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Mouth-Level Nicotine Intake Estimates from Discarded Filter Butts to Examine Compensatory Smoking in Low Nicotine Cigarettes Tracy T

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Mouth-Level Nicotine Intake Estimates from Discarded Filter Butts to Examine Compensatory Smoking in Low Nicotine Cigarettes Tracy T Published OnlineFirst February 26, 2020; DOI: 10.1158/1055-9965.EPI-19-0905 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION | RESEARCH ARTICLE Mouth-Level Nicotine Intake Estimates from Discarded Filter Butts to Examine Compensatory Smoking in Low Nicotine Cigarettes Tracy T. Smith1, Joseph S. Koopmeiners2, Dorothy K. Hatsukami3, Katelyn M. Tessier4, Neal L. Benowitz5, Sharon E. Murphy6, Andrew A. Strasser7, Jennifer W. Tidey8, Benjamin C. Blount9, Liza Valentin9, Roberto Bravo Cardenas9, Clifford Watson9, James L. Pirkle9, and Eric C. Donny10 ABSTRACT ◥ Background: A mandated reduction in the nicotine content the proportion of nicotine per cigarette recovered through of cigarettes could reduce smoking rate and prevalence. changes in smoking intensity. However, one concern is that smokers may compensate by Results: There was no significant increase in smoking intensity increasing the intensity with which they smoke each cigarette for any of the reduced nicotine cigarettes as measured by the to obtain more nicotine. This study assessed whether smokers compensation index (an estimated 0.4% of the nicotine lost engage in compensatory smoking by estimating the mouth-level was recovered in the lowest nicotine group; 95% confidence interval, nicotine intake of low nicotine cigarettes smoked during a À0.1 to 1.2). There was a significant decrease in smoking intensity clinical trial. for very low nicotine content cigarettes with increased tar yield. Methods: Smokers were randomly assigned to receive cigar- Conclusions: Reductions in nicotine content did not result in ettes with one of five nicotine contents for 6 weeks. An additional compensatory changes in how intensively participants smoked group received a cigarette with the lowest nicotine content, but an research cigarettes. increased tar yield. The obtained mouth-level nicotine intake from Impact: Combined with data from clinical trials showing a discarded cigarette butts for a subset of participants (51–70/ reduction in cigarettes smoked per day, these data suggest that a group) was estimated using solanesol as described previously. reduction in nicotine content is unlikely to result in increased smoke A compensation index was calculated for each group to estimate exposure. Introduction encouraging—showing that a reduction in nicotine content in con- ventional cigarettes to 0.4 mg nicotine/g tobacco results in participants The FDA is considering a mandated reduction in the nicotine smoking fewer cigarettes per day, lower levels of nicotine dependence, content of cigarettes to a minimally addictive or nonaddictive level (1). more quit attempts, and greater smoking cessation (3–5). A recent simulation estimated that a nicotine reduction policy imple- However, one of the primary concerns regarding potential harms of mented by 2020 would save 1.7 million lives by the year 2050 (2). a nicotine reduction policy has been the potential for compensation to Clinical trials surrounding nicotine reduction thus far have been mitigate the reduced nicotine content (6). Compensation can take place via an increase in the number of cigarettes smoked per day or 1Department of Psychiatry and Behavioral Sciences, and Hollings Cancer Center, increase in intensity of smoking each cigarette (i.e., changes in smoking Medical University of South Carolina, Charleston, South Carolina. 2Division of topography such as taking “larger” or more frequent puffs). Some of Biostatistics, School of Public Health, and Masonic Cancer Center, University of these concerns stem from an analogy to “light” cigarettes. Switching Minnesota, Minneapolis, Minnesota. 3Department of Psychiatry and Masonic from regular to light cigarettes does result in compensatory smoking, Cancer Center, University of Minnesota, Minneapolis, Minnesota. 4Masonic 5 driven primarily by an increase in intensity of smoking each ciga- Cancer Center, University of Minnesota, Minneapolis, Minnesota. Departments rette (7). Light cigarettes have the same nicotine content as full flavored of Medicine and Bioengineering & Therapeutic Sciences, University of California, San Francisco, San Francisco, California. 6Department of Biochemistry Molecular cigarettes, but yield reduced nicotine via changes in the design of the Biology and BioPhysics and Masonic Cancer Center, University of Minnesota, cigarette (e.g., ventilated filters) under standardized smoking machine Minneapolis, Minnesota. 7Department of Psychiatry, Perelman School of Med- testing. However, smokers achieve much higher exposures than pre- icine, and Abraham Cancer Center, University of Pennsylvania, Philadelphia, dicted by machine via compensatory smoking practices (8, 9). 8 Pennsylvania. Department of Behavioral and Social Sciences, Brown University, In contrast, a nicotine reduction policy would reduce the nicotine 9 Providence, Rhode Island. Division of Laboratory Sciences, National Center for content within the tobacco itself. In clinical trials, there is no evidence Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia. 10Department of Physiology and Pharmacology, Wake Forest School of that compensation occurs through increases in the number of cigar- Medicine, Winston-Salem, North Carolina. ettes smoked per day. When cigarette nicotine content is reduced to very low levels (<2.4 mg nicotine/g tobacco), participants smoke fewer, Note: Supplementary data for this article are available at Cancer Epidemiology, – Biomarkers & Prevention Online (http://cebp.aacrjournals.org/). not more, cigarettes per day (3 5, 10). Until now, the best evidence regarding the impact of nicotine reduction on changes in smoking Corresponding Author: Tracy T. Smith, Medical University of South Carolina, 103D Bioengineering Building, 68 President Street, Charleston, SC 29425. intensity within each cigarette have come from laboratory-based puff Phone: 843-792-5164; Fax: 843-876-2344; E-mail: [email protected] topography assessments (11, 12), in which the total puff volume of each cigarette was measured by requiring participants to smoke research Cancer Epidemiol Biomarkers Prev 2020;29:1–7 cigarettes through a machine that quantifies smoking behavior (e.g., doi: 10.1158/1055-9965.EPI-19-0905 number of puffs, volume of each puff, and time between puffs). Ó2020 American Association for Cancer Research. Laboratory-based puff topography assessments have shown that when AACRJournals.org | OF1 Downloaded from cebp.aacrjournals.org on September 24, 2021. © 2020 American Association for Cancer Research. Published OnlineFirst February 26, 2020; DOI: 10.1158/1055-9965.EPI-19-0905 Smith et al. nicotine content is reduced to low levels, there are increases in puff nicotine content; one received a cigarette with the same machine- volume across the first few cigarettes (11, 12), but decreases in puff measured tar level as the other groups [8–10 mg International Stan- volume after extended use with the cigarettes (3). In-line with these dards Organization (ISO)], and one group received a cigarette with an data showing a lack of compensation when smokers switch to low increased tar yield [high tar (HT), 13 mg ISO]. For research cigarette nicotine cigarettes, clinical trials show that assignment to receive very groups, nicotine content was double blind. All cigarettes were provided low nicotine content (VLNC) cigarettes results in reduced biomarkers for free. Participants were asked not to smoke cigarettes other than of exposure to smoke and tobacco toxicants (3–5). the research cigarettes but were encouraged to be honest if they The goal of this study was to assess whether smokers assigned to used nonstudy cigarettes. Across all 6 weeks of study assessment, receive cigarettes with a reduced nicotine content engage in compen- participants reported the number of study and nonstudy cigarettes satory smoking by changing their smoking intensity (i.e., changing smoked per day using an automated interactive voice-response system how they smoke each cigarette to obtain more nicotine than expected). (InterVision Media). Participants returned to the laboratory each week We used a novel approach that assessed changes in smoking intensity during the experimental period to complete assessments and receive for cigarettes smoked outside of the laboratory during the clinical trial more cigarettes. A 2-week supply of cigarettes was provided at each by analyzing the cigarette butts of these cigarettes. As part of a recent weekly visit to allow for the measurement of compensatory increases in clinical trial, smokers were randomly assigned to receive research smoking rate or to prevent participants from running out of cigarettes cigarettes with varying nicotine contents for 6 weeks. During weeks 2 if they missed a visit. and 6, participants collected and returned a sample of their discarded At baseline, week 2, and week 6, participants were asked to collect cigarette butts. A subset of these butts was used to measure solanesol. their discarded cigarette butts from the 24-hours prior to their first Solanesol is a long-chain terpenoid that is naturally occurring in void urine on the day of their scheduled visit. For the purpose of this tobacco and is deposited in the filter when the cigarette is smoked, analysis, we focus on week 6 as the timepoint most representative of serving as a useful marker for smoke exposure. Solanesol levels in butts stable smoking behavior (baseline and week 2 not shown). Parti- can be used to estimate the obtained mouth level of nicotine intake cipants were provided with individual metal tins for collecting
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