA. Surawicz TS, Davis RM: Methods used to quit smoking in the United States. JAhIA 1990;263•?760-2765 IGI 183. Hughes JR: Problems of nicotine gum. in Pharmacologic Treat- ment of Tobacco Dependence: Proceedings of the World Con- gress, November 3-5, 1985. Edited by Ckkene JK. CambridFe, Mass, Institute for the Study of Smoking Behavior and Policy. 1986, pp 141-147 IFj 184. Tonnesen P, Fryd V. Hansen M. Helsted J. Gunnersen A. For- chammer H. Stockner M: Effect of nicotine chewing gum in 30 1N.; - a•^Sr•tnatlt,.^. \\ Ir.-1 L • ~ .. . ..-. . .... .. •. . . . . . - N Lnc I N Ir.. I- 1. `I ialier. a trcamun: tkinattarai trratmrnt• tu: .nuo.:n, rc.an,: r t.: :.. Cim 1'c%:nn( 1 ah. Hu_nc• IK: .m.,ictn_ anJ at:unain^:. r: Iw t~: t, r.:. 1^r .... . ncrs. IJ1-i, Fp 1-3 , i IS-. ( uuria. >(;. farrr, A. \larri:.cr T. I;:n:;a 1). \l. \.. 1 i: E~. . ble i•Itn. ii trtai ur rrrKatr.: trra:mr::: %%::r. r....".:. tar rriarsrJ .mokrr.. Br \Ir.i I IJ": ~1 -A 18S. Tanneaen 1'. \t.rrcc.tar.i I. !mtt r I.Nitm•a.-,•,:1.: l Ai I e". Hurt RD.1)ale 1V. OfturJ F:I'. hru.r Rl.. \ 1; k ..u:: F l. F KM: Inpatient treatment ot .rterc n:;t1t,nc Clin PnI. IJJ_'• h-:,:?-8., II+; 1411. Resnitk \1P: Treating nt:ottnr aJJi:uan n: panrnt.wnit I•..- :htatrt: :u-mnrhiJttn. in \trortnr aJJt:nun: 1'nn;tpit, \lanaeement. Edited hr (lrlratn ('1. >IaJ: II). \r.% 1 uri.. tI\ turJ l)ntt•ersrty Press. 1'rJ.O. rr ?: -I , ih if : 191. HuLhrs JR. Hqyl;m> ST. Bt:krl \C•L.: \tamnr tt-tthJr.t%% A % rr.r• other dru,t• wrthJrawal <t•nJramr.: amtlannr• an,i Jt.wnuat ties. aJJtcttan> lyua: 8":I4hI-Ia'u IF; ly_: Haring C. Barna> C. Sarta A. Humjv1 (.. }Iri.;hhaa.cr \\ \\ L)ose-relatrJ plasma lrvrl, ut :ittiarmc. I(:hn I'.t;hurharnt.t col 198y: y:-1--: IGI 193. Working Group tar the StuJs at Tran.Jrmtal Ntaatna• tn I'.t tients With Coronary Artrn 11nra%r: Naunnr rrpla:rmrn: therapy for pattents with .unman artcn. Jt.casc. Arch Imcn: \LrJ 1944; 1 33 :yil`r-y9i JAI 144. Hurt RD. Eberman K\l. C:nq;han IT. (lfturJ 1:1', l)avt. 1.1 It. \lnrse R\l. Palmen XtA. Bruce Bi:: \tcttnnr JeprnJencr trc.u • mrnt during inpatient treatment ttx taher a.Ww~tttau: a pnssprc- nve intervention trial. Alcohol Chn Exp Rea 1994. 18:8d =~': IBI 1 y;. Hall SM. Munoz RF. Rru. \'1.%ce. Kt.: SIIU,J manaFemtMn and nicotine gum in smoking treatment: a therapeuttc cunta:t anJ placehu cuntrolleJ stuJv. J Consult Chn Pcy;hal tin pressl JAI 146. Lohr JB. Flynn K: Smuktnp anJ .:htraphrrnta. %:hwuphr Rr• ly . lyy_: IL]_ IFI l'S brpartmrnt of Health anJ Human %rrttce.: I'sc:hnlul;t:.tl and hehartoral conseyutm<-m and currelate% ot smoking cr..a- non, in Health lienrtit% of smoktng C:essannn: A Report ut thc l'S Surgrun (I'c ncraL \C•ashtnjgrun. D(:. US Govrrnmrnt 1'nnnn, uffi:e. 14100. pp 31'-3'% IfI 198. .anthunuen NR. Cunnrtt Jt. Kilrt• 11'. Aln»r \1l). Bailr>• \\'(.. 194. Butst AS. Cun.ray WA Jr. F.nril;ht PL. Kanntv RE, O'Hara 1'. C1arn. GR. Scanlun PU. Tashktn UI'. \C'isr RA: Efh.a uf smu{,- me intervention and thr use of an mhaleJ antichobnrrl;k hrun- .hudilator un the ratr of Jt-.hnt• ttt FF.\'I: thr l.un}; Health titudc. JAMA lyy4:-__:149--1311i IAI Krnned}• JA. Crowley Th Cnrtkr 1.11, Slager DE: Substancr use diagnoses in smokers with lung diseasr. Am J Addiction 1993; 2:12a-1311 IGI 200. Rimer BK. Orleans CT: Older smokers, in Nicotine Addiction: Principles and Management. Edited by Orleans C,T. Sladr.11). New York. Chftxd Umversitv Press. 1993. Ppp 38S-39S IFI 201. Rimer BK. Orleans C.T. Flcishcr L. (:risnnziu S. Resch N,Tckp- chak J, Keintr. X1K: lkm tailoring matter? the impact of a tai- lored guide on ratings and short-term smoking-related nut- comes fur older smokers. Health Education Res 1994; 9:69-84 JAI 202. Repsher LH. Transdernwl Nicotine Study Group: Smoking ces- sation by women and older persons: resuhs from the Transder- mal Nicotine Study Group. Modern Medicine 1994; 62:34-38 IA) 203. Solomon LJ, Flynn BS: Women whu smoke. in Nicotine Addic- tion: Principles and Management. New York. Oxford Univer- sin• Press. 1993, pp 339-349 IFI 204. Grunherg NE. Winders SE, Wewen .%lE: Gender differences in tobacco use. Health Psvchol 1991; 10:143-153 IF) Am J Psychiatry 153:10, October 1996 Supplement 51770 6921
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J. Donald deBethizy, Ph.D. Research and Development Department R.J. Reynolds Tobacco Company Bowman Gray Technical Center 1100 Reynolds Boulevard Winston-Salem, North Carolina 7102 John H. Robinson, Ph.D. Research and Development Department R.J. Reynolds Tobacco Company Bowman Gray Technical Center 1100 Reynolds Boulevard Winston-Salem, North Carolina 7102 William Caldwell, Ph.D. Research and Development Department R.J. Reynolds Tobacco Company Bowman Gray Technical Center 1100 Reynolds Boulevard Winston-Salem, North Carolina 7102 David E. Townsend, Ph.D. Research and Development Department R.J. Reynolds Tobacco Company 401 North Main Street Winston-Salem, North Carolina 27102 INTERROGATORY NO. 55: Identify all officers, directors, managers, public relations persons, and corporate spokespersons or other corporate representatives who made public statements (orally or in writing) regarding nicotine and habit and/or nicotine and addiction (including any statements regarding whether or not nicotine is an addictive substance, and regardless of the definition of "addiction" used by the speaker). RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Public statements on nicotine and "addiction" are clearly relevant only to the merits, or lack of merit, of plaintiffs' claims. Reynolds further objects to this interrogatory on the ground that it is unduly burdensome in that it purports to require the production of any "public statement," including oral statements, on the subject described. CLUTOt Doc: 299290 I 41
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416 ApFENDIX 8 ~- : 0 During or after stressful situations O During social occasions O Other-specify ~~-- .~. 2.13 Do you find it difficult to keep fQm smoking in plares where it is forbidden (for example ;• . in church, at the movics)? V 1 T T, worse by your smoking? O No O Yes _ 2.14 In wbat situatioas don't you smoke?-L'heck as many ar. apply., - O In public O At work O At home O In presence of certain relatives (e.g., parents, grandparents, in-laws) rJ In presence of my children ~ At rnretings O Inside the home of non-smokers L In my car when non-smokers are with me u l n other peoples' cars O In restaurants ` In a.irplar.cs sxcify ~. ;: Pleas~ . nd:ca:e w•iether or not you think you would smoke in :;e fol'owin?_ sit~.:ations~ ~ W'oilid :.:t N'•..11... Situation sCI'.oiC: lJflsllrr sr.-.o/Ce 1. w nen feeling anxious or under a lot of stress 0 0 0 ?. rWhen wanting something in your mouth 0 0 1 3. w'hen relaxing 0 0 ` 4. When wanting to cheer up 0 p L; _. When wa:lting to keep busy ~ . O 0 6. When bored or trying to pass the time G G' 0 7. When around other smokers 0 0 0 8. When drinking alcoholic beverages i 1 0 0 9. When drinking coff'ee or tea 0 0 G 10. When talking on the telephone 0 p O 11. When in pain 0 0 0 12. ARer meals 0 0 O 2.16 Have you in the past had symptoms. a disease or illne.cs ynu believe was caused or made O No O Yes, please describe 2.17 Do you now have symptoms, a disease or illness you beheve is caused by or made worse by your smoking? O lti o 0 Yes, please describe ,... . . . 2.18 Does your dncirre for a cisazette ever ditrupt the activities you ore involved iq? .= O No O Yes 2.19 Do you lose time from work or other planned activities because of cmoking? ONo O Yes, describe -
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599 Lexington Avenue New York, New York 10022 Robert W. Gaffey Harold K. Gordon (212) 326-3939 Attorneys for Defendant R.J. Reynolds Tobacco Company 0 r . CLutot Doc: x3sM1 50
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that you funded or participated in along with other cigarette manufacturers. RESPONSE: Reynolds incorporates its objections and responses to Interrogatory No. 51 as if fully set forth herein. INTERROGATORY NO. 54: Identify the person within your company who has the greatest knowledge of: (a) the habit forming and/or addictive properties of nicotine (including whether or not nicotine is an addictive substance); . (b) ways in which the levels of nicotine in cigarettes have been controlled between 198*0 and the present; and (c) all research involving nicotine. r % - - RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. The identity of the persons sought in this request can have no bearing on the class certification requirements under CPLR 901. Finally, Reynolds objects to plaintiffs' use of the term "greatest knowledge" as vague and ambiguous. Subject to and without waiving its objections, Reyi1olds states that employees of Reynolds Research and Development Department are expected to be familiar with and maintain currency with scientific and medical literature (including literature relating to the individual subparts of this interrogatory) relevant to their areas of responsibility. Accordingly, some employees are more knowledgeable in certain areas than others, and the converse is also true. Employees who have general knowledge relating to the subject-matter of this interrogatory are: CLLIT01 Doe: 299290 1 4 O
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who regularly smoke 16 or more cigarettes a day will become addicted? (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, what is the minimum level of 'nicotine in cigarettes at which at least some cigarette smokers who regularly smoke 16 or more cigarettes a days will become addicted? RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set forth herein. In addition, subject to and without waiving its objections, Reynolds states that, even assuming for the sole purpose of responding to this interrogatory that plaintiffs' definitions of "addiction" are valid and proper, Reynolds is incapable of answering plaintiffs' hypothetical questions. INTERROGATORY NO. 38: (a) Using the definition of "addiction" used by plaintiffs herein, what is the minimum level of nicotine in cigarettes at which the majority of cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (b) Using the definitions of "addictive" and/or "addiction" used in the 19$8 Surgeon General's Report, what is the minimum level of nicotine in cigarettes at which the majority of cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, what is the minimum level of nicotine in cigarette$ at which the majority of cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, what is the minimum level of nicotine in cigarettes at which the majority of cigarette smokers who regularly smoke 16 or more cigarettes a day will become addicted? RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set.forth herein. I In addition, cwmt D«: z3929o t 2 9
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ground that the term "addiction" is vague, ambiguous and undefined. Subject to and without waiving its objections, Reynolds incorporates its response to Interrogatory No. 35 as if fully set forth fierein. INTERROGATORY NO. 60: Identify all communications -- whether written or oral -- between you and the Tobacco Institute ("TI"), regarding nicotine and addiction or nicotine and habit (regardless of the definition of "addiction" used by the speakers). . RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant too the issue of class certification. Reynolds further object`s to this interrogatory on the ground that the term "addiction" is vague and ambiguous and improperly and inadequately defined in plaintiffs' instructions. INTERROGATORY NO. 61: Identify all communications -- whether written or oral -- between you and the Council for Tobacco Research regarding nicotine and addiction or nicotine and habit (regardless of the definition of "addiction" used by the speakers). RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the ground that the term "addiction" is vague and ambiguous and improperly and inadequately defined in plaintiffs' instructions. INTERROGATORY NO. 62: If you, now or in the past, has (sic) any written policy that discusses "drug addiction" or "drug dependence," how are those terms defined in that policy?
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all documents in your possession which support the position that nicotine is not an addictive substance. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Documents that support Reynolds' position on nicotine and "addiction" are the very definition of an inquiry on the merits, not discovery that relates to class certification. Subject to and without waiving its objections, Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set forth herein. INTERROGATORY NO. 59: (a) Using the definition of "addiction" used by plaintiffs herein, identify all documents in your possession which support the position that nicotine may be or is an addictive substance and/or a habit forming substance. (b) Using the definitions of "addictive" (sic) and/or "addictive" used in the 1988 Surgeon General's Report, identify all documents in your possession which 'support the position that nicotine may be or is either an addictive substance and/or a habit forming substance. (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, identify all documents in your possession which support the position that nicotine may be or is either an addictive substance and/or a habit forming substance. (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, identify all documents in your possession which support the position that nicotine may be or is either an addictive substance and/or a habit forming substance. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certificationi Requesting documents that support plaintiffs' position is obviously merits "discovery," not class certification discovery. Reynolds further objects to this interrogatory on the cLuroI Doe: x39no_i 4 3
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the nicotine naturally occurring in tobacco. The processes developed to remove substantially all nicotine from tobacco have never been applied on a commercial scale by Reynolds and are extremely costly. Based on Reynolds' consumer testing of experimental cigarettes developed using these processes and the failure in the marketplace of Philip Morris' NEXT product, Reynolds does not believe that cigarettes from which substantially all nicotine has beAn removed from the tobacco are commerciallyfeasible. INTERROGATORY NO. 45: For each year from 19$,0 to the present, describe the process byf which you contrJlled the niccttine level for each of your brands of cigarettes. RESPONSE: Reynolds incorporates its response to Request No. 44 as if fully set forth herein. Reynolds further states that it employs leaf selection and blending techniques to ensure the overall consistency of its products, including nicotine yields, and to ensure compliance with FTC requirements regarding "tar" and nicotine yields. • INTERROGATORY NO. 46: (a) Have-you ever researched, manufactured, promoted and/or sold a cigarette that does not contain any nicotine. If the answer to this Interrogatory is yes, describe in detail why that cigarette was never marketed and/or why it is not presently marketed. (b) Have you ever researched, manufactured, promoted and/or sold a cigarette that contains significantly less nicotine than any cigarette that you are currently marketing? If the answer to this Interrogatory is yes, describe in detail why that cigarette was never marketed and/or why it is not presently marketed. RESPONSE: Reynolds incorporates its response to Interrogatory No. 44 as if fully set forth herein. cuami Doc: 2M90 i 3 6
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INTERROGATORY NO. 40: (a) For each year from 1980 to the present, identify those brands of your cigarettes that are capable of causing nicotine addiction. (b) Using the definitions of "addictive" and/or "addiction" used in the 1988 Surgeon General's Report, for each year from 1980 to the present, identify those brands of your cigarettes that are capable of causing nicotine addiction. (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, identify those brands of your cigarettes that are capable of causing nicotine addiction. (d) Using the definitions of "addiction" and/or "addictive" .used in the affidavit of Dr.. Harold Schwartz, identify those brands of your cigarettes that are capable of causing nicotine addiction. RESPONSE: Reynolds incorporates its objections and responses to Interrogatory No. 35 as if fully set forth herein. INTERROGATORY NO. 41: (a) Using the definition of "addiction" used by plaintiffs herein, do you contend that this court cannot determine on a classwide basis: (1) whether nicotine is an addictive substance; and (2) which brands of cigarettes contain sufficient nicotine to cause nicotine addiction. (b) Using the definitions of "addictive" and/or "addiction" used in the 1988 Surgeon General's Reports, do you contend that this Court cannot determine on a classwide basis: (1) whether nicotine is an addictive substance; and (2) which brands of cigarettes contain sufficient nicotine to cause addiction? (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, do you contend that this Court cannot determine on a classwide basis : (1) whether nicotine is an addictive substance; and (2) which brands of cigarettes contain sufficient nicotine to cause addiction. (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, do you contend that this Court cannot determine on a classwide basis: (1) whether nicotine is an addictive substance; CLUTOI Doc: 2M9o i 31
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1 ., lieve that nothing less should be considered for sworn testimony, and that providing testimony out- side one's realm of expertise raises ethical questions. Malpractice suits are not the ap- propriate way ot= changing social policy. Few clinicians would agree with the expert in case 5, who testified that an established stan- dard of care in cases of missed appointments includes a home visit by three mental health workers and police involvement. Nothing in case 5 suggested that such action would have been anything other than an infringement on the pa- tient's rights. The patient was un- der no legal obligation to keep his appointments, and few, if any, public treatment facilities have the resources to pursue patients with more than a phone call when they miss routine appointments. It seems that this expert's opinion of what the acceptable standard of care should be was taken as a state- ment of the acceptable standard. The legal system could also be reformed. Mills (36) believes that courts should not create broad li- ability, and we agree. The tradi- tional negligence standard of cul- pability only for what was a reason- ably foreseeable consequence of one's conduct went largely by the wayside in the five cases. It has been suggested that the Supreme Court's ruling in Yoangberg v. Ro- stuo (37) provides a useful bench- mark for the duty owed to patients (4)-that is, professional judgment is presumptively valid unless it is a "substantial departure" from gen- erally accepted standards. This cri- terion is appealing but would not have influenced the outcome in several of the five cases because of the court rulings negating psychiat- ric decisions as not based on pro- fessional judgment. By this same analysis, raising the standard to grau negligence would have had no effect on the case results. Ironically courts have not looked to the professional prac- tices of psychiatry to establish rea- sonableness (34). In making this observation, Appelbaum has sug- gested that given the limits of our 730 abilities to predict behavior and the absence of any consensus on how to make predictions, the Tar- aioff standard of "reasonably should have known" may be too stringent. Elsewhere he recom- mends that the threshold criterion be some act or threat by the pa- tient, after which clinicians would be obligated to collect information on the likelihood of a dangerous act occurring or being repeated (38). A medical determination should shen be made without "reckless disregard" of the evi- dence. We think that it must be clear that psychiatrists ignored evi- dence of commitability before they can be held liable for the acts of outpatients. If society wishes, through legis- lative rather than judicial action, to provide a form of no-fault insur- ance for "victims" of psychiatric patients (as is increasingly the case for crime victims), they can accom- plish it through the usual political process. Should such a course be found desirable, we recommend that its cost not be paid from mal- practice premiums, since malprac- tice requires a finding of fault. Bad results will always occur de- spite the very best efforts. Failure of clairvoyance, without more, is not something for which psychia- trists may reasonably be held ac- countable. The patients involved in these cases were chronically and unpredictably at risk for dangerous behaviors, and the control over them imputed to psychiatrists will exist, if at all, only with the unde- sirable option of reinstitutionaliza- tion (39). References 1. TansoB v Regents of the University of California et al, 131 Cal Rptr 14. 17 Cal3d 425, 551 P2d 334 (1976) 2. Beck JC: 'Ate Potentially Violent P.- tient and the TarawB Decision in Psy- chiatric Practice. Washiogtoa, DC, American Psychiatric Ptesa, 1983 3. Beck JC: The psychotherapist and the violent paaenr: recent ase la.r, in The Potentially Violent Patient and the Tarasoff Decision in Psychiatric Prac- tice. Edited by Beck JC. Washington, DC, American Psychiatric Preas, 1985 4. MiUs MJ: The so-called duty to wara: the psychotherapeuac duty to protect third parties from patients' violent acts. Behavioral Sciences and the 14, 2:237-257, 1984 5. Appelbaum PS: The expansion of li- abiliry for puients' violent acts. Hospi. tal and Community Psychiatry 35:13- 14, 1984 6. Furrow BR: Malpractice in Psycho- therapy. Lexington, Mass, Lexington Books. 1980 7. Schwartz HI: Perspectives on psychiat- ric malpractice. Contemporary Psychi- ury 2:108-I10, 1983 8. Petrila J: Tarasoff and its progeny: du- ties imposed on mental health profes- siottals. Presented at a conference on Mental Health Legal Advocacy: Cur- rent Issues in Law and Psychiatry, New York, May 30, 1985 9. Bell v New York City Health and Hospitals Corporation, 90 AD2d 270, 456 NYS2d 787 (1982) 10. McDonald v State of New York, No 62996, Court of Claims, Albany, NY, Mar 1, 1983 11. Clark v State of New York, 99 AD2d 616.472 NYS2d 170 (1984) 12. Schrempf v State of Nea York, No 66390, Court of Claims, Albany, NY, May 3, 1984, a9'd 107 AD2d 1042, 486 NYS2nd 1010, redd 66 NY2d 289, 496 NYS2d 973, 487 NE2d 883 (1985) 13. Desaussure v Stue of New York. No 65310, Court of Claims, Albany, NY, Jan 24, 1985 Pepper B, Kirshner MC, Rygle.vica H: The young adult chronic patient: over- view of a population. Hospital and Community Psychiatry 32:463-469, 1981 14. 15. Schwartz SR, Gold6nget SM: The new chronic patienr. clinical characteristics of an emerging subgroup. Hospital and Community Psychiatry 32:470-474, 1981 16. Caton CLM: The new chronic patient and the system of community care. Hospital and Community Psychiatry 32:475-478, 1981 17. Bachrsch Il Young adult chronic pa- tients: an analytical review of the Gtera- ture. Hospital and Community Psychi- atry 33:189-197, 1982 18. Sheets JL, Prevost JA, Reihman J: Young adult chronic patients: three hypothesised subgtoups. Hospital and Community Psychiatry 33:197-203. 1982 19. Lamb HR: Young adult chronic pa- tients: the new drifters. Hospital and Community Psychiatry 33:465-i68, 1982 20. Rachlin S: The in8uetxe of law on deinstituaonalizatioo. New Directions for Mental Health Seevices, no 17:41- 54, 1983 21. Schwara HI, Appelbaum PS, Kaplan RD: Clinical judgments in the decision to coaamit. Archives of General Psy- chiatry 41:811-815, 1984 22. Rossi AM, Jacobs M. Monteleone M. et al: Vioknt or feat-inducing behavior July 1986 Vol. 37 Na 7 Hospital and Community Psychiatry
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INTERROGATORY NO. 56: Identify and describe all statements (in terms of speaker, audience, date and specific subject matter) regarding the addictive and/or habit forming properties of nicotine made by the persons indicated in your answer to the previous interrogatory. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 55 as if fully set forth herein. INTERROGATORY NO. 57: Identify all minutes and/or notes of meetings of the Board of directors and of any other meetings of officers and/or directors that discussed the issue of nicotine and addiction (regardless of the definition of "addiction" used by the speakers) and/or nicotine and habit. ~ - .RESPONSE: Reynolds'objects to this interrogatory on the ground that it seeks informatipn that is irrelAvant to issue$ of class certification. Such corporate minutes or notes, if relevant at all, could relate only to the merits, or lack of merit, of plaintiffs' claims, not class certification. Reynolds further objects to this interrogatory on the ground that it is unduly burdensome. INTERROGATORY NO. 58: (a) Using the definition of "addiction" used by plaintiffs herein, identify all documents in your possession which support the position that nicotine is not an addictive substance. (b) Using the definitions of "addictive" and/or "addiction" used in the 1988 Surgeon General's Report, identify all documents in your possession which support the position that nicotine is not an addictive substance. (c) Using the definition of "addiction" and/or "addictive" used in DSM IV, identify all documents in your possession which support the position that nicotine is not an addictive substance. (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, identify cLumI Doc: zsqt9o i 4 2
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(b) ways in which nicotine levels in cigarettes could be controlled; or (c) ways in which smokers would have a stronger, longer or more intense reaction..to a given amount of nicotine in cigarettes. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the grounds that it is overbroad and unduly burdensome. Subject to and without waiving its objections, Reynolds states that documents relating to the subject matter of this interrogatory were produced in response to discovery propounded upon Reynolds in Castano. These documents are available to plaintiffs' counsel for use in this case pursuant to the Castano protective order. INTERROGATORY NO. 52: Describe in detail (including all relevant dates, places, person(s) in charge, initial hypotheses, and conclusions) all research activities that you funded or participated in, in whole or in part, that related in any way to: (a) the habit forming and/or addictive properties of nicotine; (b) ways in which the levels of nicotine in cigarettes could be controlled; or (c) ways in which nicotine yields in tobacco plants could be increased through the use of genetic engineering. RESPONSE: Reynolds incorporates its objections and responses to Interrogatory No. 51 as if fully set forth herein. INTERROGATORY NO. 53: Identify any research projects (whether conducted in the United States or abroad) related to nicotine CcuTOI Doc: 239290 1 3 9
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RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 64 as if fully set forth herein. INTERROGATORY NO. 67: Identify all communications (whether oral or in writing) between CTR and TI and/or between CTR and any cigarette manufacturer regarding the issue of nicotine and addiction or nicotine and habit. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 64 as if fully set forth herein. . INTERROGATORY NO. 68: Identify all sources and amounts of CTR's funding for .each.year since 1980. - RESPONSE: Reynolds• incorporates its response including objections, to Interrogatory tory No. 64 as Af fully set forth herein. INTERROGATORY NO. 69:- Identify all communications (whether oral or in writing) between TI and CTR; between TI and any cigarette manufacturer regarding the issue of nicotine and addiction or nicotine and habit; and/or between CTR and any cigarette manufacturer regarding the issue of nicotine and addiction or nicotine and habit. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this ' interrogatory on the ground that it is redundant, in part, with Interrogatory No. 67. Accordingly, Reynolds incorporates its response, including its objections, to that interrogatory as if fully set forth herein. Reynolds further objects to this interrogatory on the ground that it specifically seeks information from CTR and TI, other defendants in this action. The interrogatory is, therefore, misdirected, oppressive and harassing. CLuto1 Doc: 2M90 i 4 6
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INTERROGATORY NO. 72: Did B.A.T., Ind. ever supply funding to CTR or the Tobacco Institute? If yes, describe in detail the date, amount, and purpose of such funding. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks.information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the ground that it specifically seeks information from CTR and.TI, other defendants in this action and/or from another entity who, although is not a party in this action, is a.party to a similar action brought by plaintiffs' counsel and who furthermore has been served with identical discovery requests. Thf interrogatory i%s, tKerefore, misdirected, oppressive and harassing. INTERROGATORY NO. 73: Did B.A.T., Ind. ever communicate with CTR: (a) with respect to nicotine and habit or nicotine and addiction; (b) on any other topic related to tobacco? If the answer is "yes" to either part of this Interrogatory, describe in detail the communication, including the persons,'the date, and the specific topic. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 72 as if fully set forth herein. INTERROGATORY NO. 74: Did B.A.T., Ind. ever communicate with TI (a) with respect to nicotine and habit or nicotine addiction; and (b) on any other topic related to tobacco? If the answer is yes to either part of this Interrogatory, describe in detail the communication, including the persons, the date, and the specific topic. CWT01 Doc: ?.99290 1 4 8
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w~..?G.~....fs --7 /3 ,~ - C<%~ /.-'/_ ~ ~'=~ - - ---- - `~l(y 5~u~ _ ~nA _ _. ~-- ----- ~~~.. T `f y 41", I " S 000607 ~ PLAINi1FPS OE10SiT10N EXNI/R ~
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RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. INTERROGATORY NO. 63: If you, now or in the past, has (sic) a group health insurance policy that discusses "drug addiction" or "drug dependence," how are those terms defined in that policy? RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. INTERROGATORY NO. 64: As to defendant Council for Tobacco Research, identify all requests for funding of research related to nicotine and addiction and/or nicotine and habit that was granted, in whole or in part, by CTR. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the ground that it specifically seeks information from CTR, another defendant in this action. The interrogatory is, therefore, misdirected, oppressive and harassing. INTERROGATORY NO. 65: As to defendant Council for Tobacco Research, identify all requests for funding of research related to nicotine and addiction and/or nicotine and habit that were denied by CTR. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 64 as if fully set forth herein. INTERROGATORY NO. 66: As to Council for Tobacco Research, identify all research projects in which CTR was in any way involved, that concerned the issue of nicotine and addiction or nicotine and habit. CLLITOI Doc: 239290 t 4 5
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RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to issues of class certification. Reynolds further objects to this interrogatory on the grounds th.at_.it is overbroad and fails to state with reasonable particularity the information sought. INTERROGATORY NO. 50: (a) Using the definition of "addiction" used by plaintiffs herein, for each year from 1980 to the present, identify those*brands of your cigarettes that are capable of causing nicotine addiction in smokers who smoke at least 16 cigarettes per dayr. - (b) Using the definitions of "addictive" and/or "addiction" used in the 1,988 Surgeon Genez%l's Report, .for each year from 1980 to the present, identify those brands of your cigarettes that are capable of causing nicotine addiction in smokers who smoke at least 16 cigarettes per day. (c) Using the definitions of "addiction" and/or "addictive" used in DSM IV, for each year from 1980 to the present, identify those brands of your cigarettes that are capable of causing nicotine addiction in smoker$ who smoke at least 16 cigarettes per day. (d) Using the definitions of "addiction" and/or "addictive" used in the affidavit of Dr. Harold Schwartz, for qach year from 1980 to the present, identify those brands of your cigarettes that are capable of causing nicotine addiction in smokers who smoke at least 16 cigarettes per day. RESPONSE: Reynolds incorporates its objections and response to Interrogatory No. 35 as if fully set forth herein. INTERROGATORY NO. 51: Identify by name, job title, and current address all researchers whom you funded in whole or in part (on a contract basis, on a grant basis, or as any employee; in the United States or in another country) to do any research related to (a) the habit forming and/or addictive properties of nicotine; CuaTOt Doe: 2392901 3 8
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RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 72 as if fully set forth herein. INTERROGATORY NO. 75: Identify the person(s) with the greatest knowledge of the_._corporate relationship between American Tobacco and American Brands and with respect to nicotine related research conducted and or funded, in whole or in part, by American Brands. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 71 as if fully set forth herein. INTERROGATORY NO. 76: Did American Brands ever supply funding to CTR or TI. If the answer is "yes," describe in detail the date, amount, and purpose of such funding. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 72 as if fully set forth herein. INTERROGATORY NO. 77: Did American Brands ever communicate with CTR (a) with respect to nicotine and habit or nicotine and addiction; (b) on any other topic related to tobacco? If the answer is "yes" to either part of this Interrogatory, describe in detail the communication, including the persons, the date, and the specific topic. RESPONSE: Reynolds incorporates its response, including objections, to Interrogatory No. 72 as if fully set forth herein. Dated: New York, New York February 18, 1997 JONES, DAY, REAVIS & POGUE North Point 901 Lakeside Avenue Cleveland, Ohio 44114 Hugh R. Whiting Mark A. Belasic Elizabeth A. Grove (216) 586-3939 Cwrol Doc:2s929o_1 49
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STATEMENT OF INTENT This cuideline is not intended to be construed or to serve as a:tsndard ot medical care. Standards ot medical care are determined on the hasis ut all clinical data available tor an individual case and are subject to changr a. scientific knowledge and technology advance and patterns evolve. Thr.r parameters of practice should hr considered guidelines only. AJhrrrn:r to them will not ensure a successful outcome in every case. nor .hould the%- be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultim itc judgment regarding a particular clinical procedure or treatment plan must he made by the psychiatrist on the basis of the clinical data presented h% • the patient and the diagnostic and treatment options available in the par- ticular clinical setting. This practice guideline has been developed by psychiatrists who arr in active clinical practice. In zddition, some contributors are primarily in- volved in research or other academic endeavurs. lt is possible that through such activities some contributors have received income related to treat- ments discussed in this guideline. A number of mechanisms are in place to minimize the potential tor producing biased recommendations due to conflicts of interest. The guideline has been extensively reviewed hy mrm- bers of APA as well as hv representatives from related fields. Contributors and reviewers have all heen asked to base their recommrndatioms on an objective evaluation of the available evidence. An.• contributor or re- viewer who has a potential conflict of interest that may bias (or appear to bias) his or her work has been asked to nutith• the APA Office of Research. This potential bias is then discussed with the work group chair and the chair of the Steering Committee on Practice Guidelines. Further action depends on the assessment of the potential bias. This practice guideline was approved in July 1996 and was published in October 1996.
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0 0 • kMfm QQ4SITa ml/R s to ~ II: AN/IFIZI(;A N ,JOUIZNAI. OF PSYCI IIA , I, IZY \1I11,1" I I11 \Illt l 1, .111 •\ k ( ),It I I'~ I 1996 1 1. 1[ I I t, i~- I, I[ 1( )I 1 ~'l•l~ ll~~ (~II~~II'Illll Il)I (Ill' I Il~.l[Illl'ilt c~t I',lti~ llt~ ~~ 1(~1 ~Il~~[Illl~~l~~III~IIIi~I' EXHIBIT tt _~, q7 <„1- OIII. I.II i,M[ I1.II ,~I [li,, .\illt, l I,- lil 1'.\ . Ili.llI I. \,'~ ( ) .I.tli( ) ll 0
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INTERROGATORY NO. 70: Describe all TI communications relating to nicotine and addiction (however "addiction" is defined); nicotine and habit or nicotine and health between TI representatives and: (a) government entities (including legislative and executive branches) (b) educational groups (c) health related groups (d) the general public RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the ground that it specifically seeks information from TI, another defendant in this action. The interrogatory is, therefore, misdirected, oppressive and harassing. INTERROGATORY NO. 71: Identify the persons(s) with the greatest knowledge of (a) the corporate relationship between B.A.T., Ind. and Brown & Williamson and (b) with respect to nicotine related research conducted and or funded, in whole or in part, by B.A.T., including whether B.A.T. ever shared research results with Brown & Williamson and/or other cigarette manufacturers. RESPONSE: Reynolds objects to this interrogatory on the ground that it seeks information that is irrelevant to the issue of class certification. Reynolds further objects to this interrogatory on the ground that it specifically seeks information from other entities who, although are not parties in this action, are parties to a similar action brought by plaintiffs' counsel and who furthermore have been served with identical discovery requests. The interrogatory is, therefore, misdirected, oppressive and harassing. cuUTOt Doc: 239290 1 47
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.; / 0(13 f g (- /h,t,n _ttL_ ,~7 tli~' ; c y- G_w~ - - ~ ~ /~ - --- - - ( - ---'tr.~=~d~.dk-~~daf,S-~ atc.~- -- -3_ -- - - .-..-127`~~-Ao~~ 1A t -<y1.f? A" _.- dl* s~b•m r ~. f Z ~vu4j ddAf µ- CuL'~a~ ~ ~CM. N c«ttr.i. nt,~ (Yu,~ a''`'u v IfGVlts,J - A'A - I r r r q ~ S i _ . Z Lrr[~ .~ls~ff6 r~( . S 000608
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t /::1a•: Ms. Marvin R. Martin, being duly sworn, deposes and states that he is Vice President of Information Resources for R.J. Reynolds Tobacco Company ("Reynolds"), that he signs the foregoing R. J. Reynolds Tobacco Company's Response To Plaintiffs' Interrogatories Related to Class Certification and Motions to Dismiss on behalf of Reynolds and is duly authorized to do so, that he has read the foregoing interrogatories and responses thereto and knows the contents thereof, that the matters stated in such responses are not within his personal knowledge, and that there is no individual employee of Reynolds who has personal knowledge of all such matters. These responses were prepared with the assistance of employees of and counsel for Reynolds upon which he has relied, and the responses, subject to inadvertent and undisoomred error, are based upon and necessarily limited by the records and information still in existencx, presently recollected and thus far discovered in the course of preparation of such responses. The affiant further states that Reynolds reserves the right to make any changes in the responses if it appears at any time that omissions or errors have been made therein or that more accurate information is available, and that subjoct to the limitations set forth herein, such responses are true to the best of his lmowledge, information and belief. I declare under the penalty of perjnry that the foregoing is true and oomecx. Executed on: l 7 A-? VeU My commission expires: ~~~ 0 MARVIN R MARTIN
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American Psvchiatric Association Practice Grridelilte: Practice Guideline for the Treatment of Patients With Nicotine Dependence WORK GROUP ON NICOTINE DEPENDENCE John R. HuFhes. \l.D.. Chair Susan Fiester. M.D. Michael Goldstein. \ t.D. :11 ichael Resnick. M.D. \i:holas Rowk. M.D. Douclas Ziedamn.. M.[). STEERING CO.\1.\11TTEE ON PRACTICE GUIDELINES John S. \lclnr.•re. M.D.. Chair Sara C. Charles. M.D.. Vi.e•Chair Deborah A. Zarin. M.D.. Dirm-tor. Practice Guideline Pngram Harold Alan Pin.ua. \l.D.. Direcior. Offi.e uf Research Kenneth Z. Ahshuler. M.D. William H. A.•res. \1.D. Thomas Bittker. M.D. Barton Blinder. M.D. Paula J. Clayton. \1.D. Ian Cook. M.D. Leah Dickstein. At.D. Helen Egger. M.D. Gerald Flamm. \t.l). Steven Jaffe. M.D. Sheldon X1ii'ler. M.D. Louis Alan Mtxnch. \1.1). Roger Peele. \ l.D. Bruce Pharssis. AI.D. Joel Yager. M.D. CONSULTANTS AND LIAISONS Grayson Norquisr. M.D. (Consultant) Richard Kent Harding. M.D. (Consultant) Justine Kent. M.D. (Liaison) John Oldham, M.D. (Liaison) Marcia Goin. M.D. (Liaison) Maria Lymberis, M.D. (Liaison) Marion Goldstein. M.D. (Consultant) Laurie Flynn. M.A. lLiaisonl Alfred Herzog..`LD. (Area II James NininRer. M.D. (Area 111 John Urbaitis. M.D. (Area IIII Philip Margolis. M.D. (Area IV) Allen Kavser. M.D. (Area VI Lawrence Lurie. M.D. (Area V/I R. Dale Walker. M.D. (Area Vlll Leslie Seig/e. Project Manager Developed under the auspices of the SteerinR Committee on Practice Guidelines. Successive drshs reviewed by APA comf+onents and memhersm as well as other interested individuals and orp nizatsons isee section V111 and two members of the editorial board of Tfu American luurnal of Psvchrorn•. Approved bv the APA Board of Trustees in Jul. 1996 and published in October 1996. Received by The Amencan Jannal of Pavcbiarrv Feb. 14. 1996; revision received July 11. 1996c accepted lul. 18. 1996. Copies of the Practice Guideline for the Treatment of Patients With Nicotine Dependence /ISBN 0-89042-308-31 are available trom American Psv.hiatrrc Press. Inc.. 1400 K Street. N.W., Washineton DC 20003: telephone 1-800-368-ST771order number 2308. 522.501. Cop,vri8ht 0 1996 American Ps,vchiatnc Association.
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Practice Guideline for the Treatment of Patients With Nicotine Dependence American Psychiatric Association i. I\TRODUCTTON This practice guideline provides guidance on the care of patients with nicotine dependence. Cigarette use is the most common cause of nicotine dependence. and almost all of the data available are derived from studies of cigarette users: thus, this document will focus on cigarette smoking. The recommendations in the guide- line generally apply to all smokers even though not all smokers meet DSM-IV criteria for nicotine dependence (1). This is because most of the principles for treating nicotine dependence apply to non-nicotine-dependent smokers as well. Many smokers have comorbid psychi- attic conditions (2), which are not described in this guideline; thus. the psychiatrist caring for a patient who smokes should consider, but not be limited to, the treat- ments recommended in this practice guideline. This guideline is intended for psychiatrists. However, the data summarized in this guideline should be useful to 211 clinicians caring for nicotine-dependent patients. This guideline focuses on three groups of smokers likely to be seen by psychiatrists Itable 11. Concurrent with the development of the present guideline, the Agency for Health Care Policy Research (AHCPR) developed its Clinical Practict Gwideli„e on Smoking Cessation (3). The AHCPR guideline focuses on primary care providers but also includes recommen- dations for smoking cessation specialists and health care administrators. The present guideline builds up- on the AHCPR guideline by focusing on specific pop- ulations (table 1) not covered in the AHCPR guide- lines. In addition, the APA guideline complements the AHCPR guideline in providing detail on the more in- tensive therapies. Psychiatrists interested in providing smoking cessation treatmena should be familiar with ihe AHCPR guidelina (3). - -- - - This practice guideline is limited to recommenda- tions for tratment. Actions to change public policy to- ward tobacco are very important to decreasing the preva- lence of smoking and psychiatrists are strongly urged to support such actions. APA's Position Statement on Nicotine Dependence (4) lists the more important ac- tions needed. These include•- a) encouraging appropri- ate diagnosis and treatment of nicotine dependence as a comorbid condition with other psychiatric disorders; b) increasing state and federal taxes on tobacco prod- ucts and applying the proceeds of such taxes to the pre- vention, treaanent, and research of nicotine dependence; c) changing the warning labels on tobacco products to TABLE 1. Tarpt Populatrons 1. Patrents who smokr an.t arc hrrnc •ccrr m .r :or .: pscchrattr: JrwrJer uther than nr.otm: arrcn%jrn.. .. a,thdrawal 2. Smoken who hase tadeJ meaal rrcatmcnr, ror .nro.m: cessatron and need moxe rntcn.nr tre.rrn+cnt rhat ..miJ h pros•rdeJ M• a psr:hramv i. Psv:hratrr: patrents w•ho smuke anJ .ur rcmrsr.rrd% ..,nnnc.i to smoke•trec rnpatrent waros. re•rJrnnal r.r,r6ac.. vr.. include the high likelihood of developing dependence on nicotine: and d) advocating for health insuran:e ca% - erage of treatment of nicotine dependence by yualiticJ health professionals. Prevention and treatment of smoking in young per- sons are also very important. This guideline focuses on adults. Modifications for treating adolescents are briefl.• discussed in section V.C.2. Ps>•chiatrists are re- ferred to Pree-enting Tobacco Use .~»,ong Ywt,rg Peo- ple: A Report of thc Surgeon Gc)rcrJ! (5) for more in- formation on preventing and treating adolescent smoking. ii. DEVELOPMENT PROCESS This practice guideline was developed under the aus- pices of the Steering Committee on Practice Guidelines. The process is detailed in a document available from the APA Office of Research. the "APA Practice Guideline Development Process." he.• features of the process in- cluded: • initial drafting by a work group that included psy- chiatrists with clinical and research expertise in nicotine depende-nce; - • a comprehensive literature review (description fol- lows); • the production of multiple drafts with widespread review, in which 23 organizations and over 76 indi- viduals submitted comments (see section VIII; • approval by the APA Assembly and Board of Trustees; • planned revisions at 3- to S-year intervals. A computerized search of the relevant literature from MEDUNE and PsycL1T databases for all years available (i.e., 1966-1995 and 1974-1995. respec- tively) was conducted using the terms "cigarettes," "nicotine," "smoking," and "tobacco." No exclusion criteria were used. This search produced 67S relevant Ant J Psychiatry 153:10, October 1996 Supplement 1
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'tCOT1NE DEPENDENCE treatment articles. Other databases searched were the Center r<rr Disease Control and Prevenrcon's Brhir,oti- rJphy „rr Snrul;rrt; aud Hc11th 161. the O%tord Col- laborative Trials Rectstry 1-j. and the hrhliocraphv or the AHCPR Clurrcl/ Pr,tctrcc Gurdclrrrc on Srnui;ru; Cessatruwr (3i. In addition, references in empirical arrr- cles and narrative and meta-analvttc reviews were used to locate articles. For hrevrtv. meta-analyses and reviews or treatments for smoking are usually cited in the guideline instead or ongtnal studies. However, the conclusions or the work group are based on knowledge of the individual studies included in these meca-anal.•ses and reviews and on other pertinent studies. iii. EVIDENCE RATINGS Each recommendation in the guideline receives one of three categories of endorsement using a bracketed Ro- m.tn numeral rcrllowin, the •c.ttc•rtrc•n: Tn, eorto are based on the .:rrnnr~; hrer.rcur. .in,: ,,r cal expertise and reprornt %ar% rnc ic•%ei• or rrcience in the recommendanun. Thr;r carc m: or clinical confidence are notecl: III Re~;ommenJeJ with •ui••t,intr.rl ;hni;.r, ,or.r, dence. These re:ummenJation> arc u.u,tll% or several well-:antrulleJ:lrnt;al trn.il• that ret+ortc.! •imi- lar trndrm_s or represent ke% I•nn;ir•ie• or ;hm;.u chwcn: .are wrth broad eNt+rrt ;,m•rn•cr•. JIll Recommended %rrth muclrrate• .iiiir,.rl „oiit,. dence. These reccrmmenJ,trtun..uc u•u.rlk h.r.c,l „n i few positive studies or un Ies> :~~rr~~~rrnc .lac.r cn,nr many sources. 1111) Recommended..•rth lower:lrnr:al:omtr.ie•n;< or recommended on the basis or individual :rrcum.r.tn,r•. These recommendations u.ually have ncu hren aJc- quateh• tested or have contlictinc rel+urr. ,thout ettr:a;• hut are consistent with exl+ert oprnrun and \„th n- cepted principles of treatment rir .moktnL. l. EXECiITIVE SUMMARY The following executive summary is not intended to stand by itself. The treatment of smoking cessation re- quires the consideration of many factors and cannot be adequately reviewed in a brief summary. The reader is encouraged to consult the relevant portions of the guideline when specific treatment recommendations are sought. Recommended psychiatric management stratesies that all smokers should receive are listed in tahle - tsee page 7). Table 8 lists the recommended treatments and their ratings (see page 7). There are a number of promising treatments for nico- tine dependence that may be recommended based on individual circumstances. These include intensive be- havior therapy 11111, educational/supportive groups 1II1(, exercise 11111, hypnosis 11111, anorectics (1l1(, anti- depressants (111(, buspirone 11111, higher-than-normal dose transdermal nicotine Illl(, meamylamine (I11(, nicotine inhaler 11111, and sensory replacement 11111. Treatments that cannot be recommended at this time for the treatment of nicocipe dependence leither because of data indicating lack o( Ef~'racy or lack of sufficient evidence supporting efficacy) inelude: contingency con- traaing, cue exposure, hospitalization, nicotine fading, physiological feedback, relaxation, 12-step therapy, ACTH, acupuncture, anticholinergics, benzodiaze- pines, 0 blockers, glucose, homeopathics, lobeline, nal-• trexone, nutritional aids, reduction devices, silver ni- trate, sodium bicarbonate, and stimulants. Psychiatrists should assess the smoking status of all their patients on a regular basis. If the patient is a smoker, the psychiatrist discusses interest in quitting 2 and gives explicit advice to motivate the patient to stop smokinF, including a personalized reason the patient should stop II(. When possible, advice mavi come from multiple sources in addition to the psychiatrist; e.F., from other physieians, nurses, social workers. etc. I 11. Written materials may he used as well as face-uo-face interventions (Ill. Since many psychiatric patients are not ready to quit, the goal of aJvice will often hr to motivate patients to contemplate cessation by revrew- int; the benefits of quitting, discussing barriers to qurt- ting, and offering support and treatment (III1. If the pa- tient is interested in stopping smoking, a quit date should he elicited, treatment prescrihed, and follow-up arranged (Il(. The minimal initial treatment for those who wish to quit includes written materials, brief coun- seling, and a follow-up visit or call 1-3 days after the quit date (11(. If the patient has failed serious attempts without for- mal treatment, failed with nonpharmacological thera- pies, had serious withdrawal symptoms, or appears highly nicotine dependent, transdermal nicotine is rec- ommended (1(. lf the patient prefers or if ad-lib dusinl; is needed, nicotine gum can he used instead of transder- mal nicotine (1(. If used alone, nic(;tine gum is to he taken on an every-hour basis (1(. If the patient is a highly nicotine-dependent or heavy smoker, higher- dose nicotine gum should he used (I(. Nicotine gum can also be used on an ad-lib basis to supplement transder- mal nicotine therapy I111• If the patient has had trouble stopping smoking for nonwithdrawal reasons (e.g., due to skills deficits), he or she is a andidate for multicomponent behavior ther- apy (1(. The more effective components of behavior Anr J Psychiatry 153:10. October 1996 Supplement
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5 iicztnun. hi< or her znxten . det+ression. Jrr- rt,uft% :cincentrlrln_. insomnia. irritz~u- 1tn • and resrirssness could he due to or a:;- ;ravzred h% nicnrine wtthdrawal. Also. si- rnou:h uncommon, cessation appears tct hr .ihle to prectpitate a relapse or malctr depression. bipolar disorder. and alcohol! drug problems i'_. _'61. TABLE 4. OSAA.IV Diagnostic t.ntena for Nicotine wrtnorawa, C. EPIDEMIOLOGY.aND N.aTL'RAL C . HISTORI D. At present, approximately 50% of the U.S. _ adult population have never smoked. 25°n' are current smokers (48 million), and 25% Un:% u•a , r nr,,,nnr :, • .r: .:.t. .~ ,. .. ,..... „r.,..ac.t a,:rnr.^. :1 n„ur. • rrrRJrurrt.trt:•r7.lh.•r. - in\ rcn ,irrtr,wta oin;,nrr.tnn, rr•rres.nc.• - Jr.rca•cJ neart rara ~. m,rca.a•.tirt`cnrr,,r..ar~e ..r. Tne .. mprr,m, in i. nanrm h ,.tu.a ,.:n:.... . _ .... . . rmrarrmcnt in .tr.rai. ra.ur.ttr„n.t.. , ,.rnr• :r•r. ... : rr;.r. , ., ... . _ The ,ampn+ms .tre nt,r Jur ro, .r erncral.mt,ir..r. .tc.: rr. n, •: rr -;V. .r„munreJ rrr h% ant,tnrr m.•nt.tl jn.,r.rcv are ex-smokers (111. Among current smokers. most are cigarette smokers. with fes•er than S°o using cigars. pipes. or smokeless tobacco (11). The mean number ot cigarettes smoked per da}• is about 20. Between 8°o and !S°o ot smokers are occasional or light smokers 1<i cigarettes! dav) I 11). The prevalence of smoking has declined dra- maticallv in the U.S.; however. this decline has not been uniform and has abated recently t?-1. The prevalence of smoking has declined less in those who are younger, fe- male, non-Caucasian. less educated. or poor and those with psychiatric or alcohol/drug problems 1_'-1. The median age of initiation of smoking is 15 151. Psychiatric predictors of initiation of smoking include use and abuse of alcohol and other drugs. attention deficit disorders, and depressive symptoms: however, smoking precedes the normal age at onset for most psy- chiatric disorders (2). Twin studies have found that the heritability of smoking is as great as. if not greater than. that for alcoholism (28. 291. Some oi the heriwhilitm• oi smoking is shared with and some is independent of that for alcoholism (30). Within a few• years of daily smoking, most smokers begin to develop dependence (S). For example. 50% ot smokers in their twenties meet DSM criteria for de- pendence (31). Also, within a few vears of daily smok- ing, smokers note withdrawal symptoms upon cessa- tion (5). Among older adult daih• stttokers, 87% (40 million) are estimated to meet DSM-IV criteria for niecr tine dependence (32). About one-third of'adults who smoke make a serious attempt to stop smoking each year (27). Over 90% of these attempts to quit are ntade'without formal treat- ment (27). With self-quitting, 33% of smokers are ab- stinent for 2 days and 3%-S% are abstinent for 1 year, after which little relapse occurs (13, 14). Most smoken make several quit attempts, so that 50% of smokers eventually quit (27). Smokers with a past or present his- tory of anxiety, depression, or schizophrenia are less likely to stop smoking (2, 8, 33, 34). This could be due to several factors, including increased nicotine with- Am j Psychiatry 153:10, October 1996 Supplement TABLE 5. EI'leet of Abstinence From Smoking on Blood Levels of Psychiatrie Medications (8) Al+urnen:e Increaar. RLrrJ l ctrl. Clumrpramtne Ih"%cra: lt..rirt~.tm t:aurapmc I•iurina•tutmc \..rtrtrnuna Drstpramtne H.rIuKnJt'I Prt.rran-o.l DevmethclJraitepam Innpr.tmtnr Ahannenk-t Di>ea Nt,t In:rca.r KltwtJ Lr.rl. .imunpt.hnr kthanal \ltJ.rndam ChIkuJra:eliotmJe l.ttraiepam Trtr>•rdant Ette.'t oi .ihsnnen.e un RhMal Le%rl. 1, t n;lcar Alpra:ulam ('hharpromaimc OraFepam TABLE 6. Some Essmples of Nicotine Withdrawal Symptoms That Can 8e Confused With Other Psqchigtric Conditions (8) Anxiety l)a rres.Km In%:rea.eJ Rt\1 ioIeer Inwtmnu Irntahilrn• Resrlet;ane11. Wctght carn drawal or nicotine dependence, less social support, or tewer coping skills /2J. Smokers who have current alco- hol abuse/dependence problems are unlikely to stop smoking unless their alcohol problem resolves (34). Whether alcohol/drug abusers in recovery are less likely to stop smoking is unclear (34). About S0%b of adults who attempt to stop smoking will meet DSN1-IV criteria for nicotine withdrawal (17). Smokers who have withdrawal-induced depression or severe craving are less likely to successfully stop smok- ing (2. 17). In addition, fear of weight gain appears to be a major deterrent to cessation attempts, especially among women (3S). The presence of cues for smoking is thought to be crucial in producing withdrawal; thus, withdrawal during inpatient stays on smoke-free units is often not as severe as expected 116). 5
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TABLE 7. Stratestes of Psychtatnc ManaBement for Pattents Who Smoke • . A..h. tmrrt,rnz rYnJtUrr. mtrhtJllnn tu Ju1C% mrrmJtnr, hr• • Jn.1 r•arncr, rn %jurttnne EcrJhinn a rnerapeun. .tllrJn:c • \.l% nr p.incnt m rnl• • A..r,t in C,SJtrun • 'lirr.tnce ruiirrtt•ur gain, tear ot wtchdra.val, and tear of tailure 1491. As- sessment ot motn•acors and barriers appears helptul in motivarnnc patients and is recommended 111111501. Ex- acerbation of psychiatric symptoms is likely an addt- nonal harrrer tor psychiatric patients 1391. ~. Snmkurg histun• Sevenn• percent of smokers have tried to stop in the past 12.'1: thus. the lessons learned and patient percep- tions about these prior attempts need to be assessed 11111. The more important areas to be assessed include the smoker's reasons for quitting, any change in ps.•chi- acric functioning when he or she tried to stop, cause of relapse ie.g., whether the relapse was related to with- drawal symptoms or exacerbation of a psychiatric dis- orderl. how long he or she remained abstinent, whether he or she sought treatment before, adequacy of prior treatment in terms of dose and duration, compliance with treatment, whether he or she believed treatment helped, and his or her expectations about future treat- ments f 1II]. S. Psychosocial factors Since social support is a major predictor of cessation (51), the smoking status /e.g., never smoked, ex- smoker, current smoker) of others in the household and close friends should he assessed 11111. If others in the household are current smokers, their willingness to quit at the same time as the patient or not to smoke in front of the patient should be determined. Whether and how others in the household and friends have supported or undermined prior quit attempts should be assessed. 6. Patient preferences Smokers vary in their treatment preferences. Many patients have strong likes or dislikes about pharma- cotherapy, group therapy, and individual therapy. Pa- tients sometimes prefer to stop smoking on a certain date. These preferences and their basis should be elic- ited and should be considered when developing a treat- ment plan 11111. 7. Nicotine%otinine and carbon monoxide levels Nicotine and cotinine levels can be measured in blood, saliva, and urine (52). Nicotine level can reflect smoking over the last few hours; whereas the level of cotinine, a metabolite of nicotine, is sensitive to smok- TABLE 8. Recommenoet! Teeatments tor Nrcottne tkoenoence P.t:n,r..rJ i n:-arrr. \luin,rrmttirnrn R•n.rtrr.• tncr~t•t II .Ji.ril. trJmtn_ rrtJp.e ^rt \r. •rc:. _.. , tr.tr.... .. , rnnun III strmtnu•.rmtr.-. i11 RJpw .mtr.rn.i II' •elr•nrit• matrn.tr• I II n..,mn. l „ni,; n: II le tn; in the last - davs an.1 ttttrra a i+c•rtrr mra.urr rtr rr+rai daily nicotine exposure t5_' 1. \lc•.t.urrmrnt tir ;t,nnrn, level has been proposed to help gurJr nri,;trttnr rrpla,r.•- ment, hut the utility or this stratr_\- ha, nttr hern \%0I tested 1531. Carbon monoxide level i> u:u,tli, mea.urc•.f h.• breath and retleas smukrng t+nh tr% rr the• la.r rr\\ hours 1521. The mawr asset cit :arhom monrtm.ir Ir% rl is that it is easily measured and can he u.r.i to % rrtrt cessation when patients are using nicotine rrria:rmrnt I5?i. Carbon monoxide measurement can hc• used to motivate cessation or retntorce ahsnnence, but its rttr- cac.• is unclear 154). Patients usually are truthful ah<,ut their smoking status and the number of cigarettes smoked per dav ISS1. Thus, although the described measurea show promise as helpful assessments, at present they are not necessan• for evaluation uf smoking cessation. S. OteraU psyduatrtc/irctrcral rucdic.tl ct-altratru,r Psychiatric assessment in smokers places special em- phasis on screening for affective and substance use dts- urders because these disorders are prevalent among smokers and have been shown to interfere with smak- ing cessation 1l11'_. 341. Smokers should also he hrietlv screened for the signs and symptoms of most common causes of morbidity and mortality among smokers; t.e., cardiovascular disease. lung cancer, and chronic ob- structive pulmonary disease 1_'0, 211. Among smokeless tohacco, ciFar, and pipe usen, mouth and upper airwa% • cancers are the most common causes of tohacco-in- duced mortalin•, and patients should he screened for their presence 120, 211, D. PSYCHIATRIC MANAGEM ENT In this guideline, psychiatric management refers to the skills and techniques that are critical to the care of all patients with nicotine dependence (table 7), regard- less of what specific techniques are used Itable 8). These techniques are common to all smoking interventions and should he used with all smokers. Meta-analvses have found such techniques to increase quit rates hy a factor of 1.5 to 2.0 (3, 56-58). In addition to the pres- ent guideline, several other descriptive reviews of the skills and techniques critical to smoking interventions have been published (59-67). Am / Psychiatry 153:10, October 1996 Supplement 7
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.\'1COTi\-E DEPENDENCE I. Estibltshrng 1 therJpcrrtrc 1llil,rcc tiiconne dependence is a chronic relapsing disorder: e.g.. most smokers require 3-7 attempts betore they n- nallv quit tor good !27). Many patients don't realize it usuallv rakes several attempts to stop smoking. and they will need to be remoti.•ared to attempt to quit after a failure (II) (611. Because ot this. it is important to es- tablish a rherapeutic relationship such chat the patient will return to the psychiatrist for subsequent quit at- tempts. if necessary (611. Advice is best given in a noniudgmental. empathic. supportive manner (III) 139. 61). No studies have been conducted to test whether confrontational st.•les of in- ter.•ennons used in creanng other drug dependencies are useful with smoking. In patients with a present or past psychiatric disorder, it is important to convev the mes- sage that simply having a psychiatric disorder is not a reason not to make a quit attempt (II1 163. 681. 2. The treatment setting Treatment best occurs in a svstem chac encourages cessation (61). The psychiatrist should consider making his or her worksite smoke-free (61, 69). Achieving this on psychiatric inpatient units mav be especially impor- tant, as discussed later in section IV.C.3.a. 3. Initial interventions a. Increasing motivation and readiness to change. Smokers who are not ready to stop or -are ambivalent about stopping smoking are given motivational interven- tions such as personalized information and feedback on the risks of smoking that are particular to the individual patient (III) (39). If feelings of demoralization are uncov- ered, they can be addressed by informing the patient that even the most committed smokers make several quit at- tempts before they are finally successful (III]. Revisiting smoking cessation at periodic intervals, especially when smoking-related illnesses (e.g., bronchitis) or other special situations (e.g., pregnancy, child with asthma 1 occur, can sometimes motivate smokers to consider quitting (Ill. Documenting smoking status in the medical record may help to facilitate such follow-up. Smokers may express negative feelings or fears about quitting. Problem solving around these fears appears helpful (III]. Clarification and legitimation of their feel- ings and expressions of support and respect also may be helpful (III). It is useful to explore the smoker's reasons for smoking as well (IAJ. Smokers who become chroni- cally ambivalent may benefit from encouragement to take small steps toward action, such as reducing the number of cigarettes they smoke or trying to quit for just 24 hours (III). The psychiatrist supports self-effi- cacy by identifying and praising past behavioral change and encouraging the use of strategies effective in the past. Finally, and most importantly, no matter what the smoker's level of motivation, direct advice to stop smoking should be given (I1. Stratezres su:h a> rno,c mrnnwnc,' n.r.; .,. ...,.~ ized in the sw:e• ur :nan_c an,: mom%.rn, n.i. ;-.u;.. ment models. There arc oni% .1 rr%% •(u,jlc• % Vr:r, ~r.; -~- rrtt:a:v ur prmi,itn; aJc i;r rr- nio i.i:r_ based on iracei, or;htn:r -o .Although mrn%.uior.: enhan:ement therspv al+l+ear: to i%c crtear.r tur ai,omo dependence. tti zire,n% eness. %% uh m:utrne Jrprn,irn.; has not been tested. On the other hand. :irnr;.ri r.rcr-- ence indicates that the>e apprua;nes ma% br u•crul ~ 111 h. Irrrtral nrtcrt ~•r:rr~~rr ro• l+.trr.":t: :rA•. :r r: The most ~~~tdeh used inrn.ti intcr.cnn.m. trc• thc \.r- tnonal Cancer lnstrtute'• 4 A, •trare_ic• t,.i.r.1 un •niok• ers seen in general medical ccttrn_.. Thr I•no_ram on- srsts of four steps. or tcrur As tr I: •Ask- and record smoking status k:mcrrJ in .c:non: lI1.C. I. • Advise to stop: Clear direct adv rce to sto)+:musl.rn, is essential. It is best to elicit a personal reason to :aor smoking from the patient. One ot the best %.-a%-, to rlr;rt such reasons is to ask it the patient has rhuuchc .thout stopping before and wh%' he or she was rntere.teJ tn stopping on the most recent ckcauun. •Assisr the patient in addressing cessation: The ps% - chiatrist should elicit a commitment to quit. If a specific quit date is agreed upon. the psychiatrist should otter treatments at that time or immediitel.• before the quit date. If the patient is not ready to make a commitment to a quit date, the ps.•chiatrist should plan to readdress smoking at a later date, encourage the patient to recon- sider, and offer to help if the patient changes his or her mind. In addition, the psychiatrist should give written materials focused on either motivating the patient to make a quit attempt or suggesting tips on how to make the cessation attempt successful. •Arrange follow-up: If the patient is attempting smoking cessation, the psychiatrist or the psychiatrist's staff should call or see the patient 1-3 davs atter the quit date. Waiting 7-10 days after the quit date is usu- ally too long, as many patients relapse in the first few days after the quit date 113). Brief advice by the physician based on protocols simi- lar to the National Cancer Institute approach typically doubles quit rates from approximately 5% to 10% I1) l3, i6-S8, 71, 72). Advice from nonphysicians is also effective (3, 58). and advice from multiple sources is more effective (3. 58). Although not tested, brief advice is probably less successful in those psychiatric patients who have poor self-esteem and a more chaotic social, environmental, and psychologic status. Nevertheless, such brief advice from the psychiatrist and other psy- chiatric personnel (e.g., nurses, social workersl is a rec- ommended treatment because it is a base therapy upon which other therapies can be added as needed (Il. 4. Educating about nicotine dependence and its treatment Many smokers don't realize their smoking may be a form of nicotine dependence (11). Key points to convey to patients include•: a) the large majority of smokers try multiple times before they finally quit, but with persist- 8 Anr J Psychiatry 153:10. October 1996 Supplement
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\ I , \1':\f :ltnl\; l:\ l : ence halt or all smokers qurt: hr the nature rser tahle;- and duration 14 weeks or luneer, or true wrthdrascal symptums: ci nicotine withdrawal can c+r rehe%ed with nicotine replacement: and di most smokers raii eark on. hut if the smoker is able to remain abstinent tor ~ months. relapse is unlikely 11111 r61!. S. Tirrtuzg of cessation attempt The timing of the cessation attempt is based on the parrent's readiness to change isee section III.D.3.bj r and the psychiatrist's evaluation of whether the panent's psychiatric status is sufficiently stable 11111 Mi. Thus. cessation of smoking.vould likely nor be recommended when the patient is exhibiting psychiatric symptoms but could be recommended when symptoms have abated and maintenance psychotherapy or pharmacotherapy is underway JIll (68). Since smoking cessation can induce withdrawal symptoms that could interfere with psychiatric diagno- sis and treatment and since cessation can change the blood levels of several psychiatric medications itables 4 and 5) 18), it may be best to recommend cessation when no major changes in the treatment of a psychiatric dis- order are underway 11111 (68). If cessation has to be de- layed, the psychiatrist should he sure to keep cessation on the treatment goal list to address at a later time I11. On the other hand, sometimes smoking cessation may be integrated into the lifestyle changes that are a part of certain psychiatric treatment le.g.. during ces- sation of alcohol use) (see section V.A.1.). Also. admis- sion to a smoke-free inpatient unit can be used tc mo- tivate a cessation attempt. Finally, intervention is indicated if the patient has recentlv been diagnosed with a smoking-related illness, as smokers with such illnesses generally have higher success rates 1-t9, 73) (see section V.B.1. ). 6. Abrupt versus gradual cessation Most patients use and most clinicians recommend abrupt cessation of smoking rather than gradual reduc- tion (74). Gradual reduction has been thought to he less successful because patients appear to have difficulty achieving further reductions once smoking 5-10 ciga- rettes per day (S3). On the other hand, most of the sci- entific data available suggest no difference in the out- comes of abrupt versus gradual cessation (3, 33, 56. 75); thus, patient preferences to use gradual reduction should be respected 11111. However, with a gradual ap- proach, patients should be advised to set a date by which they will completely stop 11111 and not to use nicotine replacement therapy until they have stopped using cigarettes f11l. 7. Dealing with weight gain concerns One of the most common fears around smoking ces- sation is weight gain (76). On average, smokers weigh 2-3 kg less than persons who have never smoked and when thev•aol+cmr,lcrnc rnr% ---arn %.rr_n: ;:r•,;:, cI., rr. similar in werghr to thrw.c %% no n.t%Ln; %~ - .Wo,;.! . . The larce matuntv or smui.rr. _.trn %r r,cnr ,r%v- ::,. :. re%%* munth• I+crst;e»atrun. nur mam i.trcr :o•. :..., all (ir thr. arr_ht. \\~umrn %% nil .1rY 11rr.rJ% rrl;:i_ : keep %%ershr ~tr cain the mo.t r" . Even though thr health hrnrtrt. rit ~otul+l+rn; :Iearhy <wnwerCh the health rr.k, ut wrr_ht _.ur, : trar or wrrCht gain r, ,t m.uur deterrent to .nxon:rr_ sation. rsl+ecrall.• amun, \%umrn ". Ho.. r\rr. ;arn after stcrpprn= smi,t,rn; Ju- mu r,• smoktnC i I'r. In fa.t. :un:rntr.ttrJ rttortn to orrrrot weight gain h% dieting during ah.rrnrn:r ui;rr.r•c. nor decrease, relapse hack to >moktnL :'S, '4. Th i. n,.r % i•v because trying to stop smoking utd trvrng tit .irrt at the same time is just nx, difficult. Rather than .irrtrn;;. increasing physical activity upon .caaanrm. Ir.rrnrn_ health.• eating strategtes, or convincing the smo1.cr to tolerate a moderate amount ur weight gain tr.rr rhr rrr:r 3 months and to work on losing weight later un ;an hr recommended 11111 fS0t. \icuttnr gum, hut not thr nicotine patch. appears to delay weight gain and could be used to delay attempts to control weight until rrl.tp.c to smoking is less likely 11111 (81 ) S. AdrisnrR,r/xnnt alcohol and cJj)i•inc rac Alcohol use is a risk factor in most studies of smoking relapse 182); thus, either diminishing alcohol intake or abstaining from alcohol is recommended I1111• Caffeine use typically does not change with cessation 11'), and whether caffeine use is a risk factor for relapse is un- clear t831. Smoking increases the metabolism of caF- feine, and smoking cessation increases caffeine levels hy .i0 %-6O'S„ (K41. Since many of the symptoms of caf- feine intoxication and nicotine withdrawal overlap (e.g., anxiery•, insomnia, restlessness), reducing caffeine intake postcessation might be helpful; however, the one study to test this hypothesis was negative (84). In addi- tion, abruptly stopping caffeine could induce a wrth- drawal syndre)me of its own (K5). In summary, with this contradictory evidence, patient preferences on whether to change caffeine intake should be respected I 1111. 9. Folloa-up visits The first follow-up should occur within 1-3 days af- ter the quit date, as the majority of smokers relapse in the first few days 111 (13). The scheduling of further follow-ups should be determined by the patieni s per- ceived need, past history of cessation, past psychiatric history, whether he or she is taking a medication whose blood level might increase with cessation (table 5), and whether he or she is taking antismoking medi- cations that require visits to monitor side effects or plan tapering 11111. At follow-up, the psychiatrist assesses whether the patient has smoked and, if so, the number of cigarenes smoked per day (111 (61). The psychiatrist also assesses the severity of withdrawal symptoms, the onset of any A,n j Psychiatry 153:10, October 1996 Supplemern 9
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\f" 0:'1\F 1;.^F\i)~ \. F dependent smokers would most benenc from niconne gum. patch. or nasal sprav has not been tested 1 1: . Number ot cigarettes per day. presence or sr¢nrncanr withdrawal during prior quit attempts. and rrme to rrrst cigarette have also been proposed as indicators ror the use of nicotine replacement therap.-. but there are no data on the utility of these indicators. Some have sust- gested that nicotine replacemenc therapy be used only rr the patient is enrolled in behavior therapy: however. the data clearly show that nicotine replacement therapy is effective in the absence of behavior therapy isee section III.F.?.c.3 ). In summary, nicotine replacement should be con- sidered in all smokers who have seriously tried to quit on their own and failed (III). Use of nicocine replace- ment in smokers with cardiovascular disease or who are pregnant is discussed in sections V.B.2. and V.C.3.. re- spectively. Although nicotine gum and patches are available over the counter, psychiatrists still need to be involved in their use by encouraging use when appro- priate, supplementing package instructions. and provid- ing adjunctive psychiatric management and, when ap- propriate, psych,osocial and other pharmacological therapies. 2) Pretreatment evaluation. Some have suggested precessation codnine level is a useful benchmark to ex- amine the percent of nicotine replaced by nicotine medi- cation therapy and thus make decisions on whether higher doses should be used. Whether this improves treatment is controversial (53). 3) Length of treatment. Most treatment optimally lasts 4-6 weeks before capering (III). Some have advo- cated longer-term use of nicotine replacement therapy and even a nicotine maintenance program. Two pro- spective trials differed in whether longer treatment with nicotine gum produced higher abstinence rates (135. 156). A recent meta-analysis of nicotine patches did not find that longer treatment was associated with higher quit rates (133). 3. Antagonists a. Goals. The goal of antagonist therapy is to prevent cigarettes from producing positive reinforcing and sub- jective effects. b. Mecamylamine. Mecamylamine is a noncompeti- tive blocker of both central nervous system and periph- eral nicotinic receptors (124, 157, 1S8) that decreases the positive subjective effects from cigarettes 1157, 158). When mecamylamine is given to smokers who are not trying to stop smoking, they initially increase their smoking in an attempt to overcome the blockade pro- duced by mecamylamine (157, 1S8). Mecamylamine does not precipitate withdrawal in humans, perhaps be- cause it is an indirect blocker (157, 158). Early studies suggested some short-term efficacy with mecamylamine, but the high doses used produced significant dropout rates because of side effects (157, 158). Side effects included abdominal cramps, consti- pation, dry mouth, and headaches. Based on a theory that combined hio:ka.ir anJ a_ont.: rn:-.:^' henenual A ~a . a rr;tnt :rUJ% .kim.rut;,: o%% me:amriamrne .tnd nr:otrnr p.rt:n ans nrt,,;u.r.:.. _ nrir.ant rncrease in sun.-trrm rrrr;u;~ %%;;r. rr%% •...:,~ fects 1 1601. Antagonists have not been rttr,:nsr in tic+lt'l,: dependence because ot :omplian:r pruhirm• I t% I Smokers tend to be more comc+irant than ut+umJ .iru•- ers: thus. nicotine antagunv;t> mr_ht hr rrrc;ri% r h, - havroral programs to msurr:umrii.un;r •inm.rr ro cno.r used with alcohol and :o:arnr JrprnJrn;r mr_hr .ii.t, be helpful 11611. In summar%. mr,am% iamrn.• Li;i.•.ur- hcrenc evidence to be recommended but i. :un•iJcrrJ promising. c. \altrc7orre. \altrexone rs a lonx-.tarm, rurm tir the opioid antagonist naloxonr. The rationale n+r u>in; naltrexone for smoking cessation rs that the perrorm- anee-enhaneing and other positive eftrcts ui nr;umnr ma.• be opioid mediated 1lti?!. Most. hut nor all. ~.ruJ- ies have found that naltrewnr incrrasr..mokrng irnrrr- preted again as an attempt to overcome hlo;kader 1123. 163). There are no data on naltrexone as acessztion treatment nor on what happens to cigarette use in alco- holics treated with naltrexone. The few side efieccs from naltrexone include elevated liver enzymes, nausea. and blockade of analgesia from narcotic pain relievers 1123). In summary. at this time. naltrexone lacks sufti- cient evidence to be recommended. 4. Medications that make i,ctake,uversive a. Goal. Lledieations in this class produce unpleasant events when the patient ingests the medication. Disulfi- ram treatment for alcoholism (164) is the most widely known example of this class. b. Silver acetate. This medication combines with sul- fides in tobacco smoke to produce a bad caste. Silver acetate has been tested as a gum and as a pill; neither form has consistentiv been shown to be effective (3. 56. 123, 149). In faa, the FDA recentll pulled silver acetate from over-the-counter sales because of lack of efficacv (149). As with disulfiram. compliance appears to be quite poor; thus this treatment might be effective if used in conjunction with a behavioral compliance program. The major side effect of concern is argyrism (silver poi- soning), which produces discoloration of skin. This ap- pears to be very rare at the doses used for smoking ces- sation (149). In summary, silver acetate lacks sufficient evidence to be recommended. S. Medicatiorrs that mimic nicotinic effects a. Clonidine. Clonidine is a postsynaptic a: agonist that dampens sympathetic activity originating at the lo- cus ceruleus (123, 125, 165). Ic appears to have some efficacy for alcohol and opioid withdrawal and thus was tried with nicotine withdrawal as well (123. 125). Several clinical trials used oral or cransdermal clonidine in doses of 0.1-0.4 mg/day for 2-6 weeks with and without behavior therapy. Three meca-analytic reviews Am J Psychiatry 153:10, October 1996 Supplement 15
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ability to self-titrate niconne dose and to stop using it immediateh• betore intermittent smoking ie.¢.. during passesi (I111• In addition. many panents nnd rhat only a teK• pieces oi gum per day are sufficient to prevent with- drawal symptoms 169. 190). The nicotine patch has the advantage of improved compliance and stable nicotine replacement. Thi> ma% Nc•r•c::.:ii~ .r, I;:, ditterentrannz nicotine ";rh.3r.wa, :norr. ,+rn,- arn: s%mt+toms i5 . One Jr,al%.int.t_c or ni„+rtnc and patcn is tnat I+arienr, ma% >mklkc %% nri; u•+rr; 11IIi.AIthauLh not desirahir. rnrs apnean ro i•r un,lp'; to produce iizntn:.int .rJ% erw ettr;r• l ~.: . V. CU`1CAL FE.•1TURES INFLUENCING TREATME\T A. PSYCHIATRIC DISORDERS 1. Alcohol/drug usdabuse Some 15%-20% of heavy smokers have current al- cohol dependence or abuse (34). Smokers who have current alcohol/drug problems are unlikely to stop smoking permanently without overcoming the alco- hol/drug problems (34); thus, in most cases, alco- hol/drug abuse problems should be treated prior to or concurrent with the treatment of nicotine dependence (II). About 80% of alcohol/drug abusers who are in treatment are smokers (1, 34). About half of such smokers are not presently interested in stopping smok- ing (34) and thus would benefit from treatments to in- crease motivation and readiness to change (Il]. For the other half interested in stopping, whether it is best for them to stop smoking at the same time as they stop alcohol/drug use or to stop smoking immediately after or long after stopping alcohol/drug use is unclear (34). One rationale for stopping smoking at the same time as stopping alcohol/drug use is that use of each substance serves as a cue for use of the other substance; thus, by stopping both substances, such cues are eliminated. The major rationale for stopping smoking after stopping drinking/drug use is that often stopping drinking is a more urgent concern and that stopping two drug de- pendencies at the same time is just too difficult. Given the absence of empirical data, patient preferences for when to stop smoking in relation to alcohol/drug abuse treatment should be respected (III]. A common concern is that smoking cessation will cause relapse to alcohoVdrug use. Most of the available data do not support this (34). In two studies, 80%- 85% of recovering alcoholics reported no increased craving for alcohol ao~ did they relapse to alcohol use when they stopped smoking (2, 34). In fact, correla- tional studies suggest smoking cessation may decrease the probability of relapse to alcohol (34). However, fre- quent monitoring during smoking abstinence is recom- mended in this group to help prevent the other 1596- 20% from relapsing to drinking during smoking cessation (III]. Although not empirically tested, smok- en who have a history of increased desire for alcohol during abstinence from smoking could either reenter or intensify ongoing therapy for alcoholism or could be prescribed a course of disulfiram (III]. There are very little data on how to tsilar a >mokinz .e>..rnun pr,,- gram to the specinc nrrds ot re:u% ennL.rl:ohulr:.: r._.. whether such patients need a murr rnten,ivr I+ro_ram. would do better in a 12-step ur behavior cherap~ rnt- gram. or..ould need hicher-than-nurmal dose ni0mnc replacement because they are more ntcottne JerrnJrnr (34). Hoa•ever. recent srudie•.uttcest treatment or smoking may be efkctr.•e either during or atter trr.rt- ment for alcoholism 11111 (3;. 1941. 2. Depression Among patients seeking smoking cessation treat- ment. 23°o-i0 %o have a past history of nt,jor depres- sion and man.• have minor dysth.•mic symptoms 1=. 167). Since both have been shown to predict poor smoking cessation rates and since one study reported that 33 %e of those with a history of bipolar disorder and 18% of those with a history of unipolar depression relapsed to depression during smoking cessation l261, the psychiatrist should consider starting or restarting psychotherapy or pharmacotherapy for depression in patients who state that depression intensified with ces- sation or that cessation caused depression (lil1. This recommendation is based on the results of recent trials that found that cognitive behavioral therapy for depres- sion and antidepressants improved smoking cessation rates in those with a past history of depression or who had symptoms of depression (168, 180, 195). Finally, for a smoker with a past history of depression currently taking antidepressant medication, it is important to note that some antidepressant levels will increase with smoking cessation (ill (8). 3. Schizophrenia , Patients with schizophrenia who smoke are often not interested in stopping (33, 44, 196). Thus, strategies to motivate these patients to commit to quit are especially important (I11]. When patients with schizophrenia do try to stop, many are unsuccessful (33); thus, intensive treatments are appropriate even with early attempts (lII]. The high prevalence of alcohol and illicit drug abuse in patients with schizophrenia (33) can interfere with smoking cessation [Il(. The blood levels of some ancipsychotia can increase dramatically with cessation and nicotine withdrawal can mimic the akathisia, de- Arn J Psychiatry 153:10, October 1996 SupplemeW 21
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.,~.,,.. ~.,~.~. „~. .._ residential care setnn_s. Controlled studies of treatin, nicotine % ~•ithdrawai symptoms on medical or ps%-:htat- ric inpatient wards have not been puF?iishzd: thus. tne recommendations belo%% are based on treating with- drawal in outpatient secnngs i lb, 1-,. _'. Assessnrent a. WithdrJU-Jl. Assessment focuses on reports of a history of wichdrawal symptoms in prior hospitaliza- tions- withdrawal during prior voluntary quit attempts. or significant rear of withdrawal 11111. b. Smoking cessation. An iripanent stay may be an opportune time tor iniciating treatment tor nicotine de- pendence le.g.. because of intensity of exposure to medical staff. diagnosis of medical condition, removal from usual smoking cuesl. It maV therefore be helpful to include smoking cessation on the master treatment plan whenever relevant. Smokers should be assessed tor their readiness and monvation for change as described in section III.C.1. [Ij (39). Those considering quitiing should be asked about their interest in using the tempo- ran• abstinence of the smoke-free unit as the beginning of an attempt to stop smoking permanentlv 11111. 3. Psychiatric management a. System issues. It is very difficult to moti.•ate inpa- aents to stop smoking unless the unit is smoke-free (69. 190); thus, a smoke-free psychiatric unit is recom- mended [1]. Although many inpatient units have been concerned about going smoke-free, the large majorit.• have found it less difficult than anticipated 169, 190). Studies before and after institution of smoke-free units indicate no increases in aggression, disruption, dis- charges against medical advice, use of medications or restraints, or admission refusals (190). One of the most important issues is to prevent psychiatric staff who smoke from either pqrposefuUv or inadvertently under- mining smoke-free restrictions. Permitting staff to smoke while on the inpatient unit or in contact with patients may increase the difficulty for patients who are trying to quit. Giving special off-ward privileges to allow patients to smoke or labeling off-ward passes as 'smoking breaks" implicitly condones smoking (69, 190)..In addition, there are risks in allowing the patient smoking breaks; e.g., if the patient has suicidal ideation or a history of eloping .or acting out on passes (III). Policies that pro- vide breaks for both smokers and nonsmokers (on the same schedule) may be preferable to policies that pro- vide smokers with extra passes. Other recommenda- tions for implementing a smoke-free unit are discussed in recent reviews (69, 190). b. Patient education. Patients need to be educated about the rationale for a smoke-free unit; i.e., it is not to force patients to stop smoking but to prevent second- hand smoke exposure to other patients and to be con- sistent with the institution's goal to encourage healthy behaviors (11) (69, 190). Patients should also be edu- cated about the goal or rrearrnrn:: %% c,. drawal symptom% an.!- it t+atirnt> ,trc icrt, rr•tr,:. ;, 7; :7, them hcrtn a cessariun artrmr: ;II.. .\Lta% ^.mcr:;. unaware ur the %-aiid s% mc+mm, or n,,,•:nu %% and their time course: thw.. rJU:anon .tnou; :nc•, ,... he helpful Jill ira, IyU.. c. ,Ilu,utornrg. Patirnt< need to be momtorr,i : chances in ps.:hiatn: >. ml+tum.. a> %%im.ir.t.%.ti worsen anxiety. insomnia. :un.entranun. and gain and can:ause cltni.alh >i,n~ti;ant in:rca.c• in cnt levels of several psy;hiarn: mrJi:anun. 11111 lt.1hir• ; and ;i t_. Si. For twml+lr, mam al;uhoh;. !-moi.r. Thus, during alcohol detumn:atiom on t .ntoi,r-rrrr ward. how much of the rrrirahiiin , anxrrt%, tnmmim.t. restlessness, difhculm concentractnc, and drl+rrssiun i, due to alcohol versus nicotine withdrawal i: un:lear. Although nicotine withdrawal is thought to he milder. there is substantial benween-person vartahiltn such that some alcoholic smokers have nicotine wtth.lra"al symptoms that are more severe thin their alcohol %.,th- drawal symptoms (191). Similarly, when pattrnts with schizophrenia are hospitalized and given higher dr+>cs of inedications, any increases in restlessncss could hr due to nicotine withdrawal rather than neurolepnc-m- duced akathisia. Finalh•, cessation rsf smoking can cause dramatic increases in blood Ie%•els of some medi- cations; e.g.. clozapine levels can increase 40% when smokers are deprived of nicotine ( 192 1. 4. Use of psychosocial tre.tnucrtts The efficacy of psychosocial treatments for with- drawal symptoms has not been tested (16); however, the clinical experience of the Work Group on Nicotine Dependence suggests several strategies [III[. Relaxation tapes can be used to alleviate anxiety. Anger can he averted by temporarily avoiding interactions. Insomnia can be decreased by improving sleep hygiene. Weight gain can be combated by increasing activity. Distrac- tion and activities aimed at keeping busy can be used to get through craving episodes. Support groups for those going smoke-free and support from famih• and signifi- cant others for going smoke-free can be helpful as well. S. Use ojpharnracological therapies Nicotine withdrawal during hospitalization is often not as severe as anticipated because of the absence of smoking cues, the distraction of the primary problem, the effects of medications, etc. Thus, prophylactic phar- macotherapy should be considered only when patients complain of withdrawal symptoms or if withdrawal signs are observed IIl. Exceptions to this rule would be those patients who are so concerned about nicotine withdrawal that they will not accept hospitalization without treatment for withdrawal. In this scenario, given the low risk of nicotine replacement, prophylactic treatment with nicotine replacement may have advan- tages over giving extra passes for smoking breaks 11111. The advantages of nicotine gum include the patient's 20 Ant J Psychiatry l 53:10, October 1996 Supplement
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~,iCOT1NE DEPENDENCE I11. TREATMENT 1'RINCI('LE:%ANn .aLTFR\ aTl\ F, A. I\TRODI'CTIO\ There are many similarities hetween ni:orinc and other drut; dependencies (.i6. 3--. There are alit) si_- niticanr difterences. For example. although nicotine dependence produces dramati,; health problems. it usualk. does not produce sicninwnt interpersonal. th- nanual. legal. or psychological problems. Thus. the present guidelines a•ill in some respects he similar to and in others different than the .anrcrrca„ Psy.•hratrrc Association Practice Guidcli,tc /in the Trc.rtntc,rt ni Patle,tts u•ith Substance Use Disorders: .4lcahnl. Co- car,re. Opiords (38). The tollowing sections contain data regarding the likely impact ot avarieq• ot treatments tur patients who smoke. It is important to note that the hulk of these data are derived from studies of patient groups who are not under psychiatric care. tExceptions to this are noted.i Expert judgment has been used to determine the applicability of these data to the populations under con- sideration in this guideline. i. Readiness to chlrtgc sud mnrr, .rrt~ ~rr n•.1rut About 40% ot current smukera are not :om.wcnn_ stopping zmuking in tiie wrcseeanie future 4.:1. Ti,c•, patients may be uninrc,rmed. uemuraltzea ahout tner ability to change. or Jrtencice and re.ictant to .Man.• psychiatnc patients .tre prunahi% in thi• t+h.t.% (33, 441. Another 4ll°„ of ~urrenr mol:en arc am't+i%.i lent about quitting 031. These smul,rr> ha%e_i%en cc riuus thought to gtvmg up a111UA111,L' iiut arc not %cc ready to commit to quitting. About :U".. ot .urrent smokers are intending tu qutr smoking in tne next te%% months (43). !Nanv of these patients ha.c m.t,ie .i quit attempt in the past year or ha%e tal.en amall crep~; a,- ward yuittittg, such aa cuttinL Ju..•n on the numher (ir cigarettes that they smoke. Making dtsttncaon. ha.cd on readiness to change ts,mlx,rtant hecause. as outlined In section 111.D.3-, smokers who are not constdertnc quitting appear to need dtfterent treatments than those who are ambivalent alwut stopping or those presenrh• interested in stopping. B. GOALS OF TREAT\lE-\T Long-term abstinence is the ultimate goal of the treat- ment of nicotine dependence. Initial goals include mo.•- ing smokers from not contemplating smoking cessa- tion, to contemplating cessation, to initiating a quit attempt, to quitting for a short period Ill)1a91. Whether harm reduction (e.g., switching cu low nicotine ci>;a- rerttes or cutting down on the number ot cigarettes smoked) is an acceptable goal is debatable because the health benefits from these actions are not well demom- strated, compensatory behaviors occur, and patients may consider harm reduction as a'sate haven,' which will undermine later cessation attempts 1401. Whether long-term use of nicotine medication is necessary in some smokers is also debatable (411. Management at withdrawal is an important goal in and of itselt, espe- cially for those on smoke-free wards 18). Nicotine in- toxication is rare•, its treatment is not covered here, and the reader is referred to other sources (42). C. ASSESSMENT The patieni s current smoking status (e.F., current smoker, ex-smoker, never smoked, number of ciga- rettes/dayl needs to he routinely determined. The com- prehensiveness of subsequent assessment is determined by the goals and characteristics of potential interven- cions; i.e., different assessments are necessary to guide the application of brief advice, the intensive treatment of prior treatment failures, or the relief of nicotine with- drawal in an inpatient setting. _'. Dr,tiursint~ ,u«~ttnc• ~lr)~c•mlr,,, i• Quantifying a smuker'a JrLrrc of nwurmr JcpcnJ- ence is impurtant h"au.r highly nicotine-Jef+rnJrnt smokers are more likely to nerJ morr tntensivc thrr- apy. especially pharma<othrral+y ucr .rcuun III.F.i. Table 2 illustrate% the l)S.\I-I\' crttrrta tor .uh,tan~r JepenJencr, with example% of hit.%- thev apl+l- tti niti,- tinr dependence t ltli. AIrhuu4h thc I)%\I .>,arm ha. nut been turmallr rexceJ .t. a nua.urr to I;wJr thcrap~ , it does appear to hc reli.thle and to have (+ru.pecnvr validity l4:-.4'1. The Falterstrom scale asseuments (table .11, widely used in treatment studies, have proven reliability and validity 112, 48). They have been shown to predict suc- cess at stopping smoking and, more impurtantly, to predict which smokers especially benetu trum mcuune gum or nasal spray (see accciun IIl.F.2.c.). Several other markers, of nicotine dependence have been proposed; e.g., number of cigareaes/day, time to first cigarette lan item on the Fagerstrom scaleh coct- nine levels, amount of withdrawal on last anempt, and number of unsuccessful quit attempts. Huwever, with the possible exception ot time to first aRarette t4a31, these have yet to be shown to have significant treatment utility. In summan•, both the DSM-IV and Fat;erstn+m scale assessments are recommended 1111. Ln 3. Mntivators %rn a,td barriers tu quitting ~ ~ ~ m The most common reasons for trying to stop smoking --i are to improve health and in response to social pressure ~ 1491. The most common harriers are fear of weil;ht oo 6 Am f Psvchiatn• 1.S.l:lw7, October 1 yyt+ Supplente,tt
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~h t„t,r thrra~+c •\Ittst Imrt~rtantl, tor thu _ut.leiinc. rherr .trr n', •1.tta un h<s.. cmnker. ~~Ith al~unt~l/Jru~~ .thucr. an.~rtN . Jcprtsslnn. or tunrr r;c,:hlatn: JLttrdrr< choulJ hc n'.'t:heJ a0 sl+ecln; trr.ttmrnt•. E. TREATMENT OF SMOKING IN PATIENTS VV1TH .a CURRENT PSYCHIATRIC DISORDER One study has shown that bt:haviuraUcocnlttve ther- ap. tor depression is especially helptul with smokers with mild depresslve sYmptoms I I SO. 19 ' 51. Other stud- les have tested treatments for smoklnc among those with alcohol and other drug dependencies. hut none have had much success (3-I'). As described earlier, smok- ers with nonniconne psychiatriddrug disorders appear to have more difficult% • stopping smoking 12. 16Ti: thus. studies of efficacy of treatments of different content and duration in smokers with past or present histories of ~F+rah: (^•.: hi.ltrn. ::hlzut+hrc•nl.t..trc nrc.lc.:. F. TREAT\tE\T isF WITHD1: a\\ \1 t~ •\I. In: FKEE t'\IT• A> dea:rlt'eJ earflrr. >r%rr.ll -~tU.11t:• Il.l\C' (o1111.; r;Ll' smuke-rrer unlt•.[rt• not a• JI1h:UIt t.` m.llt.l„ .!• ~ rt dtaed 1 Iyt1•. Htmrver. i•c:.tu•c .mt.l.ln_ :.tuse% nt:utlnr .ttIthjra"al •%mrrt+nt, rn.ir „%.r,.tr sclth mans I+a-:hlatrl: >\mc+a,nt• ,. _. irrit.tl•tiltc. M• samM,l l. cess.tnc,n ha!, i~rrn h\r•..thcNvr.i R` iiurrrcrrt with ps.•chtarn. Jta-pua,t. tt, c<or.rn rcrr.ti p..,iti.tt• nc disorders. tu:ausr relal+•r in unic• patlrnr, in rrml•- sion. to mimic or worsen side rrrea, rrum .r% cr.ti mu,il- catlOns, and to suhstantlally tn:rea.r hluttJ Ic•tc•I• iit several medicationc t_. 81. Whrther thr.r rttc;t• trr clinicall%• significant needs to hr :tuJlrJ. VII. INDIVIDUALS AND ORGANIZATIONS THAT SUBMITTED C:OM\IE\TS We thank Barbara Lascelles for her excellent secretarial help with the mul• tiple drafts of this document. Dave Abrams. M.D. Andrew Baillie. Ph.D. Tim Baker. M.D. Richard Balon. .%1.D. Thomas Binker. M.D. C.H. Blackron. M.D. John Blamphin Sheila Blume. M.D. Ralph Bohm. M.D. David W. Brook. M.D. Sara Charles. M.D. George J. Cohen. M.D. Sheldon Cohen. M.D. Dave M. Davis. M.D. Praksash N. Desai. M.D. Leah Dickstein. M.D. Karl Olov Falterstrom. M.D. Michael Fiore, M.D.. M.P.H. Saul Forman, M.D. Tom Glynn. Ph.D. Larry S. Goldman, M.D. Marion Goldstein. M.D. John Grabowski, Ph.D. Sheila Hatter Grav. M.D. Donna Grossman. J.D.. \1.P.H. Harry A. Guess. M.D.. Ph.D. Frederick G. Guggenheim. M.D. Joseph Hagan. M.D. Dorothv Hatsukaml. \I.D. Al Herzoe..M.D. Richard B. Heyman. M.D. Richard Hurt. M.D. C.urlnne G. Husten. M.D.. .M.P.H. .\IaRln Jarv9s..M.D. Elaine \t. Johnsen. Ph.D. \alini 1'. Juthant. \l.D. Lori Karan. \1.D. Robert Kimmtch. M.D. .Martha i:irkpatnck..M.D. Thomas i:ittke. M.D. Ham Lando. Ph.D. Alan I. Leshner. Ph.D. Edward Lichtenstein. Ph.D. Velandv Manohar. .\1.D. Ronald \tartin. M.D. Tom 1.1cCl•ellan. M.D. Roy MentnnRer. M.D. Michael Mkven. M.D. Jane Moore Jerome NIono.M.D. RtxlriCo Munai. M.1). Jim \inutcer. MLI). Claire Palmer Christi Patten. Ph.D. Rtnter Peele. \1.D. Herbert S. Prc.rr..\t.I). P a u l I' i l k un ta. I'h. l). R<ihert F. I'rtrn. Ph.h. Ghulam `adtr. \1.1). \'au}thn I. Rickert. l'cv.D. JrJ E. Rose. Ph.D. Pedro Ruiz. M.U. Mitchrll L Schan. Ph.D. Charles tichustrr. Ph.D. Paul M. kh.rc. M.D. Saul Shrttman. I'h.D. C:hn. Silagy. \1.1). .luhn Slade. \I.1). \ada titutland. \I.n. William R. Tatumcr. \I.D. Ruhen Trachti;rthcryr:. J.D. C:arol \tartinez Weher. M.D. .hneph Westernteyer. \1.D.. Ph.D. Duuglas M.(.. Wiltotl. M.D. Steven H. Wt«df. M.D.. M.P.H. Valcrv W. Yandow. M.D. Am J Psychiatry 153:10, October 1996 Supplement 25
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N1CC1Ti\E DEPENDENC:E developed I S-. l 0a ,. %lust selt-heil+ materials arc i•~c- ha\lorali\ (irrenred. \\'hether icit-help Inrervcnnon• used cc•Ithcrur additional :cmtact or support In:reasc smoklng, cessation Ii, deharahle - 14. .5-. "1. -_. -4. N. 9_':. Rcactrve telephrme :uunselln;: via a hot-Ilnc an- pears to increase .essatfun when added ru uther help interventions 1 lt)-s-Il)6r. and meta-anal.•ses sug- gest a small positive effect 13, Selt•help materlais appear to he more etrectrVe in. patients who are less nicotine-dependent r 10-. 108 1 and more mutrvated (S-). Use ot multlple modes or therzpy re._.. wrrtten materials plus phctne contactl appears to enhance the etfecnveness of self-help 158. S'. 1041. Tailoring mate- nals to the specific needs and concerns of each patient also appears helptul t70. 1081. In summar.. self-help materials are recommended as part of a behavioral therapy package 1111. 3. Educationll arrd arrppurtuvc groups The goals of educational and supportive e;roups are to teach patients the harms of smoking and henetrts of cessation and to provide group reintorcement tor not smoking. The efficacy of education and group suppurt in themselves ti.e., without the behavioral techniques listed ahovei is debatable (3. '1, -2. 109). On the other hand, the clinical experience of the Work Group on Nicotine Dependence and other clinicians is that group suppart is important fur some patients; thus. educa- tional and supportive groups are considered a promis- ing therapy 11111. 4. Hrpnusis The usual goal of hypnotherapy for smoking cessa- tion is to implant nonconscious suggestiuns that will deter smuking; e.g.. smoking will he unpleasant. Three meta-analvses reported hypnosis was efficacious 156, 57, 92); however, the most recent meta-anal.•sis did not (3). In addition, several quantitative reviews concluded the efficacy of hypnosis was unproven 1.5 1. 62. 'at. Much of this discordance is because most hypnosis tri, als have poor methodologies and were excluded from consideration in some meta-analyses or reviews. Given ihe conflicting evidence, hypnosis is rated as a promis- ing treatment 11111. S. Other therapies The goal of 12-step programs for smoking cessation (as modified from Alcoholics Anonvmous) is to have the smoker accept that he or she is powerless over smoking and work through 12 goals (or stepsl that help break down denial. Several organizations have outlined how to apply the 12-step model to smoking, and a na- tional self-help organization- Nicotine Anonymous- exists (110). However, there are no scientific tests of 12-step programs for smoking cessation. Exercise might be helpful as it is thought to increase self-esteem, relieve stress, emphasize the new role of an abstinent smoker a• a hcaith% rc•r•or:. .Itt.: r. cseicht gain. C*unrroIlc.i c.aiu.ltwr1• w ... , ,, smuktnL :eaianc,n hac c t+ruJU.C.I murc recent stuclle, hasc hccn po•Itlc; I I l. I:_ malc,r dlmcults ha> been pc,or:ompilan.c c.,t:' nr:,,.,.. remlt% e\eraic reclmen.. AIrhuu_h rc.c•nt rr•c.lr,;! W dlCatea pv':holtt,i'tcal Ivtlcrlt or:ur• %% Ith iim •rn4,t1•rl% actlvlry. whether nt.re,t:-lm_ Io%% •Ic% ci a"nlt% ntl,ht helptul in smuklm:-cea..ttlon ha• not hcc•n In summars'. exerclsc;a:tn lts u a promuln: thcral+.. Bloteedhack, familc therap.. Inn•rprr.mtal nccr.irc. and pss•chodynamlc theral+c- ha% n ccrn u.rJ c.lfii ornc•r drug dependencfea 138, and might hc- .tl+l+ii;.thic to smoktnt:.essanon; hu%.•e.er, therc.tre rlthrr nistir,vnl% a tes• descriptions of adaptln~, thr.r to trc•ar .niol.llt:. In summarc. none of these treatntcnt> ha%c uttl;rcnr evidence to he recommended. IA.ul+uncturc• I• occ•rcJ with somatic therapfes in the next.c•:nt m.- F. W\1AT1C; TREAT\1kNTs 1. 1 rurud uc•trurt Pharmacotherapies can he divided into replacement therapy. antagonist therapy, therapies to make drug in- take aversive, and nannicotine meJi:anuns that mimf: nicotine effects (1 13. 114 1. NonmeJfcanun somatic therapies include acupuncturr anJ devices. The fcillu..•- ing are brief descriptiuna of these therapies. For more infurmation, the reader is referred to nwrnt descriptive (51, 56. 62. 6-, -I, -2, 101. 11 .1-12 i) and meta-.tn.t- Iytic (3. 5-. 92. 115. 124-129f reviews. :. \'icutirtc• Replaccrnc•ut Tbc•r,trr a. Gcwls. The goal of nicutine replacement therapy is to relieve withdrawal, which will allow the pitieni to focus on habit and cundinunin~ fauturs when attempt- ing to stop smoking. After the acute withdrawal perfcr'd, nicotine replacement therapy is gradually reduced so that little withdrawal should occur. G. Dcscriptiun u% prudttcts. 1) Nicotine t'ruu. Vicutine ingested through the gastrointestinal tract is extensively metabolized on first pass through the liver (42). Nicotine gum (nicotfne Ix>'- lacrilex) avoids this problem via huccal absorption (42). The gum contains 2 or 4 mg uf nicotine that can he released from a resin by chewing (113). The original recommendation was to use one piece of 2-mg gum every 1S-30 minutes as needed for craving. More recent work suggests scheduled dosing (e.g.. I piece of 2-mg gum/hour). and 4-mg gum for highly nicutine-de- pendent smokers is more effective (62, 113). The origi- nal recommended duration of treatment was 3 months. Many experts believe longer treatment is more effective; however, the two trials of longer duration produced contradictory results (41). Nicotine absorption from the gum peaks 30 min- utes after beginning to use the gum (42). Venous nlcu- 12 Am / Psychiatry JS3:10. October 1996 Supplement
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Ni() ti() (.it A i) If 7 ThC' 1A rI'C, A.( '1 1, ..1-)wr1 (;milmlllo' NYI ION ki. INS I H l I I.ti OF Ill'. ~ L-1 - 7 -7 P-11M
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- Chapter 8 Pharmacology and Markers: Nicotine Pharmacology and Addictive Effects Jack E. Henningfield and Leslie M. Schuh INTRODUCTION Dosing characteristics of cigarette brands are estimated using machines that smoke representative cigarettes from each brand according to a protocol termed the Federal Trade Commission (FTC) method (Peeler, _ this volume; Pillsbury, this volume). This technology and methodology provide tar- and nicotine-dosing estimates of cigarettes that are misleading to consumers and do not accurately predict what level of tar and nicotine intake consumers will obtain by smoking a given brand of cigarettes (Henningfield et al., 1994). An understanding of the dependence-producing and other behavior-modifying effects of cigarette smoke is necessary to understand why the FTC method is a poor predictor of the. nicotine, tar, and carbon monoxide levels people obtain from cigarettes. Cigarette smoking behavior is influenced by nicotine dose, and smokers tend to maintain nicotine intake within upper and lower boundaries (Kozlowskl, 1989). In brief, nicotine produces dose-related tolerance, physical dependence, and discriminative effects (i.e., effects that people can feel, which modify mood and physiology), and smokers change their behavior in response to these effects. Unlike human smokers, machines are not nicotine dependent, nor do they modify their behavior based on the flavor of the smoke. The FTC method was developed in the 1960's to provide a relative ranking of nicotine, tar, and carbon monoxide yields from various cigarettes (Peeler, this volume; Pillsbury, this volume). This ranking has provided consumers with the false sense that they can tell precisely the amount of these substances they will obtain from a given cigarette. Since the 1960's there have been many advances in the understanding of nicotine and smoking behavior that can be useful in reforming this methodology. This chapter provides an overview of relevant research, including (1) physiological and behavioral pressures to sustain nicotine intake; (2) the relationship between smoking and nicotine dose; (3) determinants of compensatory behavior, including the role of nicotine and other factors, such as flavor; and (4) measurement of smoking and nicotine intake. CIGARETTE Several findings bear on the issue of the strength of dependence SMOKING AS on cigarettes. Although 70 to 90 percent of smokers are DRUG DEPENDENCE interested in quitting, only one in three succeeds before age 65 (Fiore, 1992). There is good and bad news about coronary Addiction Severity bypass surgery and even a lung removal. The good news is that these traumatic events are among the most powerful incentives to quit smoking. If one intervenes with patients who undergo these procedures, about one-half of them quit. However, the bad news is that the other half 113
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MCOTINE DEPENDENCE reported clonidine doubles quit rates i3e. 1_5. lb.;:. hut a rl,urtn dlsa~reed 1?,. The most cctmmctn side rtrrcts (it .Itmidrnr arr dr% mouth. scdztion. and constrpatrun , 16 ~,. Postural h%- porension. rebound hs•pertensurn, and depression arr rare with smr>ktnF cessation treatment 1 16 5,. Nr% rral studies ha%e suggested clonidrne is more etttcavr in women than in men: however. many studies ha%e tarled to tind this associatum d6ir:- .althc,ueh clonidine appears to increase quit rater similar to that or nicotine replacement thcrapc• the quantity and quality nf the scientific studies on cloni- dine are less than that for nicotine replacement therapy. .Nes•ertheless. clonidine may he an alternative tor smnk- ers who prefer not to receive nicotine and tor smokers who have failed nicotine replacement therapy 1l1/. b. Atrxiolytlcs. Anxien• is a prominent symptom of nicotine withdrawal i 16). In addition, smokinF de- creases some measures of anxiety and ma.• reduce stress-induced anxiety /1661; thus. temporaril.• replac- ing the anxiolytic effects of nicotine with another medi- cation during the first weeks of cessation might make cessation easier. Diazepam appears to decrrasr tuhaccu withdrawal, but in a well-conducted long-term clinical trial, diazepam did not increase abstinence /123). ft Blockers can act as anxiolytics. Placebo-controlled tri- als of inetoprolol, oxprenolol, and propranolol have not found that they decrease craving or increase ahsti- nence rates 1133). Older trials found that the nonhen- zodiazepine anxiolvtics meprohamate and hydrox.zine were not effective for smoking cessation (133). In sum- mary, the above anxiol.cics do not have sufficient evi- dence to be recommended. Buspirone is a serotonergic aganist, which acts as an anxiolytic hut produces minimal, if am•, sedation. abuse potential, or physical dependence. Major side ef- fects to huspirone are rare. Some short-term trials have reported that huspirone appeared to reduce nicatine withdrawal, hut others have failed to find this 1133). Buspirone improved short-term smoking cessation rates in unselected smokers and improved abstinence in high-anxiety smokers (123). Because of its favorable side effect profile and some evidence of effican•, buspi- rone is classed as a promising therapy. c. Antidepressants. A past history of depressian and dysphoria prior to, at the onset of, or during smoking cessation predicts failure to stop smoking; thus, and- depressants might be useful in helping smokers with these problems stop smoking 13. 167). In the only pub- lished long-term clinical trials, imipramine had no ef- fect on smoking cessation (123). but a more recent trial of nortripryline was positive (168). Two trials with flu- oxetine were completed some time ago hut the results were never published or presented (123). Short-rerm, trials with doxepin, tryptophan, and hupropion in un- seleaed groups of smokers have also reported prnmis- ing results (123). Many antidepressants have substantial side effects and a long delay in efficacy; thus, these treatments ma~ not be acceptable to the general population of smokers. A morr t,ku?,rJ drprrs.ant!- prior to ,mt,l:rr< wtth .1 (•+.t:t hi.u•n ,•.. %tho arr &:phuncat tnc ;rmror ,mokm:.~••.~r,.•.. : summar%. annJrprr<,ant, arr ;on•wcrr: .r treatment. ,f. Jtrnuul.tnr:. The co.tl here i• ro rrl+i.i;X rnr •rnnui.rnr rfrrczs or matnnr ~r.:.. rmrr„%rJ rner_% .ut,l ncm, with a medication irw thc nr.r %%ccl.• „t The one Itmg-rcrm .ru.i. „r a .rrmm.tnr n,un,f rh.u .tII•, phrtaminr. did nor m:rc.i•c ar`.nnvn,; 1: *. k un.ontrullcd trial cu`_r>c mcthcipncnw.itr.ic:rr.r•r• r,- hacco withdrawal 116`+1. Frnallc. it rl mui.inn %% rrr n,tnr.t to he effrcYtve. whether drt+rndrn;~- ,,,t tnr •tunui.inr ,a • curs s.•uuld need « t be examined. In .umrnar.. .tnnui.utr, lack sufficient evidence ut he rramimrnJr.l. c. Atrurccttcs. Anorectics werr u.rJ imtralk to:,,mh.tt postcessatutn hunger and weight c.un he:.tu.r thr•r arr two ot the most wrdel.• cucd reamm: n,r Jrtrrcultv m.t„r- ptnL smoking t-'r. Shtrrt-tcrnt trral, ut ss„mrn .vrth ss•eizht ctmcernc rtpiinrd that both rcntluratmnt• an.) phem•Ipropanolamine reduced l+t,ctcr..anun %s•rrLht _.wt and wme..•ithdrawal s%-mptum. anJ rn.rra.c J ah.nnrn. r (1_3). The results are tntrtLurnL, :rvrn the data that controlling weight by adding a dtrnma component m.t multicomptmenc program a•ttrsrn> rather than tml+rnve% abstinence rates 1: 8, '9). Fentlurammt• and phcnylprtr panolamine have few side erfctits. In .umman, both tit these medications lack sufficient rvrdrnce to hc recom- mended but are considered promising. 6. Scnson• rcphtc cnrcnt Black pepper extracts i 1-(11. circaicin / 1-I 1: Jeni- cttdnmzed tobacco 111721. t1.tvtuinL• 1171). and regcncr- ated (denirntinized) smukr 11"-lr all decrease ctgarrnc craving or withdrawal or suhxtitutr tor the satistac•tuon from cigarettes in laboratory tect.. A crtrrc :tcid inhaler has been developed and showed sonic promise in nvo clinical trials (1?.i, 176). As expected, this treatment has s•er.• few side effirccs. Sincr srnatry trcatmentc could he used not aniv as a stand-alone therapy hut also as an adjunct to traditional pharmacatherapies, this ippcars to he a promising treatment. 7. Other ntedicJti(jns Sodium bicarbonate has been u.ed to decrease the rate of urinary elimination of nicotine and therehv de- crease withdrawal symptoms (1123)). ACTH has been used to decrease ptutcessatian hyp<rl;lycemia (123). Anticholinergics have been used to reduce a hypathe- sized cholinergic rebound upon smoking cessation (123). Dextrose has been used to prevent smokers from mislaheling hunger as nicrxine craving (123). Homen- pathic remedies and nutritional supplements have also been proposed. For all of these treatments, the basic rationale and mechanism of action is suspect and con- trolled trials of long-term abstinence are lacking (123); thus, all lack sufficient evidence to he recommended. 16 Am J Psychiatry 1.5.1:1 0. OcMher 1996 Supplenrent
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Chapter 8 nicotine metabolite, has a half-life of about 20 hours (Cummings and Richard, 1988; Jarvis, 1989; Jarvis et al., 1987) and therefore persists in the body even longer. It is difficult to disrupt these patterns when people have access to cigarettes. In a study by Benowitz and colleagues (1986a), people switched from 30 to 5 cigarettes per day. Because they tended to smoke these S cigarettes much more intensely, they reduced carbon monoxide levels by only one-half and nicotine levels by only about one-third. Thus, nicotine intake remained high enough to sustain dependence. After quitting smoking, most people relapse quickly, and about one-third of the people who have quit smoking and remained abstinent for 1 year relapse (Fiore, 1992). As with alcohol and heroin, most nicotine relapses occur during the first 3 months of abstinence (Hunt et al., 1971). In fact, the determinants of relapse (e.g., degree of dependence and negative emotional states) and remission (e.g., substance-associated health problems and learning to manage cravings) are also similar across these three classes of drug dependence (U.S. Department of Health and Human Services, 1988). Relapse to nicotine dependence has been studied in greater detail than relapse to heroin, cocaine, and alcohol dependence. Data from a Mayo Clinic study showed that, with minimal treatment intervention, one-quarter of the people relapsed in 2 days and about one-half in the first week (Kottke et al., 1989). More recent data on people who quit on their own showed that about two-thirds relapse within 3 days (Hughes et al., 1992). The withdrawal syndrome can be debilitating in its own right, but in the long run, its worst health consequences may be that most efforts to quit smoking never survive the withdrawal phase (Hughes et al., 1992), thereby dooming one-half of persistent smokers to die prematurely because of their tobacco use (Peto et al., 1994). Much of the benefit of current nicotine medications is providing adequate nicotine replacement for that formerly provided by cigarettes to help more people remain nonsmokers during the important first few weeks of tobacco abstinence. NICOTINE Tobacco products come in many different forms. All have toxicities and DELIVERY dependence potential, and there is variation related to the type of tobacco SYSTEMS product and route of administration. Although the focus here is on cigarettes, at some point similar issues must be addressed with other tobacco products that currently have no dosage labeling. For example, moist snuff products vary widely in their nicotine-dosing capabilities, and there is evidence that the variation is accomplished primarily by manipulation of the pH level of the products by tobacco manufacturers (Henningfield et al., 1995; Djordjevic et al., 1995), but neither tobacco companies nor governmental agencies provide any form of nicotine dosage information to consumers except in cigarette advertising. The cigarette, which may be conceived of as a nicotine dispenser with smoke as the vehicle, is the most toxic and dependence-producing form of nicotine delivery. Nicotine is volatilized at the tip of a burning cigarette from 115
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or more soon return to smoking (U.S. Department of Health and Human Services, 1988). There are two lessons here. First, incentives and motivation are important factors in the treatment of nicotine and other drug dependencies. Second, incentives and motivation have limitations; even the threat of death is not sufficient for half these smokers to stop smoking. This is a tenacious addiction in which, despite so many people wanting and trying to quit, fewer than 1 in 10 has a 1-year success, and this means that only 2 to 3 percent of smokers stop smoking each year (Fiore, 1992). Indeed, as Kozlowski and colleagues (1989) show, more than half of heroin and cocaine users and alcoholics rate smoking cigarettes as harder to give up than these other drugs. Thus, there are strong biological pressures in nicotine-dependent humans that do not exist in machines to sustain addictive levels of nicotine intake. Clinical As with dependence on other drugs, cigarette smoking tends to be a Characteristics progressive, chronic, relapsing disorder (U.S. Department of Health and Human Services, 1988). The most notable distinction between cigarette smoking and other drug dependencies is that a much higher percentage of people who start smoking escalate and graduate to dependent levels than with other addictive drugs. About 1 in 10 smokers in this country is a low- level smoker, termed a "chipper," who smokes 5 or fewer cigarettes per day (U.S. Department of Health and Human Services, 1988); most of the rest show evidence of dependence. This Is in contrast to alcohol use, where 10 to 15 percent of alcohol drinkers are problem drinkers; the rest generally drink in moderation and at times of their own choosing (U.S. Department of Health and Human Services, 1988). % People do not start smoking a pack of cigarettes per day. They likely would become ill at that level of nicotine Intake. Rather, they start out with low levels. Over months and years, most people progress to higher and higher nicotine intake. They become tolerant; that is, nicotine loses effectiveness with its continued presence In the body, and it is necessary to increase the dose to maintain its effectiveness after repeated administrations. Eventually, smokers do more than simply tolerate high nicotine doses; they need continued nicotine to feel normal and function satisfactorily. At this point, smokers may go to great lengths to continue smoking and sustain their nicotine intake within upper and lower boundaries so that their intake does not fall low enough that they experience withdrawal symptoms or high enough to produce adverse effects (Kozlowski, 1989). An important aspect of the chronic nature of tobacco dependence is related to daily patterns of nicotine blood levels. When smokers wake up in the morning, some residual nicotine remains in their blood from smoking on the previous day. Blood concentrations rise as they smoke until, by midafternoon, most smokers' intake equals metabolism and excretion, and nicotine level stabilizes. Levels fall rapidly overnight, and the cycle resumes the next day. Thus, blood concentrations never reach zero unless the person quits smoking for more than a few days. Moreover, cotinine, an active
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Smoking and Tobacco Control Monograph No. 7 animals (Corrigall, 1991; Henningfield and Goldberg, 1983; Pomerleau, 1992; U.S. Department of Health and Human Services, 1988) and the negative reinforcement of withdrawal symptoms that also fuel the compulsion to smoke (Hughes and Hatsukami, 1992; Pomerleau and Pomerleau, 1984). Nicotine also produces increased expression of brain nicotinic receptors in humans and animals (U.S. Department of Health and Human Services, 1988). Taken together, these physiologic effects confirm that nicotine exposure alters the structure and function of the nervous system and leads to modification of behavior. Thus, there are physiological factors that drive smokers to sustain continued nicotine intake across changing delivery systems. Smokers may report that they feel impaired and distracted after only a few hours of abstinence, and their performance on various cognitive and psychomotor tasks can decline within approximately 4 hours (Heishman et al., 1994). Symptoms are rapidly reversed with resumed smoking or nicotine replacement, thus providing a potentially powerful source of reinforcement for continued smoking. The degree of reversal is generally proportional to the percentage of plasma nicotine that is replaced (Pickworth et al., 1989; U.S. Department of Health and Human Services, 1988). Data from a performance study indicated that when patients abstained from cigarettes and used placebo gum, they made more errors and took longer to complete a task than during their smoking baseline. When they were given 2 mg gum, their performance returned to baseline. With 4 mg gum, they did not do significantly better than at baseline, but 4 mg appeared to produce somewhat more reliable clinical effects than 2 mg (Snyder and Henningfield, 1989). ~ The same pattern of effects occurs with theta power, a measure of brain function (Pickworth et al., 1989). This nicotine-withdrawal-induced deficit can be completely reversed with nicotine replacement. When other volunteers resumed smoking, electrocortical potentials recovered quickly in all volunteers. Interestingly, these people did not like the gum, and they were not trying to quit smoking. The lesson is that nicotine replacement can maintain physiological function and cognitive performance. The conclusion relating to performance is not that nicotine makes the user perform better, faster, or more intelligently but that nicotine deprivation results in impairments that are quickly and dose-dependently reversed by nicotine readministration (Heishman et al., 1994). The nicotine-withdrawal-induced decline in performance has practical ramifications in policy decisions. Currently, the Federal Aviation Administration is examining its policies on smoking by pilots in the flight decks of commercial airlines. Because of the time course of nicotine withdrawal, If smoking were eliminated in the flight deck, acutely deprived pilots might suffer withdrawal-induced performance declines on flights longer than approximately 4 hours. Thus, the nicotine withdrawal syndrome poses a potential safety hazard if it is not rationally addressed by appropriate • strategies to detoxify pilots safely and treat their withdrawal symptoms with nicotine replacement medications.
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Smoking and Tobacco Control %,fonograph No. 7 which it is carried by particulate matter (tar droplets) deep into the lungs with inspired air. The nearly 2,000 °F microblast at the cigarette's tip is also the source of carbon monoxide and many other toxicologically significant pyrolysis products. Nicotine is rapidly absorbed in the alveoli of the lungs, concentrated in the pulmonary veins as a bolus, and pumped by the left ventricle of the heart throughout the body. Absorption characteristics are similar to those of gases, such as oxygen, that are exchanged in the lung from inspired air to venous blood (Henningfield et al., 1993). Thus, smoke inhalation produces arterial boli that may be 10 times more concentrated than the levels measured in venous blood (Henningfield et al., 1990 and 1993). Psychoactive effects have rapid onset and short duration, dissipating within a few minutes. This short duration requires the user to self-administer, the drug repeatedly, perhaps taking hundreds of puffs per day. The cigarette allows the smoker very fine, "fingertip," dose control. The powerful engulfing sensory effects are also important in dependence. It is not just the drug but the conditions and the cues that become associated with the drug that make nicotine dependence so tenacious. Finally, the cigarette is a convenient, portable system that permits easily repeated dosing. Benowitz (this volume) reviewed the pharmacokinetics of various nicotine delivery systems. Briefly, a cigarette produces a rapid spike of nicotine in the arterial blood. Smokeless tobacco products are also rapid, especially the higher pH tobacco products, and they require little practice for the user to achieve high nicotine levels. Whereas the nicotine dose obtained from a cigarette is largely determined by the behavior of the user, the nicotine dose obtained from a "chew" of smokeless tobacco is largely controlled by the product (Henningfield et al., 1995). In contrast to delivery from tobacco products, delivery of nicotine from polacrilex (nicotine gum) is slower and takes a great deal of practice and work to achieve even modest nicotine plasma levels. Transdermal nicotine medications (patches) provide slow absorption-so slow that users cannot reliably detect nicotine's effects. The speed of delivery is clearly an important determinant of addictive effects, and the cigarette, like crack cocaine, provides an explosive dose of nicotine. NICOTINE'S Nicotine is a fascinating psychoactive drug. It was used to help map the EFFECTS cholinergic nervous system early in the 20th century. Much of receptor theory and many of the methods used to study competitive agonists and antagonists were developed at the turn of the century using nicotine (Langley, 1905). Nicotine has diverse effects, not only in the brain but also in the adrenals and skeletal muscles. These diverse effects may explain why a smoker reports that on some occasions cigarettes have relaxing effects and on other occasions, stimulating effects. This has been referred to as a paradoxical effect, but it is not paradoxical at all; other drugs generally referred to either as sedatives or stimulants also produce both sedating and stimulating effects (Gilman et al., 1990). Like the effects of these other drugs, nicotine's effects are complicated; they depend on the dose, the time since dosing, how the
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Smoking and Tobacco Control Nlonograph No. 7 and inhaling could result in the extraction of substantial amounts of nicotine (Butschky et al., 1995). Compensatory Compensation is nicely described in the B&W documents (Brown and Behavior Williamson, 1984) as "the tendency for a smoker to obtain similar delivery, intake and uptake of smoke constituents on a daily basis from a variety of products with different standard (machine-smoked) deliveries." . As the B&W researchers noted, if smokers are dependent, then the nicotine they receive from cigarettes can be supplemented by other forms, and this will reduce smoking. Likewise, cigarettes of different strengths are smoked differently; that is, smokers given low-delivery cigarettes smoke them more intensively and vice versa. In fact, this is what has been found in many studies (U.S. Department of Health and Human Services, 1988). Cigarette consumption increases in response to reduced nicotine, and most compensation occurs at the individual cigarette level, not by cigarettes per day. Whereas people given cigarettes of lower nicotine yield also may smoke a few more cigarettes per day, they smoke each of the cigarettes more intensely to obtain proportionately more nicotine than the rating of nicotine yield would suggest (Hill and Marquardt, 1980; Russell et al., 1980; Benowitz et al., 1983; Robinson et al., 1983). When people are given nicotine gum and their smoking is measured, smoking decreases as the nicotine gum dose increases (Nemeth-Coslett and Henningfield, 1986). When mecamylamine is administered to antagonize nicotine's effects, people smoke more cigarettes, take mofe puffs per cigarette, and take in more total smoke, as can be seen by incregsed carbon monoxide level (Nemeth-Coslett et al., 1986; Rose et al., 1989). Taste and other sensory factors are also impcrtant modulators of human smoking behavior (Butschky et al., 1995; Rose and Behm, 1987; U.S. Department of Health and Human Services, 1988). This finding addresses why the nicotine dependence issue is relevant to why the FTC method of measuring tobacco smoke constituents is seriously flawed. Simply put, the FTC method uses machines that do not change their behavior to self-administer a preferred nicotine dose or in response to the taste of the smoke, as human smokers do. It may be an accurate predictor of what smoking machines obtain under specifically programmed conditions, but it is not an accurate predictor of what people get from cigarettes. The dose-response relationship between FTC ratings and plasma nicotine levels is weak, except at low doses (Russell et al., 1980 and 1986; Rickert and Robinson, 1981; Benowitz et al., 1983 and 1986b; Robinson et al., 1983; Gori and Lynch, 1985; Maron and Fortmann, 1987; Coultas et al., 1993). The relationship between cigarette dosage ratings and plasma nicotine levels may be better in studies using research cigarettes where nicotine content
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Chapter 8 The duration of the nicotine withdrawal syndrome varies across individuals, but on average, the acute physical syndrome is worst during the first month. Gross and Stitzer (1989) studied the time course of the nicotine withdrawal syndrome in detail. In their study, people quit smoking and received either active or placebo nicotine gum. People who received active gum chewed an average of 6.9 pieces of 2 mg gum per day, which provided less nicotine than they were obtaining by smoking cigarettes. People given placebo gum gradually decreased their intake from 6.8 pieces per day during the first week of treatment to 4.9 pieces per day by the 10th week. The nicotine gum substantially reduced withdrawal symptom severity relative to that observed in placebo subjects. Nicotine's Nicotine provides many effects that cigarette smokers may consider useful. Beneficial These include weight control, mood control, and preventing withdrawal Effects symptoms (U.S. Department of Health and Human Services, 1988). The issue of whether nicotine would provide substantial cognitive enhancement in healthy persons who had never been nicotine dependent is controversial. In nonsmokers, nicotine administration can increase finger-tapping rate and slightly (but significantly in some studies) attenuate the deterioration in attention that occurs during protracted testing (Heishman et al., 1994). However, complex cognitive performance may be impaired by nicotine in cigarette smokers as well as nonsmokers (Heishman et al., 1994). On the other hand, there is no question that nicotine intake restores withdrawal- induced deficits (Snyder and Henningfield, 1989). Nicotine intake also may provide some level of cognitive enhancement in persons who are cognitively impaired by Alzheimer's disease (Heishman et al., 1994; Sahakian et al., 1989; Newhouse and Hughes, 1991). One of the Brown and Williamson Tobacco Corporation (B&W) documents made available for the National Cancer Institute conference on the FTC cigarette test method also supported the conclusion that nicotine's central nervous system effects contribute to the strong motivation to use tobacco products. The document concluded that to understand smoking, just as any other behavior, it is necessary to consider it as a process embedded within everyday life .... It is apparent that nicotine largely underpins these contributions through its role as a generator of central physiological arousal effects which express themselves as changes in human performance and psychological well being. (Brown and Williamson, 1984) SMOKING AND Nicotine dosage is an important factor in smoking behavior. NICOTINE DOSE Currently available cigarettes allow people to fairly easily administer the nicotine dose they need or desire (Henningfield et al., 1994). This was true of a low-content cigarette, NEXT, that was marketed a few years ago and removed from the market following poor sales, even though taste and draw characteristics were similar to conventional cigarettes. With that cigarette, the nicotine content was so low that no amount of compensatory puffing 119
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Chapter 8 drug was administered, which responses are being measured, and other factors (Henningfield and Keenan, 1993; Pomerleau and Rosecrans, 1989). If people with histories of drug abuse are given nicotine, they like the nicotine; that is, liking scale scores increase with greater doses within a certain range of parameters (Henningfield et al., 1985). Among drug abusers, similar findings are_reported for morphine and amphetamines but not for drugs that have little psychoactivity (Fischman and Mello, 1989). Such psychoactive effects are predictive of addiction potential and are correlated with the ability of a drug to serve as a reinforcer for animals and humans (Griffiths et al., 1980). Nicotine is psychoactive in humans and is readily discriminated by animals; several forms of nicotine delivery have been shown to serve as reinforcers for animals and humans (U.S. Department of Health and Human Services, 1988). Physical The cellular and neurological changes that lead to tolerance Dependence also lead to physical dependence so that when people abruptly and Withdrawal discontinue tobacco use, withdrawal occurs (U.S. Department of Health and Human Services, 1988). Withdrawal onset begins within a few hours of the last cigarette; symptoms include decreased cognitive capabilities and heart rate and increased dysphoria or depressed mood, insomnia, craving, anxiety, irritability, restlessness, appetite, and tendency to smoke (American Psychiatric Association, 1994; Hughes and Hatsukami, 1992). Altered brain electrical potentials and hormonal output are generally opposite in direction of those produced by acute nicotine administration, and decrements in evoked electrical potentials of the brain indicate impaired information processing capabilities (Pickworth et al., 1989; U.S. Department of Health and Human Services, 1988). Nicotine dependence seems to be mediated primarily by the activation of nicotinic cholinergic receptors in the brain (U.S. Department of Health and Human Services, 1988) and secondarily through the cascading effects of nicotinic systems to modulate levels of hormones such as epinephrine (adrenaline) and cortisol (Pomerleau and Pomerleau, 1984; U.S. Department of Health and Human Services, 1988). The mesolimbic dopaminergic reward system, which mediates the ability of cocaine to produce dependence, also has been implicated in nicotine dependence (Corrigall, 1991; U.S. Department of Health and Human Services, 1988). The cells of this system are located in the ventral tegmental area of the midbrain. Axons project to the limbic system-specifically, to the nucleus accumbens, olfactory tubercle, nuclei of the stria terminalis, and parts of the amygdala. Behaviors followed by such neural activation can become extremely persistent. Cortical effects of nicotine administration include changes in local cerebral metabolism (London and Morgan, 1993) and electroencephalogram results (Jones, 1987). Prominent endocrine effects include release of catecholamines, serotonin, prolactin, growth hormone, arginine vasopressin, beta-endorphin, and adrenocorticotropic hormone (Pomerleau and Pomerleau, 1984; U.S. Department of Health and Human Services, 1988). These effects mediate both the positive nicotine reinforcement sought by smokers and even 117
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Chapter 8 varies. With other drugs, compensation can be diminished when the cost of compensation increases. That is, if a drug becomes too costly in terms of expense or physical difficulty in sustaining intake, users may not compensate as effectively and will not administer as much of the drug as they did when the cost was lower (U.S. Department of Health and Human Services, 1988; Lemaire and Meisch, 1985; Bickel et al., 1993). Thus, if cigarettes have low enough nicotine contents, smokers would be expected to adjust over time to lower nicotine levels rather than spend the time and money necessary to maintain constant dose intake. Conversely, most smokers probably would not smoke 160 to 2001ow-nicotine-content cigarettes per day to continue to receive the intake that they previously obtained from conventional cigarettes. Measurement of The role of dependence is assumed by the authors and the tobacco Smoking and industry to be important determinants of nicotine intake. Brown Nicotine Intake and Williamson (1983) noted the basic assumption is that nicotine, which is almost certainly the key smoke component for satisfaction, is fully released to the body system before exhalation takes place. It is essential, therefore, to quantify the change in chemical composition between inhaled and exhaled smoke under different smoking conditions. Cigarette dose determination is indeed complicated, and some may suggest that it is so complex that use of the flawed FTC method might as well continue simply because it has been used for nearly 30 years. However, such a conclusion contradicts the enormous research advances made over the past 30 years. This research can be used to devise a better method. Furthermore, the complexity of dose determination is not unique to cigarettes. The Food and Drug Administration (FDA) faces this issue routinely whenever a manufacturer submits a new drug. Unless the drug is injected into a vein, determination of dosing is complicated. If the drug is delivered by an inhaler or oral capsule, many factors must be and are considered so that consumers are provided with realistic estimates of what they will get. In particular, they are provided with information relevant to the maximal doses that they are likely to receive from a drug-delivering product. To provide accurate dosing information for drug delivery systems, FDA uses different methods as indicated by the chemical and its delivery system; moreover, verification of dosing estimates is accomplished in human bioavailability testing studies because, In the final analysis, we care about the dose that people receive, not the machine-derived dose. Also, if there are factors that produce major changes in bioavailabilIty, such as whether the drug is taken with food or on an empty stomach, this can be indicated in the labeling. 121 cn 1~ J J 0 J r ~P
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NlCOTIN'E DEPENDENCE TABLE 2. OSM.IV Diagnostic Criterla tor Substsnce tlependence and Eaamples of Their ApDttcatron to Nicotine Depenoence ~ 10 A maradaon.e pattern or sutntan;e uwe. ieadrnc to ;irm;aliv stgntn;anr tmrarrr::r: ,,• :,.:r ... as manrrested h% tnree -or more- or tne rolrowrnc. o:;urnnc at an% time in tne +amc :: :nor.rr rcrio,; Crrrerra Tolerance. as decad by either A need tor markedly increased amounts ot the substance to a;hre.•e intoxication or desrred ettect \larkedl.• diminished ejfea with continued use ot the same amount or the substance Most smui.en es;alare u.e n• ! ,r nrrr; r% a_i. : .ihsen;e or nauxa. ,Lzzme•,. r:.- a5thdraw•al. as manifested bs• either The characteristic withdrawal syndrome tor the substance The substance is taken to relieve or avoid wtthdrawal ss•mptoms The substance is orten taken ut larger amounts or over a longer pe- rtod than was intended There is persistent desire or unsuccessful effort to cut down sub• stana use A great deal of nme is spent in acmities necesure to obtain the suhu stance. use the substance or recover trom its eftects Important soctal. occupational or recreational activities are pven up or reduced because of substance use The substance use is continued despite knowledge of having a pert srstent or recurrent physical or psychological problem that is likely to have been caused or exacerbated bv the substance ke table 4 \tan% smokers Ircht up rmme.iratei% atter rcrn; in .r .n,,... -rrrc .rr..r Most smokers do not intend ta.mai.e 3 %r.tr, rarrc. nur in ra.c. over '0'.:onnnue to use -''0 of smoken have meJ to stup. or rhaNa• h.t%e nut ^rrn able to stop despite repeated anempts anj onk or ..ir. quttten are successful Leaving worksite to smoke ' \or taking a tob due to on•ruh .mukm~ restrr.-trun. \tan.• smokers have heart dtaease. ~;hrunt: ohctru:n.c pulmurt.rr% disease or ukers and contrnue to smoke TABLE 3. Items and Scorittg for Fagerstrom Test for Nk:ofine Dependence (11) tobacco, a desire tur sweets, increased Questions Answers Potna coughing. and impaired performance 1. How soon after you wake up do you smoke your Within S minutes ; first cigarette? 6-30 minutes = 31-60 minutes 1 After 60 minutes 0 2. Do you find it difficult to refrain from smoking in Yes 1 places where it is forbidden: e.g.. in church. at the libran•, in the cinema. etc.? No 0 3. Which cigarette would you hate most to give up? The first one in the mormnE I All othen 0 4. How many cigarettes/day do you smoke? 10 or Iess 0 11-20 1 21-30 • 31 or more 3 S. Do you smoke more frequentlv during the firsc Yes 1 hours of wakutg than duruy the rrrst of the day? No 2 6. Do you smoke if yots an so ill that you are in bed Yes 1 most of the day? No 0 oxide in tobacco smoke rather than nicotine itself (24, blood levels of several psychiatric medications (table 5) 25). Smoking cessation dramatically reduces the risk of (8). For example, smoking decreases clozapine and heart disease and cancer and prevents continuation of haloperidol levels by 30% (8). This effect appears to be the decline in lung function in those with chronic ob- due, not to nicotine, but rather to the.effects of ben- structive lung disease (18). zopyrenes and related compounds on the P4S0 system. Withdrawal symptoms can also mimic, disguise, or 2. Nicotine withdrawal aggravate the symptoms of.other psychiatric disorders or side effects of medications (table 6) (8). For example, The DSM-N criteria for nicotine withdrawal are listed when an alcoholic smoker who is also nicotine depend- in table 4. In addition to these symptoms, craving for ent is admitted to a smoke-free ward for alcohol detoxi- on vigilance tasks may occur (16. 17). Withdrawal symptoms heFin within a few hours and peak 24-48 hours after cessation (17). Most symptoms last an * average of 4 weeks, hut hunger and craving can last 6 months or more (17). Nicotine withdrawal symptoms are due, in large part, to nicotine depriva- tltin 116. 17). Cessation of smoking can cause slowing on EEG, decreases in cor• ttsol and catecholamtne levels, sleep EEG changes, and a decline in metabolic rate (16). The mean heart rate decline is about 8 beats per minute, and the mean weight gain is 2-3 kg (16). Withdrawal ll b is usua y most severc from cigarene a - sanence compared to other forms bf to- bacco and nicotine medications (16, 17). As with all withdrawal syndromes, the severity varies among patients (16). Cessation of smoking can produce clinically significant changes in the 4 A»r J Psychiatry 153:10, October 1996 Supplement
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6. 5MO1:ERS vi-HO H.-\%•E FAILED I\iT1AL TR1=-\T\1E\T 1. DcNtruttun n! Xrutrp This group Is compused ot smokers who have talied a rnal or a known ertectice tarmal therapy Ir._.. hehj% - u,r therapy or ntccuane replacementr. 2. .-1 sscs: mcnt .r. Adc,]u,tcr t,/ prior tbcr,tpr. As with treatment tall- ures with other psychiatric disorders. a rlrst cunsldera- tum is the adequacy of prior treatment I I11I• How many sessions ot behavior therapy were attended'c What was the quality, ot the behavior treatment in the last quit anempt- What were the doses of gum or patch used? What was the duration of therapy*- What Was the level of compliance with the psychosocial or somatic ther- apy? How long did the patient remain abstinent? b. Gtuse of relapse. Another important consideration is to determine the perceived cause of the relapse 11111. Was the relapse due to uncontrolled withdrawal symp- toms. environmental stressors. alcohol use. negative or positive m<od, or being around other smoken'r V('ere there factors ie.~e,., farriooe. life dis,,,ppointments, ,:at::= il.•/social stressors) that undermined cessation: c. Motivatiotr to stop. The clinician should encourage the patient to try to quit again, and if the patient agrees. a new quit date should he set jllj. What was the pa- tient's satisfaction with prior treatments: What did he or she learn from prior failures'r If the patient is not ready to tn• aGain. what are his or her fears and what are the barriers to attempting again3 What changes does the patient think need to he made hehtre another attempt is made? d. Search jur cu»rnrhidit;r. NIost smokers have not been assessed for psychiatric or alcohol/drug abuse problems initially and such problems interfere with ce.- satitm (2. 167); thus, screening for such disorders is in- dicated Illj. In prior studies, 1 i':~-2U%,, of he•avy smok- ers have current and up to 3S'.., have past alcohol problems (186) Similarly. 40"~t of smokers seeking treatment have a past history of depression /2, 167). .3. Psychiatric mmtagementhae ojpst•cht,sucial and pharmacological treatments a. Prior treatment inadequate. If the prior treatment appeared appropriate but was inadequately imple- mented. the therapy may he repeated with changes to insure the fidelity of therapy, compliance, adequate dose and duration, etc. 111111. h. Prior treatment adequate. If the prior treatment was appropriate and adequate, the psychiatrist should attempt to determine whether the relapse was due cc>, withdrawal symptoms versus nonwithdrawal causes. !1 Relapse due to taithdratcal. If the prior relapse appeared to he caused by withdrawal symptcr'matolcx3Y and the patient has not previousl.• been treated with nicotine replacement, nicotine patch therapy is apprtr I+rr,tte 111. It the I+artrnr it.t, rrrr: .t,w..lu .:-,.rc., t, - nlcutlnr I+at:it tnc•rar•. rnrr o.,nr,nn, ll . ,. pat:h /+lu• nm:rxtnr ,um I II.. Ittottutc• tt.t•.t~ •r-.1% II . htchrr-Jctsc nl;ttttnr pat;h IIII -m.t. rk pl- rr-rrr.tttn_ wlth nl;tmnr r.rt;^ tnrr.tr~ ~. n, c t-. etrrctl%c• I-lS• Is-• I\.,% .(.r u! m.~tnnt n.t..l spra% 1, rr:umntrn.irJ r`r;au•c• thr. Jc•ir.c•r% n,tt,lr rrt. Juce, a nutrr httiu,-Itl,c• c•rrc•;t rn.rt mt_ht hc•ttcr r.nr%, a•IthJr.tcs•.tl and ;r.tc In~ 1111i I.;r, . U5.c ot nt,;lttlnc• na•.rl .rr.t% Intrl.lll. .tttJ :ni •• SN'Itihlng tt, nt:t.t111C (`.er:n or tllt .tNl,ttlltlt.tttt tl•, ~~ nicotine na,al .I+r.t. •rlt.i rtr;t,tutt r.tr;it it.l.: .tla. r.;r proposed 1 114, hut h.tcc• tu+t h:rn tc•tr.:. Tiu• r,ttl.nt.ut tor the use ttt :htntdutc• t, •Imrk to tn .t mc•,ir;.tttttt! trctm a Jitterenr:la,.. A rtnal pt~..lialu. t, .. ntrrtttn•tn. treatment ha.eJ un the ryrc ttr cclncdr.m.tl .% ct,pr- tItt, ie.L.. antiJe{+ressants tt,r wIth.lrawal-In.lu,r,l sronl. AIthccuLh IuLr;al. tht••tr.rros% h.t• Itt+t k.•.•r1 .1.1.'• quately reshd. ?t Rcl.tpsc•.lut• tt, rtttntt•reh,Ir.ttt•.tl 4tn•>•..•. It th.• smoker has relapsed due tu t ,rrr.,tul lire cc rnr .utJ h.r• ncu previously been treated with Lchacutr thc•r.rpc. it should he considered. It the pattcnt h.rs alrraJ% had Ik•- ha.•ior therap.•, tsvt+ %:hctrtx• are as.tilahlr: I 1 more ttt- tenst=•r; behavior therapy jiiij ttr :1 IKh,ts•a+r thcrap. with a different content or tnrntat; i.r.I rrrtui+ thc•rap%, individual therapy, :umhlnrJ InJis•IJual and group therap}•, or involvement Itr tantih• memhcrs 11111. Whether thesr treatments would he etfectis•e for those who have failed prior behavior thrrap.• has nor been tested. Switching ttr nctnhrhas•utral l+sy~ha.c><ral treat- ments Ir.g., hypnosis or 12-step tlts•r;tpy1 is nor ncrnn- mended Ixwause there is no empirical support tttr their etfic;tc.-. il (anrrl,tttc•tf thcr,t/r~•. tittmrnmc% it is Jittr:ult to distin~;uish withdrawal s•rr.us nonwithdrawal cau.r•Itt relal+sc. In this casr, the patient may hc a canJiJatr tttr combined pharm;tculttr:ical .rnd (khas•ictr therapy 1128. 1?yl 1111. 4) Rcy<•rntl. When the trrarrnz r..•chlatn.r JtK•% not have the knowledge nc•cc..ar.• to Implcmcnt the trcatmcnt, outlined here or it the stratcgiv% are admin- i.tcn-d and the smoker is nctt able to ytnt, refcrral to someone who specializes in treating nicotine JclxnJ- ence should he u+nsidcn•d 11111. .il Irtp.tttc•ttt prr~gr,tms. An inpatirnt model fttr smcrkingcessatian ha. hern deurihrJ I I tt'11 anJ apl+ears to produce high quit ratrx, especially given thr highly nicatine-delxndent smokers enrolled. There are no con- trolled trials that strhstanriate this at the current time. C. TREAT.\tE\T OF SMUKF.RS ON SMnKE-FREE WARDS 1. I ntrfultrctittn This section focuses on psychiatric patients on smoke-free wards, hut the same principles apply to smokers tr,n general medical wards.ren in consultation and tc>'smukers in smttke-fn-e nttnmcdical set