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THE EFFECT OF TOBACCO NIICOTINE CONTENT ON CIGARETTE SMOKING BEHAVIOR IN MAN AMER'I C'ANi FEDERAT I'0N FOR CLI N I CAL RES'EAR'CHi SAN'FRANCI'SCO, CALIFORNIA, MAY, 197& (AMI RUB'IN) EP'IDEMIO'LOG'IC ASSOCIATIONS HAVE PMPLICATED'TOBACCO SMOXINIG' A~~S~~ A RISK~~ FACTO'~.R, ~ IN THE~~ DEVELOPMENT O~ff' V'ARIOUS~~ R~~E~SP'~I~RA~~TOR~~Y' AND' CARDIOVASCULAR DISEASES', SOME OF THESE STUDIES HAVE SU!GGESTED. A DOSE-DEPENDENT RELAT I ONSH I P BETWEEN C'ERTA I N DI S'EASES AND' THE DURATION' ANID NUMBER OF CIGARETTES CON~S~~UM'ED~, ASWELL ~ A~S~ WITH INDICATORS OF THE AMOUNT AND DEPTH OF SMOKE INIHALATION,. FOR SOME P'EOP'LE, THE P'H'ARMACOLO'G I C' BAS I S O~F S'MOK I NG' S'EfMS' TO' BE DEPENDENT ON THE NiICOT'INE DELIVERY TO' THE SMOKER. THE QUESTION OF WHETHER O~~R'~ NQT~ NlCOT~INE~ METABO~~LI~TES'~ AR~E~~ ADDICT~INIG, Hq'WEV~E~R,i I'~S~~ STILL DEBATABLE. MOREOVER, SEVERAL INVESTIGATORS HAVE POINTED OUT THAT THERE MAY' BE~ A'N~ I'NCR~EAS~E~ IN HEALTH~~ HAZARDS ~~ TO~HEAVY' SMaKERSWH~O~. SWITCHI FRDM, CIGARETTES CO~~NITA'INII'NGH'~I~GHI TA~R'~ A~~ND'~ NII~~CO'TINE LEVELS TO! C~I GARETTES OF LOW' TAR~ A~~ND'~ N~I C~~OT I NE CONTENT. TH I~~SPO'~TENIT I'AL INCREASED HEALTH HAZARD COULD BE BROUGHT ABOUT BY CHANGES IN SMOKING HA'BITS ANDlALTERATION OF' THE I'~NiD'PV'IDUAL ~S SMOKING PROFILE. T0 Q'UA'N'TI'FY' INDIVIDUAL SMOKING BEHAVIOR WHILE VARY'ING THE NICOTINE CONTENT OF TOBACCO, WE APPLIED UNDER' EXPERIMENTAL CONDITIONS A PREV'IOU'SLY' DEVELOP'ED MAGNETOMETER METHOD OF KO'N0 AND MEA'D', O ~ SCJE 1 MAY WE HAVE THE FIRST SLIDE, PLEASE? T0 STUDY SMOKING' BEHAVIOR, WE MEASURED THE MOVEMENT .J 0 0'.

OF THE R I B CAGE AND ABDOMENI W'I TH' TWO' PAIRS OF ELECTRO' MAGNETO- ~ METERS' PLACED IN OPP'OSI'TI!0'N' ON THE DOR'SAL AND VENTRAL SIDES' OF THE RIB CAGE AND ABD'OMEN. THE RECEIVED SIGNALS WERE LINEARLY RELATED ~~ T0~ THE~ ANTER~~IQR~~-PO~STE~RlO~R DIAMETER MOVEMENTS OF TH~~E~ ~ THORAX ~~ AND~ABDOM'E~N,i ANiD WfRE~ CALI~B~~RATED,TO LUNG VOL.UM~ES',. TH I~ S~: METHOD CAN MEASURE IN A N'0'NINVASIV'E' MANNER THE MOVEMENT OF THE R I B CAGE' flND, ABDOMEN, AND, ASSESS' C'HANGES IN LU'NG' VOLUME DUR I NG BREATHING' WITH ANI ACCURACY OF +101OR' BETTER. OUR CALIBRATION PROCEDURE WAS BASED U!PO'N' THE PERFORMANCE OF INDIVIDUAL ISOVOLUME MANEUVERS AT FUNCTIONAL RE&I'D'UAL CAPAC'DTY~. RIB CAGE AND ABDOMINAL ~ MAGNETOMETER S~~IiGNALS~ WERE~ ADDED ELECTRI CA ' LY' A~~FTERTHEY' hIE'R'E~ ~ ~ EQUALLY ADJUSTED. ~ THE~ RE~SULTI'~NIG' SUM,WAS~ PROPORTIONAL TO~THE~ C'HANIG E I NI LUN'GIV'OLUME, WH I CH WAS MEASURED' S I MULTANEOUS'LY' W'I TH A SP I ROMETER', NEXT SLIDE, PLEAS'E. 1( DE 2 ~ ~ AFTER~ CA~LIB'RA~TIiO'~N',, EACH S~UBJE~CT~ STUDI~ED~ WAS~, S~~EATE~D~ IN SLI'DE 3 A COMFORTABLE CHAIR AND REQUESTED TO SMOKE 01NE OF THE TEST CIGAR'ETTES., THE SUBJECT W'AS' TO'LD1 THAT CERTAINi CARD'I'OPULMONAR'Y' PARAMETERS WERE BEING MEAS'UREDa AND WAS GENERALLY' NOT AWARE THAT HII'S SMOKINGIPATTER'N WAS BEINGiOBSERVED. FOR EACH SUBJECT ANID'. EACH CIGARETTE THE FOLLOWlI'NG MEASUREMENTS WERE MADE: 1) iVIUMBER' OF P'UFfS PER CIGARETTE,l 2) PUFf- I NHALAT I ONI AND EXHALAT I ON VO LUME . 3~ DURATION OF P'UFF' AND TIME OF B'REATHI HO'LDINGI., 4) fR~STING TIDAL VOLUME AND RESPIRATORY FREQUENCY~,l BE~FO~~R'~E~ AND~AFTER'~ SMOKING. COULD W'E' HAVE THE' NEXT S'LI'DE, PLEASE?I!N PR'ELIMINARY' STUDIES WITHi OTHER SUBJE'CTS, WE HAVE EXAMI'NED THE REPR'ODUC'I'BILITY'OF INDIVIDUAL SMOKING PATTERNS OBTAINED ON DIFFERENT DAYS. THIS SLIDE INDICATES THE S'AME.

SUBJ!E~CT~~ OBSERVED UNDER TH~E~ S'AME~~ CO~ND~ I T I ONS ON TWO~~ S'~EPA~RATE' DAYS. THE' TIDAL VOLUME EX'CURS I ONS ARE PLOTTED ON THE VERT ICAL AX'I S,. WITHI THE NUMBER' OF BR'EATHS' ALONG THE HOR'IZONTAL.i CIlGARETTE PUFfS' ARE I'~~NDI~CATED, BY~ THE AS~~TERISKS~., THE TW'0~~ PATTERNS ARE SIMI~~LA~R~ ~ IN'~ FORM. A NUMBER OF STUDIES OF THIS NATURE HAVE INDICATED' THAT THE SUBJE~CT~ REP'EATSTHI&MANNEROF SMOK~I~N'&EACRIT~IME WE OBS'ERV'E' ~ H~IM,., I NOTHERWORDS~~,~~ THE ME~THO!D~,~ AS'~ WELL A'~S'~ THE PATTERN 0'~F~ SMOKI NG~~,~ ARE HIIG'HLY REPRp'D'UC I BLE ., NEXT SLI DE, PLEAS E. SLIDE 4 E'XAMINATIO'N, OF SUBJECTS SM'OKI'NIG THEIR' OWN, COMMERCIAL CIGARETTE BR~~A~~ND, REVEALED FO'~UR, DiI~~S~T lN~CT~ TYP'E~S~ OF~ PATTERNS~~,i AS~, I ND'I CATED ON, THII S SLID'E., WIEH'AVE, I NTHE TOP PA~NEL,THE "DEEP I NH'ALER'S'" WHOSE P'UFF- I'NH'ALATi I 0N VOLUM'E WAS TW0 T0 FOUR T I'MES' THE I R RESTING TIDAL VOLUME. BR'EATH HOLD'IING DUR'ING' THE CIGARETTE PUFF I S I ND'I CATED I N THE SECONDiPANEL, NEXT, AS IIND'IICATED, I S A PATTERN I N WHiI CH EACH P'UFF- I NHALAT I ONlI S FOLLOWED B'Y' A LARG E EXHALATI ON,i ALMOST TO RES IiDUAL VOLUME, WN I C'H WE HAVE CALLED "PURGER'S",I AND SHALLOW I NHA'LERS' ARE I NDI'CATED I N, THE LAST PANEL - NIOTE THAT THE SHALLOW INHALERS HAVE A P'UFF-IN,HALATION VOLUME NOT SIGNIFICANTLY LARGER OR' EVEN PERHAPS SMALLER THAN' THE RESTI'NGi TIDAL VOLUME. NEXT SLID'E., SLIDE g~~ WE~ STUDIED A,GROUP OF 10~~ HIEA~~LTH~~Y~ M'ALE~~ VO~LUNTEERS'~ 2Q-3~5~: ~ YEAR'S OF AGE, WITH A HISTORY' OF TOBACCO CONSUM'PTIONi 0F AT LEAST' 0'~NE~ PACK~~,PER DAY FO'~RFIVE OR': MORE YE~~A~RS., IN~ A~~DD~ITI'~ON, TiH~EY' HAD~w ~ - .~ A NORMAL P'HYSI CAL EXAM I'~ NAT~I ON, AND DETA I LED, P'ULM'O~NARY' F~UNICTI'O~N! EVALUATIONS W'HIC'HI REVEALED N0,SIGNIFICANT' ABNIORM'ALI'TI!ES. ALL O co SUBJECTS WERE ASKED T0 COMPLETE A MO'DIFIED MRC-NIIH QUESTIONNAI'R'E'

AT THE END OF THE S~~TUDY',, ALL SUB~JECTS~~ W~ER~E~ INS TR~UCTEDTO! C REFRAIN FROM SMOKING AFTER 101 P,A, THE PREVIOUS EVENING,~ AND T0 SMO KE THE I R F I RST C I GAR'ETTE O F THE DAY I'N, OUR LABO'RATO RY, OM, NINE DIFFERENT MORNINGS, THE SUBJECTS WERE ASKED TO SMOKE'. EITHER THEIR OWN CIGARETTE, OR CIGARETTES WITH DIFFERENT NICOTINE CONTENT. A'T EACH' SESSION', BLOOD FOR CARBOXYHEMOGLOBIN LEVELS~~ WERE~,MEASURED~ BEFORE AND AFTERSMOK~ING,, WE ARE REPfl~~RTIiNG TODAY' OUR F I ND I NGS R'EGARD IiNG I NDIV'I DUAL ADAPTAT'I ONi T0 LOW' AND. HIGH NICOTINE CO~NTE~NT~ CIGARETTES,~ NEXT SLIDE, P'LEA~~SE,, SLIDE 6 IN,D'I'C'ATED ON THIS' SLIDE I'S THE' CHEMICAL SMO'K'E' ANALYSIS OF' TWO' EXPERIMENTAL CIlGAR'ETTES USED' IN, THI& STUDY, THE HITGH. N I C~OT~I NE C I G~~ARETTE~ I'S~~ A STA~ND'~A~RD'~ RESEARCH C~~I GARETTE WI~TH~~ A TAR'~: AND' NICOTINE DE'LIV'ER'Y' COMPARABLE TO THE HIGHEST LEVELS OF CO'MMERC I ALLY' AV'A I LABLE C I GARETTES TODAY, THE LOW' NiI COT I NE C I GARETTE~~ HAS HAD'~ TH~IE' N I'C'~OT I~NE~ S~~ELECT I VELY~ E~XTRAC'TED~~ BY A,N EWLY' DEVELOPED PRO'CESS, WITHOUT SIGNIFICANTLY ALTERING THE' R'EMAIiNI'NG P'ART I CULATE AND GAS PHASE CQNSTI!TU'ENTS, I N PARTI CULAR, THE LEVELS 0'~F~ C'ERTA~I'N~, GA~S~~ PHASE~ I RRITANTS, A~~CRO~LE I N A~~ND, CARBON MONO'~XI DE, ARE COM'PA'RABLE'BETWEE~N THE TWO! CIGAR~~ETTES,; THE AMOUNT OF NICOTINE PRESENT I'~N' THTS CIGARETTE IS'~ V'~IiRTUA~LL'Y~ NIEG'~LI'~G~~IiBLEp WITH A~, VALUE OF' .025 MG/'C'IIGARETTE, NEXT SLIDE, PLEASE. SLIDE' 7 FOiLLOiW'ING ALL SUBJECTS SMOKING THE HIGHi AND' LO'W' NiICOTI'NE C~~I~GARE~TTE~SBLI'NDLY' 0N SE~PA~~RA'TE' DAYS',, THE FO'~LLO'~WING', DIFFERENCES WE~R~E, OBSERVED: 1)! THERE WAS N0, S I GN I F I CANT' D I'Ff ERENC'E OBSERVED' ~, IN THE AVERAG'E' NUMBER OF PUFFS BETWEEN THE HIGH -J, ' AND, LOW NICOTINE GI'GARETTES, WITH A V'ALUE OF 12.3 a AND113,1. RESPECT'IVELY', w

2) THE MEAN INHALATIONIV'OLUME DURIiNG A CIGARETTE PUFf, ALTHOU'GH DECREASEDi IN THE LOW NICOTINE CIGAR'ETTE, WAS ALSO' NOT SIGNIFICANTLY DIFFERENT FO'R' THE TEN SUBJECTS S!MOKING' EITHER THE HIGH NICOTINE OR LOW NiICOTINE CIGAR'ETTE, WI'THI A VALUE OF 993 ' ML. . AND $30! ML., RESP'fCT1'VE'LY., 3)' THERE WAS, HOWEVER, A SIGNIF'ICANT DIFFERENCE BETWEENI BO'THi CI'GARETTES' I'NI THE TOTAL DURATTON, OF THE IN'HA'LA- T'ION TIME AND BREATH HOLDING DURING THE CIGARETTE P'UFF, WHICH WAS FOUND TO BE"LO'NGER' WHEN SUBJECTS SMOKED LO'WNICO'TIN'E CONTENT CIGAR'ETTES., 4) THE RESPIRATORY FREQUENCY WAS' MONITORED FOR SEVERAL MINUTES BEFORE AND AFTER EACH SUBJECT, AND S'HOWED, A'~ SLIGHT I~NCR~~EASE~ FO~LLOW~I'NG' THE~ SMOKING O~F~ B'OTH' CIGARETTES' I'N THE FIR'ST MINUTE 9, 5) THERE WAS' FOUND TO' BE AN' AVERAGE RISE IN CARBOXY'H'EM0- GLOiB!I'~N' O~~F~ SLI~GHTLY' MO~~RE~ THANi 1% ~~ FRp~~M' TH'~E~~ SMO~K'~lNG OF ONE CIGARETTE OF BOTH THE HIGH AND LOW NICOTINE CIGARETTES. THE INCREASE WA'S NOT STATISTI'CALLY' ~~ D~~IFFERENT'B'ETWEE~NITHE TWO'~ CIGARETTES. ~ MAY' WE HAVE THE NEXT SLIDE, P'LEASE? SLIDE 8 THE INDIVIDUAL BR'EATH HOLDIING TIME DURI,NG PUFFS ON' THE HIGH AND LOW NICbTINiE CIGARETTES' IS' IN'DICATED, ON THIS SLIDE. EIGHT SUBJECTS INCREASED BREATH HO'LDING', TIME WHIEN, SMOKINGILOW' NICOTINE CIGARETTES, WHILE' TWO SUBJECTS DEC'REASED' THIS TIM'E. . 1`JEXT' SLIDE, PLEASf.,

SLIDE~ 9 IN~ CO~NCLUS'~IO~~N,~ WE FEEL~ THAT THESE~ FIND~I NGS~~ SUPPORT THE~ HYPOTHESIS THAT NICOTINE CONTENT OF THE T0'BAC'CO MAY' MODI'FY '~ SMOK'~IiN~G~, B~E~HA~V'IO~~R,: A~ND'~ THAT' IiN OURLIMITED STUDY THE~ SMOKERS MA'Y' TITRATE THEIR NIC'OTINE REG1'UIR'EMENT WHILE SMOKING LOW NIC'OT'INE C I GARETTES BY' K'EE'P I'NG' THE SMOKE IN THE I R LUNGS FOR A LO'NGER. PERIOD OiF' TIME P'OSSIBLYT0 EXTRACT A GREATER AMOUNT OF NICOTI'NE., WHII LE S'OME' OF THE I NCRIEASES OR DECREASES I'NI •DURAT I0'N' OF BREATH HO~LDI NG~~ TIME MAY' HAVE RES~ULTED! FRt?M! ALTERA~~T I~ONS,I NI TASTE AND'~ SATISFACTIONLEV'E'LS IN THE LOW NICOTINE CIGARIETTES, SUCH VARIABLES ARE DlIFFICULT,l IF NOT IMPOSSIBLE, TO GONTROIL. AS A RESULT, COMPAR'IiSONIS WITH COMMERCIAL CIGARETTES INTRODUCE A W'I'DE SPECTRUM! OF UNCONTROLABLE TASTE AND FLAVOR V'ARIABLES'. WE FEEL THAT THE TWO, TOBACCp'C'IGARETTE&USEDIN THE PR'ESENTS'TUD'YP'ROV'IDEDTHE BEST COMPARISON AVAILABLE AT THIS TIME TO' ALTERATION!S' IN, N'ICOTINE DOSI'METRY. IN THE LONG RUNI, THE CHANGES OBSERVED VWTTH THE LOW' NICOTINE CIGARETTE MAY RESULT IN A DIFFERENT DEPOS'ITION'PATTER'N OF THE SMOKE AEROSOL WITHIN THEIR R'ESP'IRATOR'Y SYSTEMi AND' C0'ULD' IiNDI'C'ATE POTENTIAL D'IFFEREN.CE& INi TOBACCO RELATED DISEASE SUSCEPT'IB'ILITY'.

SLIDE I Rib mqc m Tosbl breolh.q / Rcai.er ~ CAUBRATIOK Conventicml I PuGnonanr Fmtion Tests N

SLIDE' 4 PA1 LEIZN'.,7 OF ~ IY~ ~.I.OKING A. `OEEP' INI-~A'LERS" . . ~ ~ ~ ~ ~ ~ . . , Q ,., Gr?EAT"r~ „ HOLDER.S' . * - C.' , ~ Un'GER' ~ '~Ir Z t . ~ ~ !J. SHALLGIV' INHALERS" *Ct . qarette puff SECONDS III

I" SLIDD 5, 5TUDY PQPIJL AT1QN 1,Meal4hy, maie volunteers 20-35 years of age I , •~ 1~~ PP~D~ srrrn~a~~ki,'ng~~ histo~ry~ far~~ 5 ~~ years • No cardiopulmonary diseases • Normal pulmonary function tests . ~.

SLIDE 2' EXP ER l ME l V TAL l I i IEA5' U R EM EN TS er..ci.arette a Puffs P 9 ~ Puff inhalation and exhalation~ volumes w Puff, duration - Breath holding ,oR'esfing tidaf voVme and respiratory freq,uency