Tobacco Documents Online

~ _ APPENDIX B i Coments of Philip *orris U.S.A. ~ Dockets 94P-0069, 94P-0077 ! I I I I I I I I I I I I I I I SUBMISSION OF PHILIP MORRIS USA AND THE AMERICAN TOBACCO COMPANY TO THE DRUG ABUSE ADVISORY COIgiITTEE IN CONNECTION WITH ITS MEETING ON AUGUST 2, 1994 Volume 3.01 ~

I U I I I ~ I I I I I I I I I I Tab Publications Alexander B.K. A Canadian Perspective on Drug Policy. Pharmacological Biochem Behav 46(2):497-98, 98 (1993) ..... 1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. (4th ed. 1994)...2 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. (3rd ed. rev. 1987) ........................................ 3 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. (3d ed. 1980)....4 Appenzeller O. What Makes Us Run. New Eng J Med 305(10):578 (1981) .......................... 5 Balfour D.J. "The Neurochemical Mechanisms Underlying Nicotine Tolerance and Dependence." in Pratt, J.A. (ed) The Biological Bases of Drug Tolerance and Dependence (1991) ...................... 6 Balfour D.J. The Psychopharmacological and Neurochernical Consequences of Chronic Nicotine Administration. In: Warburton D.M. (ed.) Addiction Controversies (1990) ............................ 7 Benowitz N.L., Henningfield J.E. Establishing A Nicotine Threshold for Addiction: Implications for Tobacco Regulation. New Eng J Med 331(2):123 (1994) .........................................8 Benowitz N.L., Jacob P. Intravenous Nicotine Replacement Suppresses Nicotine Intake From Cigarette Smoking. J Pharmacol Exp Ther 254:1000 (1990) ............ 9 Benowitz N.L., Peyton J. Daily Intake of Nicotine During Cigarette Smoking. Clin Pharm Ther 35:499 (1984) ........ 10 Benowitz N.L., Peyton J., Denaro C.75 Stable Isotope Studies of Nicotine Kinetics and Bioavailability. Clin Pharm Ther 49:270 (1991) ............................ 11 Best J.A., Wainwright P.E., Mills D.E., et al. Biobehavioral Approaches to Smoking Control. In: Linden, W. (ed.) Biological Barriers in Behavioral Medicine 63 (1988) ............................ 12 - i -

I 1 I I I I I I I I I I I I I I Tab Boren J.J., Stitzer M.L., Henningfield J.E. Preference Among Research Cigarettes With Varying Nicotine Yields. Pharmacology Biochemistry & Behavior 36:191 (1990) ................................... 13 Borland R. Slip-Ups and Relapse In Attempts to Quit Smoking. Addictive Behaviors 15(3):235 (1990) ............ 14 Bozarth M.A., Drug Addiction as a Psychobiological Process. In: Warburton D.M. (ed.). Addiction Controversies 112-134, 121 (1990) ........................ 15 Bridges R., et al. Population Characteristics and Cigarette Yields as Determinants of Smoke Exposure Pharmacology Biochemistry & Behaviour 37: 17-28 (1990) ............... 16 Bridges R., Humble J., Turbek A., Rehm S. Smoking History, Cigarette Yield and Smoking Behavior as Determinants of Smoke Exposure. Eur J Respir Dis 69 (Supp. 146):129 (1986) ................................17 Carnes P.J. Out of the Shadows: Understanding Sexual Addiction. (1992) ................................ 18 Centers for Disease Control, Morbidity and Mortality Weekly Report 42(26):504-07 (July 9, 1993) ............... 19 Cerny L., Cerny K. Can Carrots Be Addictive? An Extraordinary Form of Drug Dependence. Brit J Addict 87(8):1195 (1992) ............................... 20 Chapman C.L., De Castro J.M. Running Addiction: Measurement and Associated Psychological Characteristics. J Sports Med Phys Fitness 30(3):283 (1990) ......................................... 21 Clark W.G., Craig B.D., Johnson A.R. Goth's Medical Pharmacology (1992) .............................. 22 Collins A.C. An Analysis of the Addiction Liability of Nicotine. Adv Alcohol Subst Abuse 9(1-2):83 (1990) ...... 23 Collins A.C., Bhat R.V., Pauly J.R., Marks M.J. Modulation of Nicotine Receptors by Chronic Exposure to Nicotinic Agonists and Antagonists. In: Bock G., Marsh J. (eds.) The Biology of Nicotine Dependence (1990) ................ 24 Colt E.W., Wardlaw S.L., Frantz A.G. The Effect of ~ Running on Plasma B-Endorphin. Life Sci 28(14):1637 (1981) .......................................25kZ Damon J. E. Shopaholics: Serious Help for Addicted ~ Spenders. (1988) ........................................2~ 00 00 - ii - ~ ~

I 1 I I I I I I I I I I I I I 1 I I Tab Daughton D.M., Heatley S.A., Predergast J.J., et al. Effect of Transdermal Nicotine Delivery as an Adjunct to Low-Intervention Smoking Cessation Therapy: A Randomized, Placebo-Controlled, Double-Blind Study. Arch Intern Med 1551:749 (1991) ..... 27 Fagerstrom K.O., Schneider N.G. Measuring Nicotine Dependence: A Review of the Fagerstrom Tolerance Questionnaire. J of Behav Med 12(2):159 (1989) ......................................... 28 Fagerstrom K.O. Tolerance, Withdrawal and Dependence on Tobacco and Smoking Termination. International Rev of Applied Psychology 32:29-52 (1983) ................................................... 29 Fiore M.C., Novotny M.D., Pierece J.P., et al. Methods Used to Quit Smoking in the United States: Do Cessation Programs Help? JAMA 263(20):2760 (1990) ........ 30 Foulds J., Stapleton J., Feyerabend C., et al. Effect of Transdermal Nicotine Patches on Cigarette Smoking: A Double Blind Crossover Study. Psychopharmacology 106(3):421 (1992) ............. 31 Garvey A.J., Bliss R.E., Ward K.D. Predictors of Early Relapse. Pharmacol Biochem Behav 36(2):424 (1990) ......................................... 32 Gazzaniga M. Mind Matters (1988) ............................. 33 Glassman A.H., Jackson W.K., Walsh B.T., et al. Cigarette Craving, Smoking Withdrawal, and Clonidine. Science 226:864 (1984) ....................... 34 Gottlieb A.M., Killen J.D., Marlatt G.A., et al. Psychological and Pharmacological Influences in Cigarette Smoking Withdrawal: Effects of Nicotine Gum and Expectancy on Smoking Withdrawal Symptoms and Relapse. Journal of Consulting and Clinical Psychology 55(4):606 (1987) ..................... 35 Gravelle J.G., Zimmerman D. Cigarette Taxes to Fund Health Care Reform: An Economic Analysis. Congressional Research Service (1994) .................... 36 Greden J.F. Caffeine and Tobacco Dependence. In: Kaplan H.I., Sadock B.J. (eds.) Comprehensive Textbook of Psychiatry IV (1985) ......................... 37 Griffiths M.D. Pinball Wizard: The Case of a Pinball Machine Addict. Psychol Rep 71(1):160 (1992) ............ 38

t I I Tab Griffiths R.R., Woodson P.P. Caffeine Physical Dependence: A Review of Human and Laboratory Animal Studies. Psychopharmacology 94(4):437 (1988) ................................................... 39 I I I I I ~ I 1 I I I Gunn R.C. Reactions To Withdrawal Symptoms and Success In Smoking Cessation Clinics. Addictive Behaviors 11:49 (1986) ......................... 40 Hasenfratz M., Baldinger B., Battig K. Nicotine or Tar Titration in Cigarette Smoking Behavior? Psychopharmacology 112:253-58 (1993) ..................... 41 Hatsukami D.K., Hughes J.R., Pickens R. W. Blood Nicotine, Smoke Exposure and Tobacco Withdrawal Symptoms. Addictive Behaviors 10:41317 (1985) ........... 42 Henningfield J.E., Clayton R., Pollin W. Involvement of Tobacco In Alcoholism and Illicit Drug Use. Br J Addict 85:279 (1990) ............. 43 Henningfield J.E. Pharmacological Basis and Treatment of Cigarette Smoking. J Clin Psychiatry 45 (12 Sec. 2):24 (1984) ...................... 44 Hetherington M.M., MacDiarmid J.I. Chocolate Addiction: A Preliminary Study of Its Description and Its Relationship to Problem Eating. Appetite 21(3):233 (1993) ....................... 45 Hirsch A., Slama K., Alberisio A. Smoking Cessation Methods: Recommendations for Health Professionals. Eur J of Cancer 30A(2):253 (1994) ........ 46 Hofer I., Nil R., Battig K. Nicotine Yield as Determinant of Smoke Exposure Indicators and Puffing Behavior. Pharmacology, Biochemistry & Behavior 40:139 (1991) ................................... 47 Horn D. Psychological Analysis of Establishment and Maintenance of the Smoking Habit. In: Krasnegor N.A. (ed.). (1979) ............................. 48 i Huber G.L., Padina R.J. Appetitive Functions and Dysfunctions: Tobacco. Seminars in Respiratory Medicine 11:1 (1990) ..................................... 49 Huebner H.F. Endorphins, Eating Disorders and Other Addictive Behaviors. (1993) ....................... 50 1, I Hughes J.R. Pharmacotherapy for Smoking Cessation: Unvalidated Assumptions, Anomalies, and Suggestions for Future Research. J of Consulting and Clinical Psych 61(5):751 (1993) ........... 51

Tab I Hughes J.R. Risk-Benefit Assessment of Nicotine Preparations in Smoking Cessation. Drug Safet 8(l):49 (1993) 52 y .................................... t Hughes J.R., Oliveto A.H., Helzer J.E., et al. Should Caffeine Abuse, Dependence, or Withdrawal Be Added to DSM-IV and ICD-10? Am J Psychiatry i 149(1):33 (1992) ......................................... 53 I Hughes J.R. Tobacco Withdrawal in Self-Quitters. J of Consulting and Clinical Psyc 60(5):689 (1992) ................................................... 54 Hughes J.R., Gust S.W., Skoog K., et al. Symptoms of I Tobacco Withdrawal: A Replication and Extension. Arch Gen Psychiatry 48:52 (1991) ......................... 55 I Hughes J.R., Higgins S.T., Hatsukami D. Effects of Abstinence from Tobacco. A Critical Review. In: Kozlowski L. et al. Research Advances in Al bl h l d co o an Drug Pro ems 10:317 (1990) .................. 56 I Hughes J.R., Higgins S.T., Bickel W.K. Report From Human Behavioral Pharmacology Laboratory University of Vermont. Brit J Addiction 85:441 (1990)...57 I I I I I Hughes J.R. Withdrawal Symptoms and Smoking Cessation. Am Rev of Respiratory Disease 141 (4, Pt.2): A560 (1990) .............................................. 58 Hughes J.R., Gust S.W., Keenan R.M. Nicotine vs. Placebo Gum in General Medical Practice. JAMA 261(9):1300 (1989) ................................................... 59 Hughes J.R., Gust S.W., Pechachek T.F. Prevalence of Tobacco Dependence and Withdrawal. Am J Psychiatry 144(2):205 (1987) ........................................ 60 Hughes J.R. and Hatsukami D. Signs and Symptoms of Tobacco Withdrawal. Arch Gen Psychiatry 43:289 (1986) ................................................... 61 Jaen C.R., Cummings K.M., Zielezny M., et al. Patterns and Predictors of Smoking Cessation Among Users of a Telephone Hotline. Public Health Reports 108(6):772 (1993) ......................... 62 I Jaffe J.H. Current Concepts of Addiction. In: O'Brien C.P. (eds.) Addictive States Research Publications: Assoc. for Research in Nervous and Mental Disease 70:1 (1992) ........................... 63 I - v - 1

I I I I I I I I I I I I I I Tab Jaffe J.H. Critical Issues in Addiction Psychiatry. Speech at the Annual Meeting of the American Academy of Psychiatrists in Alcoholism and Addictions 4 (1991) ...................................... 64 Jaffe J.H. Drug Addiction and Drug Abuse. In: Gilman, Alfred G., et al. (eds.) Goodman and Gilman's the Pharmacological Basis of Therapeutics. 522 (8th ed. 1990) ........................ 65 Jaffe J.H. Tobacco Smoking and Nicotine Dependence. In: Wonnacott S., Russell M.A., Stolerman I.P. (eds.) Nicotine Pharmacology (1st ed. 1990) .............. 66 Jaffe J.H. Trivializing Dependence. Brit J Addict 85(11):1425 (1990) ....................................... 67 Jarvik M., Killen J.D., Varady A., et Favorite Cigarette of the Day. al. J of The Behavioral Med 16(4):413 (1993) .......................... 68 Jarvik M.E. Overview: Alternative Forms of Pharmacologic Treatment. In: Ockene J.K. (ed.) The Pharmacoloaic Treatment of Tobacco Dependence: Proceedings of the World Congress November 4-5. 1985 ....................................... 69 Jarvis M. Any Questions: Is There Any Evidence that Beta Blockers Help People to Give up Smoking? British Med J 36:1513 (1993) ............................. 70 Kenford S.L., Fiore M.C., Jorenby D.E., et al. Predicting Smoking Cessation: Who Will Quit Without the Nicotine Patch. JAMA 271(8):589 (1994) ................................................... 71 Kirk S.A., Kutchins H. The Selling of DSM: The Rhetoric of Science in Psychiatry. (1992) ............... 72 Kleber H.D. The Nosology of Abuse and Dependence. J. Psychiat Res 24(Supp. 2):57-64 (1990) ................. 73 Kozlowski L.T., Wilkinson D.A. Use and Misuse of the Concept of Craving by Alcohol, Tobacco, and Drug Researchers. Br J of Addiction 82:31 (1987) ........ 74 Kozlowski L.T., Herman C.P., Frecker R.C. What Researchers Make of What Cigarette Smokers Say: Filtering Smokers' Hot Air. Lancet 1(8170):699-700 ZND (1986) (self reporting unreliable) ....................... 75 0 Levin E.D., Behm F., Rose J.E. The Use of Flavor p~ in Cigarette Substitutes. Drug and Alcohol W Dependence 26:155 (1990) ................................. 76 CD Oo pO -vi- ~ Oo

I I I I Tab Lombardo T.W., Hughes J.R., Fross J.D. Failure to Support the Validity of the Fagerstrom Tolerance Questionnaire as a Measure of Physiological Tolerance to Nicotine. Addictive Behaviors 13(1):87 (1988) ...................... 77 Lyvers M., Miyata Y. Effects of Cigarette Smoking on Electrodermal Orienting Reflexes to Stimulus Change and Stimulus Significance. Psychophysiology 30:231 (1993) ........................... 78 Marks I. Behavioral (Non-Chemical) Addictions. Brit J Addict 85(11):1389 (1990) ......................... 79 I 1 I I I I ~ I I I I I Mifsud J.C., Hernandez L., Hoebel B.G. Nicotine Infused into the Nucleus Accumbens Increases Synaptic Dopamine as Measured By In Vivo Microdialysis Brain Res 47(2):365-67 (1989) ..................................80 Milkman H., Sunderwirth S. Chemistry of Craving Psychol Today 36-44 (October 1983) ....................... 81 Neuhaus C. The Disease Controversy Revisited: An Ontologic Perspective. J Drug Issues 23(3):463-78 (1993) ......................................82 Nil R. A Psychopharmacological and Psychophysiological Evaluation of Smoking Motives. Rev Env Health 9(2):85 (1991) ........................................... 83 Norregaard J., Tonnesen P., Petersen L. Predictors and Reasons for Relapse in Smoking Cessation With Nicotine and Placebo Patches. Preventative Med 22:261 (1993) ........................... 84 Perkins K.A., Grobe J.E., Stiller R.L., et al. Nasal Spray Nicotine Replacement Suppresses Cigarette Smoking Desire and Behavior. Clinical Pharmacology and Therapeutics 52(6):627 (1992) ......................................... 85 Persico A.M. Predictors of Smoking Cessation In A Sample of Italian Smokers. The International Journal of the Addictions 27(6):683 (1992) ............... 86 Rinaldi R.C., Steindler E.M., Wilford B.B., et al. Clarification and Standardization of Substance Abuse Terminology. JAMA 259(4):555 (1988) ............... 87 - vii -

I I I I I I I I I I I a I I Tab Robinson J.H., Pritchard W.S. The Role of Nicotine in Tobacco Use. Psychoparmacology 108:397-407 (1992) ....... 88 Rosa M., Pacifici R., Altieri I., et al. How the Steady-State Cotinine Concentration In Cigarette Smokers Is Directly Related to Nicotine Intake Clinical Pharmacology Ther 52(3):324 (1992) ......................................... 89 Rose J.E. Transdermal Nicotine as a Strategy for Nicotine Replacement. In: Ockene, J.K. (ed.) The Pharmacologic Treatment of Tobacco Dependence: Proceedings of the World Congress, November 4-5. 1985 (1986) ...................... 90 Rose J.E., Tashkin D.P., Ertle A., et al. Sensory Blockade of Smoking Satisfaction. Pharmacology Biochemistry & Behavior 23:289 (1985) ................................................... 91 Rose J.E., Zinser M.C., Tashkin D.P., et al. Subjective Response to Cigarette Smoking Following Airway Anesthetization. Addictive Behaviors 9:211 (1984) ................................... 92 Rose M.A. Intervention Strategies for Smoking Cessation. Cancer Nursing 14(5):225 (1991) .............. 93 Russell M.A., Jarvis M.J., Feyerabend C., et al. Reduction of Tar, Nicotine and Carbon Monoxide Intake In Low Tar Smokers. Journal of Epidemiology and Community Health 40:80 (1986) ................................................... 94 Russell M.A., Sutton S.R., Iyer R., et al. Long-Term Switching to Low-Tar Low-Nicotine Cigarettes. Brit J of Addiction 77:145 (1982) ........... 95 Rzewnicki R., Forgays D.G. Recidivism and Self-Cure of Smoking and Obesity: An Attempt to Replicate. Am Psychol 42:97 (1987) .................... 96 Schacter S. Recidivism and Self-Cure of Smoking and Obesity. Am Psychol 37:436 (1982) ................... 97 Simon J. Love: Addiction or Road to Self-realization, A Second Look. Am J Psychoanal 42(3):253 (1982) .............................. 98 Tate J.C., Pomerleau C.S., Pomerleau O.F. Pharmacological and Non-pharmocolgical Smoking Motives: A Replication and Extension. Addiction 89:321 (1994) ..................................99 I

I I I 1 I Tab Timmereck T.C. Overcoming the Loss of a Love: Preventing Love Addiction and Promoting Positive Emotional Health. Psychol Rep 66(2):515 (1990) ........................................100 U.S. Department of Health and Human Services. The Health Benefits of Smoking Cessation: A Report of the Surgeon General (1990) ................... 101 U.S. Department of Health and Human Services. The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General (1988) ...... 102 U.S. Department of Health and Human Services, Chronic Obstructive Lung Disease: A Report of the Surgeon General (1984) .............................. 103 I I i I U.S. Department of Health, Education, and Welfare. Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service (1964) ............................ 104 Warburton D.M. Is Nicotine Use an Addiction? The Psychologist 4:166 (1989) ............................... 105 West R.J. Nicotine Pharmacodynamics: Some Unresolved Issues. In: Bock G., Marsh J. (eds.). The Biology of Nicotine Dependence (1990) ...... 106 West R.J., Schneider N. Craving for Cigarettes. British J of Addiction 82:407 (1987) .................... 107 I I I I I I Wetterer A., Von Troschke J. Smoker Motivation -- A Review of Contemporary Literature (1986) .............. 108 Wildmann J., Kruger A., Schmole M., et al. increase of Circulating Beta-Endorphin-Like Immunoreactivity Correlates With the Change in Feeling of Pleasantness After Running. Life Sci 38(11):997 (1986) .............................. 109 Woody G.E., Cottler L.B., Cacciola J. Severity of Dependence: Data From the DSM-IV Field Trials. Addiction 88:1573 (1993) ....................... 110 World Health Organization (WHO). Twentieth Report of the Expert Committee on Drug Dependence. WHO Technical Report Service 551:15-6 (1974) ................111 Zacny J.P., Stitzer M.L. Cigarette Brand-Switching: Italics on Smoke Exposure and Smoking Behavior. J of Pharmacology and Experimental Therapeutics 246(2):619 (1988) ............. 112 I