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ROYAL OTTAWA HOSPITAL HOPITAL ROYAL D'OTTAWA Dr. V.J. Kno~t, Speciality Clinics. 1145 CARLING, OTTAWA. ONTARIO K1Z 7K4 TEL. 6101722-6521 November 23, 19BI. Canadia.n Tobacco !.:anufacturers Council, 1808 Sherbrooke St. tVest, Montreal, Quebec, H3R IES. Dear CTMC Members, In November of 1979, I proposed that CT~C fundin~ of my research be extended for an additional five year period so that I could further my work on stress-reduction aspects of tobacco smoking. Attached is a copy of the brief proposalz which I considered to be o: critical relevr~nce to the motivational understnnding of the smoking habit. Of ;he projects suggested, the lon~itudinal study ( which involved Year I, Year II and Year V) was considered to be of greatest potential in elucidatin~ motivational mechanisms. Attached is a research proposal which provides, in addition to methodology, the theory, rationale, frzn, ework and significance of this study. Specific details re:-ardinc, details of the methodology have purposely been left out so as to allow the CTMC members a clear scope of the general procedures without distraction by a myriad of detail. If however, specific details of tests, reaarding procedures etc. are required, this can be done on request. Attached also is a list of budget requests and their rationale. My greatest concern and embarrassment here is with ¢he ~moun~ of monies requested an it is the lar6es~ budget (~85,789.00) I have requested to date. The greatest need of cource is technical assistance. I am in the laboratory from 9z00 a.m. - 5:00 p.m. and as such reading, zummarizing and writin~ reports and papers is extremely difficult. An addi~io- • hal member, at the technical level, would definitely relieve the pressure. The rationale lot the additional requests is attached so I will not elaborate here. The large reauesZ of course pertains only Zo Yea," I of the five year plan. The 2nd to ~th year budget request: will be greatly reduced as these will only involve the two salaries and approximately $10,O00/year. .. 1 2 J;.i. O rk9 fyx odd czz) BateD document for PFSFC 1 March 1999

ROYAL OTTAWA HOSPITAL ,,45 ~.,SNG aVE,UE, oTrAwx. ON~'A~,O ~,Z 7K4 . tEU~PHOnE s,3nn.ss2, October 5, 1981 Mr. C. Seymour Executive Secretary Canadian Tobacco Manufacturers Council 1808 Sherbrooke St. West Montreal, Quebec H3H IE5 Dear Mr. Seymour, Enclosed is a brief progress report of my work this (4th) year for Phase III of the research project. The study is still in progress and with luck all subjects should be tested by the end of November. Once the analysis is finished I will assemble the data and findings together for the entire four years and give a formal presentation to C.T.M.C. members in January or February of next year. As mentioned in a previous letter, I am preparing a more detailed account of procedures and budget requests for the coming five year project which is to start this January, 1981. Hopefully this will be ready by November so that a meetin9 can be set up with C.T.M.C. to go over the final details. Sincerely, VJK/nl Verner J. Knott, D. Phil. I l 2/;:.i i ','...L 0 U'I BatCo document for PFSFC 1 March 1999

TOBACCO SMOKING AND STRESS REDUCTION= PHYSIOLOGICAL, BEHAVIORAL AND PSYCHOLOGICAL CORRELATES Dr. V.J. Knott Specialty Clinics, Royal Ottawa Hospital, Ottawa PROGRESS REPORT ON PHASE III: Effects of Brand-Switching on Psychophysiological Reactivity to Induced Stress Submitted to C.T.M.C., Oc~./1981 c~ co CD BatCo document for PFSFC 1 March 1999

TOBACCO SMOKING AND STRESS REDUCTION: PHYSIOLOGICALr BEHAVIORAL AND PSYCHOLOGICAL CORRELATES Dr. V.J. Knott: Specialty Clinics, Royal Ottawa Hospital, Ottawa Progress Report on Phase III: Effects of Brand-Switching oa Psychophysiological Reactivity to Induced Stress. Submitted to C.T.M.C., October, 1981. The initial goal of Phase III, as stated in the research proposal (submitted to C.T.M.C., Aug./77) was to compare the efficacy of the lower tar-nicotine yield cigarettes with experimental cigarettes yielding low tar and moderate to hiqh nicotine on responsivity to induced stress with specific emphasis on smokers who are profiled as being particularly vulnerable and reactive to stress. Although the rationale underlying this phase was well considered and the experimental design and procedures were logically formed, the study was open to major criticism at a practical, feasibility level and at a theoretical, relevant level and these points will be briefly discussed here. The first and most immediate problem focused on the tobacco products which were to be tested. Although low tar-nicotine cigarettes were available from the commercial market, the manufacturing low tar and medium to high nicotine cigarettes posed a serious problem. The "spiking" of low tar-nicotine cigarettes with nicotine citrate in aqueous solution to increase the nicotine yield by up to 30% with no observable changes in smoke pH is technically possible, but spiking beyond this range, an objective of this project, may markedly alter the subjective properties of the cigarette so as to make it unacceptable purely on the basis of taste quality or irritancy. Thus, although technically feasible, the cigare spiked over a 30% nicotine increase would have produced a sulficien~ level of nicotine for desired pharmacological and psychological effects compared to low tar-nicotine cigarettes, but the two cigarette types would also have differed on the additional crucial dimension of taste quality which would have equal if not more influence on smoking parameters as nicotine yield. O pO O~ Co -.j O BatCo document for PFSFC 1 March 1999

The second factor which detracted from the proposed study focussed on the relevance of this particular study design and on experimental brand-switching studies in general. Generalisations from the results of these forced-switching experiments to changes in the habit of the wider population of smokers have to be made with caution. The direct relevance of these studies is reduced because unlike smokers who voluntarily change on the "open market" from a higher to a lower tar-nicotine yield brand in full awareness of the nature of the change, subjects employed in these experiments are either indifferent or ill-disposed towards the brand changes involved. In some respects then, the experimental subjects resemble smokers "pressured" to change to lower yield cigarettes rather than smokers voluntarily and spontaneously changing to lower delivery brands. On this basis, it was decided that a fair assessment of the efficacy of lower tar-nicotine yield brands would require the development of an experimental approach which de-emphasized the impact of "forced-selection" and "unacceptable taste quality" and instead emphasized the role of voluntar~ self-selection of an acceptable lower tar-nicotine yleld brand. For example, it would be of great interest to design a study which would examine a subject sample "self-selected" to determine whether their ~ with cigarettes of reduced delivery is comparaDle with that of other subject groups. With this in mind, Phase III abandoned the original research proposal and restricted itself to more modest and one might say, basic fundamental questions which have direct relevance to brand-switching. Two basic questions guided the framework of this phase: a) are smokers who have successfully (i.e. permanently) switched to lower tar-nicotine yield brands more or less stress reactive (under no-tobacco conditions) than those smokers who have unsuccessfully (i.e. attempted but failed on a permanent basis) switched to a lower tar-nicotine yield brand; b) are smokers who have successfully switched to lower delivery products experiencing more or less stress with their lower delivery product than with their previous higher delivery product. cD c~ c~ o co BatCo document for PFSFC 1 March 1999

As this protocol is a marked departure f.rom that intended and 6escribed in ~he original proposal, a brief description of subjects, design and procedures will follow. A. Subjects. In line with the original intent of Phase III, this " protocol will focus the study on smokers who in general, are profiled as being particularly vulnerable and reactive to stress. As Phase I-B provided empirical evidence that female smokers are on average, more reactive to induced stress as evidenced by physiological hyper-reactivity and decrements in behavioral efficiency, subject selection is restricted to the female smoker population. Criteria for inclusion as a smoker consists of a smoking history of at least one year, a present smoking rate of i0 or mQre. cigarettes/day and reported inhalation of cigarette smoke. Successful Switchers: those who fill the criteria of having attempted and maintained for at least a 3 month period, a switch to a reduced delivery brand with a~ least 30% reduction in tar and nicotine delivery relative to their previous brand. Unsuccessful Switchers: those who fill the criteria of having attempted but failed to maintain for a~ least a 3 month period, a switch to a re'duced delivery brand with at least 30t reduction in tar and nicotine delivery relative to their previous brand. B. Design: Both groups of smokers attend the laboratory on two occasions separated by a one week interval. On each occasion, subjects are tested for stress reactivity during a baseline session and during a subsequent tobacco smoking session. Smoking order of the tobacco products are randomised for each group. Half the successful switchers smoke their current self-selected lower delivery product on the first occasion and their previous higher delivery product on the second occasion. The remaining half smoke their products in the reverse order. A one week acclimatisation period with their previous higher delivery product is required immediately prior to their testing on that product. O ~O cr- oo ~O BatCo document for PFSFC 1 March 1999

Half the unsuccessful switchers smoke their current self- selected higher delivery product on the first testing occasion and a previous self-selected lower delivery product which they had Ettempted but failed to adjust to on the second test occasion. The remaining half smoke their products in the reverse order. A one week acclimatisation period with their attempted lower product is required immediately prior to their testing in that product. All testing takes place during 9:00 A.M. to 12:00 P.M. and stress reactivity is examined in relation to the first cigarette of the day. Puff number and frequency is standardised during both smoking conditions. C. Measures: i As with Phase II, the most direct measure of central nervous system functioning - the electroencephalogram, is monitored as the major variable reflecting stress. The computerized system for assessing brain reactivity will include: (1) period and power spectral profiles of spontaneous brain potentials during behavioral tasks; (2) discrete brain evoked potentials to sensory stimuli during behavioral tasks; (3)slow brain evoked potentials elicited by behavioral tasks of varying complexity. In addition, decision and movement based reaction time measures are monitored asthey proved to be sensitive indicators of stress reactivity in female smokers. Also, in an attempt to monitor smoke absorption with the various various cigarette products and in order to determine the relationship between stress reactivity and modifications in smoking absorption with the cigarette products, carbon monoxide concentrations in alveolar breath are sampled during each smoking condition using an Ecolyser. On concluding, one may be rightly justified in posing the question of whether this type of study which monitors psycho- physiological components and motivational mechanisms in brand- switching is warranted or can be justified at all. The answer must be "yes" for the current yardsticks available for measuring success in providing a low risk product are smoke chem/stry screening and the results of bio-testing in animals, based on standard smoking parameters. What is largely overlooked is that smokers modify smoking parameters and that these modifica- tions are intrinsically related to the most common reasons smokers give for accounting for their smoking-namely to reduce nervous tension, stress and to provide relaxation. In the r~D c~ cSD BatCo document for PFSFC 1 March 1999

5 final.analysis then, measurement procedures'and yardsticks for judging the relative success of low risk factors of low tar products must incorporate the human response at psychological, physiological and behavioral levels and they must make allowance for the assessmen~ of these response systems in relation to motivational processes with specific reference to stress reduction. cD r~D co BatCo document for PFSFC 1 March 1999