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r I I I I I I I I I I I I I I I I D-,-ug ard Alcokol Dependence. 26 (1990)155-160 155 :,'Isevier Scientific Publishers Ireland Ltd. The use of flavor in cigarette substitutes Edward D. Levin, Frederique Behm and Jed E. Rose •Nicotine Research Laboratory, VA Medical Center, Durham, NC and Department of PsyeAiatry, Duke Univeriity, DurAcm, NC RI.S.A.I flteceived February 1st,1990) Cigarette smokers identify flavor as an important factor in the pleasure derived from smoking and for their choice of ciga- rette brand. The issue of cigarette flavor has received a great deal of study by cigarette manufacturers but relatively little by academic investigators. The paucity of literature is particularly acute in terms of the importance of flavor in cigarette substi- tutes. which are used to help people to reduce or quit smoking. In the current study, five different types of flavors added to a plastic cigarette substitute were assessed in experienced smokers. There were two menthol-like flavors and three tobacco-like flavors. Two groups of smokers were tested: menthol smokers and "regular" (non-menthol) smokers. Both types of smokers liked the two menthol flavors signifieantly more than placebo and rated the menthol flavors and the cigarette flavor as signifi- cantly more satisfying than placebo. Craving was differentially reduced in the two groups of smokers. Menthol smokers showed a small reduction in craving with the placebo. with a significant enhancement of this reduction seen with the addition of the "EZ Quit" menthol flavor. Key words: fLvor•, cigarette substitutes; tobaceo: cfgarettes: smoking; smoking eessation: menthol Introduction The importance of flavor in cigarette smok- ing is evidenced by the effort and expense that tobacco companies invest in analyzing, develop- ing and Ydvertising the different flavors of their cigarettes. For example, one of the most widely known cigarette advertising slogans in recent times is "Winston tastes good like (sic) a cigarette rhould". Cigarette smokers identify a wide variety of flavor and aroma components as important in the pleasure they derive from smoking (Reasor, Reynolds and Ferris, 1988). However, in contrast to cigarettes, little research has been conducted concerning the importance of flavor in cigarette substitutes that may be employed in smoking cessation programs. Since the flavor of cigarettes is so important to smokers, it seems reasonable that Correspondence to: Edward D. Levin. Nicotine Research Laboratory (151). VA Medical Center, 508 Fulton St.. Dur- ham, NC 27705. U.S.A. the flavor of cigarette substitutes would be important as well. Developing proper flavors for cigarette substitutes might help their effi- cacy for aiding the reduction and cessation of cigarette smoking. As with cigarettes, there is probably no sin- gle flavor that is preferred by all individuals using a cigarette substitute. The most pro- nounced difference in the flavors between ciga- rette brands exists between the mentholated and "regular" (i.e„ non-mentholated) brands. In the present study, cigarette substitutes using five different flavors were assessed by experi- enced smokers of either menthol or regular cigarette brands. The chemosensory cues provided by ciga- rette smoke as it passes through the upper respiratory tract on its way to the lungs may become important for the reinforcing effects of cigarette smoking (Ashton and Stepney, 1982; Cain, 1980, Stepney, 1984). We have found that the sensory stimuli accompanying cigarette smoking are crucial in providing much of the 0376-8716190/t03.50 ® 1990 Elsevier Scientific Publishers Ireland Ltd. Printed and Published in Ireland

I I I I I I I I I I I I I I I I I I 158 immediate satisfaction gained from smoking. Especially important is the tracheal "throat scratch" provided by cigarette smoke (Cain, 1980, Rose, 1988; Rose et al., 1984; Rose et al., 1985). A cigarette substitute which provides a throat scratch effectively reduces craving and is rated as more satisfying by smokers than one that does not (Rose and Hickman, 1987). The present study was conducted to determine whether the addition of flavor to cigarette sub- stitutes would also enhance the degree of satis- faction and craving reduction they provide. Methods Subjects Twenty-five experienced smokers (20 male, 5 female) recruited by newspaper advertise- ments in the Los Angeles area were the sub- jects in the present study. Thirteen smoked "regular" (non-mentholated) cigarettes while 12 smoked menthol cigarettes. Their average age was 37.7 years (range 21-65) and they had been smoking cigarettes regularly for an aver- age of 17.3 years (range 5-50). They smoked an average of 26.6 cigarettes per day (range 20- 45) with an average nicotine delivery of 1.02 mg (range 0.61-1.14) as determined by the stand- ard FTC method. There were no significant dif- ferences in these smoking characteristics between the groups of regular and menthol smokers. Procedure The subjects participated in the study between 0900 h and 1230 h after undergoing overnight deprivation of cigarettes. The sub- jects were given placebo cigarettes made of a hollow plastic tube with a flavor capsule loaded inside (Fig. 1). Five different flavors and a pla- cebo (no flavor) were used. Three of the flavors were tobacco-like and two were menthol-like. The added flavors were: the smoke residue from a mechanically smoked cigarette (Pall Mall) and two natural liquid flavor mixtures often added to tobacco, "T77" flavor (Type T 7739) and "Virginia" flavor (Type 77696-74), both made by Givaudan Inc. (Clifton. NJ). The Dr1M MI• I ilwor C&OSUI• 1CCm noutnota, FSa.1. A diagram of the plastic smoking substitute devic liquid flavors were added to cigarette filter inserted into the plastic cigarette substituta The device used was identical in all condition only the flavor differed. The cigarette smok residue was adsorbed to the surface of tb chamber by passing smoke from one cigarett through it. The menthol flavors used were th cartridges used in two commercial smokin cessation products: EZ-Quit (Tarzana, CA) an Paipo (Tokyo, Japan). One of the major constiti ents in these products was menthol, but the also contained mint and other flavors. In repeated measures design, each of the subject was given the six flavors, one at a time, for k' min each in a counterbalanced order in one da: They were told to try each of the substitutes b puffing on it when they received it and to co: tinue to use it ad libitum for the next half hour After testing each device the subjects wer asked to fill out a questionnaire to rate it o seven point scales ranging from very definitel not (1) to very definitely (7). The question were: "Did it reduce your craving for a cigarette?" "Did you like it?" "Was it satisfying?" "Did you puff on it more than you would hav puffed on a cigarette?" "Would it help you to quit smoking?" After testing all of the devices the subject were asked to rank them from the most to leas favorite. Data analysis The subject ratings were evaluated by mixed design analyses of variance for betwee

I 157 I I I I I I I I I I I I I I I I A and within subjects measures. The between subjects factor was menthol vs. non-menthol (regular) smokers and the within subjects fac- tor was the cigarette substitute flavor condi- tion Significant interactions were followed-up by tests of the simple main effects of flavor within each group to determine the source of theinteraction (Keppe1,1973). To further evalu- ate significant flavor effects, planned compari- sons using the Bonferroni correction for alpha slippage (Neter, 1985) were made for each of the flavor conditions with the placebo condi- tion. Results Liking There .vas a significant main effect of flavor (F (5,115) = 7.07, P< 0.001). However the main effect of group and the group x flavor interac- tion were not significant. As shown in Fig. 2, significant increases in liking were seen only with the EZ Quit (P< 0.05) and Paipo (P< 0.05) conditions compared with placebo. The three tobacco flavors were not found to be effective with this measure. .Sattif.ZCt10R There was a significant main effect of flavor (F(5, 115) =' 6.84, P < 0.001). No significant effects were seen with the main effect of group or the group x flavor interaction. As shown in Fig. 3, significant increases in satisfaction were seen with EZ Quit (P < 0.01), Paipo (P < 0.05) and the cigarette flavor (P < 0.01). Liking $.o 7 .01 t 01 ZA~ t.0 . Qo y T O ~wwa o OS +s pqn0o Ner Ezo0 r.e V.N. r 77 cyr.r Fig.2. The effect of flavor condition on "liking" ratings by regular (N : 13l and menthol W: 12) groups (mean s S.E.M.). s.o 40 30 to 1A 0.0 Satistaction ftar aaa h,. v.Wr i 77 ciw.r • p < 0.06 .. pac.ee '• p < 0.01 n paa0o Fi;. 3. The effect of flavor condition on "satisfaction" rat• ings by regular W= 13) and menthol W= 121 groups (mean t S.E.M.). Craving reduction There was a significant overall effect of fla- vor on craving reduction (F(5, 115) = 3.16, P< 0.01). There was no significant main effect of group. The group x flavor interaction was sig- nificant (F (5,115) = 2.99, P < 0.025). Different flavors added to the cigarette substitute improved the craving reduction for the regular group versus menthol group (Fig. 4). As a fol- low-up statistical analysis to determine the Craving Reduction, Regular Smokers t M H Z Prese. EZQW Paeo Vr9mm r 77 Cpar.,M Craving Reduction, Menthol Smokars t 'o<o05npiqb PYSee f20w Pap VMqMU T 77 CMU.u. F'ig. 4. The effect of flavor condition on "craving reduc• tion" ratings by regular W a 13) and menthol W= 12) groups (mean t S.E.M.). (a) Craving reduction in the regu- lu group. (b) Craving reduction in the menthol group. I

I I I I I I I I I I I I I I I I I I 158 source of the significant interaction, tests of the simple main effect of flavor condition within each group were conducted. With the regular group this test did not detect a significant over- all effect of flavor condition. With the menthol group there was a significant effect of flavor condition (F (5, 55) = 4.59, P < 0.005). Individ- ual contrasts of means within the menthol group showed that the EZ-Quit flavor provided significantly greater craving reduction com- pared with placebo (P < 0.05). Marginally sig- nificant enhancements of craving reduction were seen with the Paipo (P < 0.07) and ciga- rette smoke (P < 0.06) flavors compared with placebo. One principal difference between the two types of smokers is that the unflavored placebo cigarette caused a moderate decrease in craving in the regular group and only a small decrease in craving in the menthol group. Puffing There was a significant main effect of flavor on the question "Would you puff on this more than a cigarette?" (F (5, 115) = 5,115) = 2.32, P < 0.05). The main effect of group and the group x flavor interaction were not significant. The only significant specific contrast was between the placebo and the T77 flavor. The smokers reported significantly less puffing on the T77 flavored device than the placebo (P < 0.05). Quitting 'No significant effects of group or flavor were seen for the question "Would this device be useful in quitting?" The mean response for the placebo device was 3.4 ± 0.4. The mean respon- ses for the different flavor conditions varied around the score for the placebo with the Vir- ginia flavor receiving the low score of 3.0 t 0.3 and the cigarette smoke flavor receiving the high score of 4.0 t 0.4. Ranking There was a significant main effect for rank• ing (F (5, 120) = 3.64, P < 0.005). The mean ranks given each condition is shown in Table I. In general, for both regular and menthol smoh• ers the Virginia and T77 flavors were ranked near or below the placebo, while the cigarette smoke, EZ-Quit and Paipo flavors were ranked above the placebo. Discussion These results provide initial evidence co* cerning the importance of flavor in cigarette substitutes. Interesting data were gathere~ not only concerning the effects of different fla- vors but also the differential iatings in some cases by smokers of mentholated and non-men• tholated cigarettes. For most of the ineasures the menthol and "regular" groups appeared to regard the differ• ent flavor conditions in the same way. The addi• tion of the two flavors containing menthol (EZ• Quit and Paipo) to the cigarette substitute improved its ratings in terms of liking and sat- isfaction. The cigarette flavor provided improved rating of the substitute in terms of satisfaction only. The two commercial tobacco flavor additives ("T77" and "Virginia" flavors) were not found to enhance the rating of the cig- arette substitute. These tobacco additives may have been ineffective because they were devel oped to complement the flavor of burning tobacco which was not present in the cigarette Table 1. Ranking of the different flavor conditions by regular (N = 13) and menthol (N = 12) groups (mean m S.E HJ. Group Flavor conditions Placebo EZ-Quit Paipo Virginia T77 Cigarette Re;ular 32s0.4 42t0.5 4.4s0.5 2.7 s 0.4 3.1 s 0.5 3.4 = 0.4 Menthol 3.5s0.4 3.7*0.6 4.5s0.5 3.0s0.5 22s0.4 41s0.4 ~ 0

I I I I I I I I A I I I I I I I substitute. The two menthol flavors were the highest rated of the flavors in the current study. This may have been due to the presence of menthol in these flavors or to the fact that they were complex flavor mixtures developed as commercial smoking cessation aids. How- ever,', the significant increase in satisfaction provided by the cigarette flavor demonstrated that it was not necessary to add menthol flavor or to use a commercially developed smoking cessation aid to enhance the satisfaction provided by the cigarette substitute. There were differential effects of the flavor conditions in smokers of mentholated vs. non- mentholated cigarettes with regard to craving reduction. With the regular group there was no significant effect of flavor condition on craving reduction. With the menthol group signifr cantly enhanced craving reduction was seen with the EZ-Quit flavor and marginally signifi- cant trends toward reduced craving were seen with the Paipo flavor and the cigarette smoke flavor. One of the principal differences was that the regular smokers showed a moderate degree of craving reduction with the unflavored device while the menthol group did not. These results suggest that Lnenthol smokers pay more attention to the presence of flavor for craving reduction than "regular" smokers, for whom handling and puffing on the unflrvored device seemed to provide a moderate degree of relief. In this study the subjects were permitted to use each device on an ad libitum basis. While this design did allow for unequal use of each device, all subjects tried puffizg on all of the devices. The ad lib use of the cigarette substi- tutes provided a good approximation of how these devices would be used in a natural set- ting. These results indicate that the addition of flavors, particularly menthol and mint flavors. can increase the acceptability of cigarette sub- stitutes and increase their efficacy in relieving craving during smoking withdrawal. It is inter- esting that the menthol flavors were found to be favored even by smokers of non-mentho- lated cigarettes. Although not tested in the current study, it is possible that the cooling 159 sensation in the mouth and throat provided by the menthol may have provided an acceptable substitute for the tracheal stimulation that has been found to be critical for cigarette satisfaa tion (Cain, 1980; Rose, 1988; Rose et al., 1984; Rose et a1..1985). Although no significant differences between flavors were obtained in response to the ques- tion "Would this device be helpful in quitting?", the subject sample studied here was not trying to quit smoking. Data from individuals attempt- ing to quit smoking would be more helpful in answering this question. It is interesting that despite the lack of significant effect of flavor on the helpfulness question, there were significant effects on Iflcing, satisfaction and craving reduc- tion. Clearly, more research is needed in this area. One crucial need is a better understanding of the importance of flavor in cigarette smoking and in substitutes designed to aid smoking ces- sation. Knowledge of the role of conditioned and perhaps unconditioned effects of sensory stimulation in smoking will facilitate the devel- opment of more effective smoking substitutes. Aclmowledgements This study was supported by a grant from E- Z Quit, Inc. and by the Medical Research Ser- vice of the Veterans Administration. The authors wish to thank Carla Adivi for her help with the study. References Asbton. H. and Stepney, R. (1982) Smoking Psychology and Pharnucology. Tavistock Publications, New York. Cain. W.S. (1980) Sensory attributes to cigarette smoking. In: Banbury Report 3: A Safe Cigarette? (Gori. G.B. and Bock. F.G. eds.), p. 239. Cold Spring Harbor Laboratory, New York. Keppel. G. (1973) Design and Analysis: A Researcher's Handbook. Prentice-HaIl. Inc.. Englewood Cliffs. NJ. Neter. J.W. and Kutner, M.H. (1985) Applied Linear Statist- ical Models. 2nd. ed. Richard E. Irwin. Inc« Homewood. IL. Reasor, B.A. et aL (1983) Sensory assessment of tobacco smoke. Rec. Adv. Tobacco Sci.14. 3. Rose. J.E. (1988) The role of upper airway stimulation in smoking. In: Nicotine Repkcement: A Critical Evalua- I

I I I I I I I I Ll I I I I I I I I I I 160 tion (Pomerieau. O.F. and Pomerleau. C.S., eds.), p. 95, Alan R. Liss, New York. Raae, J.E. and Hickman, C. (1987) Citric scid aerosol as a potential smoking cessation aid. Chest 92.1005 Rose, J.E. et al. (1984) Subjective response to cigarette smoking following airway anesthetiution. Addict. Behav. 9,211. Rose, J.E. et al. (198b) Sensory blockade of smoking satiafa-eT- tion. Pharmacol. Biochem. Behav. 23,289. 4Stepney, R. (1984) Suman smoking behavior and the deval:,- opment of dependence on tobacco smoking. In: Nicatin.; and the Tobacco Smoking Habit (Balfour, D.I.K., ed.1, p;' 153, Pergamon Press. New York. "