Decades of research suggest nicotine is the primary psychoactive constituent of tobacco that results in dependence. Consistent with this extensive literature and their regulatory authority to reduce (but not eliminate) nicotine, the Food and Drug Administration has identified nicotine products standards that target the appeal and addictiveness of cigarettes as a top research priority. Evidence to date suggests that smokers who are switched to reduced nicotine cigarettes reduce the number of cigarettes they smoke, reduce their exposure to nicotine and toxicants, and report less cigarette dependence. However, the implications of these observations are complicated by the fact that few smokers actually quit smoking and most supplement their use of reduced nicotine cigarettes with commercially available, non-study cigarettes that contain normal amounts of nicotine. If normal nicotine content cigarettes were largely unavailable as a result of regulation, many smokers may turn to alternative products, particularly e-cigarettes. The degree to which e-cigarettes facilitate further reductions in smoking, or cessation, will likely depend on characteristics of e-cigarettes that impact their reinforcing effects relative to conventional cigarettes. In particular, both nicotine concentration and availability of a variety of flavors may affect the degree to which e-cigarettes substitute for cigarettes. Consequently, Project 2 examines how three factors ? the nicotine content of cigarettes, the nicotine concentration of e-cigarettes, and the availability of both tobacco and non-tobacco flavors of e-cigarettes interact to determine whether current smokers reduce or stop smoking. Participants (N=480) at two sites will be randomized in a 2x2x2 design to receive A) cigarettes with 0.4 mg/g vs. 15.8 mg/g nicotine; B) e-cigarettes in tobacco only vs. tobacco and non-tobacco flavors; and C) e-cigarettes with 2 vs. 18 mg/ml nicotine. For 7 weeks, participants will be given a full supply of both cigarettes and e-cigarettes. During the last week, participants will be given monetary incentives to abstain from smoking tobacco. Equal numbers of younger (18-24) v. older (25+) and male v. female smokers will be recruited. We hypothesize that reducing nicotine in cigarettes will reduce cigarettes smoked, cigarette dependence, and exposure to toxicants while increasing use of e-cigarettes and the ability to abstain from smoking. We further predict that these effects will be greater when participants are provided e-cigarettes with higher nicotine concentration and both tobacco and non-tobacco flavors. We will also test the impact of condition on the subjective effects of each product and explore whether the behavioral and subjective effects vary as a function of age and gender. In summary, the proposed study will provide the Food and Drug Administration with critically important information directly related to potential products standards for the nicotine content of combusted tobacco. The results will determine how reducing nicotine in cigarettes impacts tobacco product use and effects when e-cigarettes with different characteristics are available as alternatives. 0925-0001/0002 (Rev. 08/12) Page Continuation Format Page

Public Health Relevance

This project will examine how three factors ? the nicotine content of cigarettes, the nicotine concentration of e-cigarettes, and the availability of both tobacco and non-tobacco flavors of e-cigarettes interact to determine whether current smokers reduce or stop smoking. We will compare the number of cigarettes smoked, cigarette dependence, use of e-cigarettes, biomarkers of toxicant exposure and days abstinent from cigarettes. The results of this study would contribute to policy decisions on whether or not nicotine levels should be regulated in cigarettes.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
7U54DA031659-07
Application #
9442735
Study Section
Special Emphasis Panel (ZDA1)
Project Start
Project End
Budget Start
2018-04-01
Budget End
2019-02-28
Support Year
7
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Tidey, Jennifer W; Davis, Danielle R; Miller, Mollie E et al. (2018) Modeling nicotine regulation: A review of studies in smokers with mental health conditions. Prev Med 117:30-37
Ho, Yen-Yi; Nhu Vo, Tien; Chu, Haitao et al. (2018) A Bayesian hierarchical model for demand curve analysis. Stat Methods Med Res 27:2038-2049
Streck, Joanna M; Bergeria, Cecilia L; Parker, Maria A et al. (2018) Response to reduced nicotine content cigarettes among smokers with chronic health conditions. Prev Med Rep 12:321-329
Pacek, Lauren R; Joseph McClernon, F; Denlinger-Apte, Rachel L et al. (2018) Perceived nicotine content of reduced nicotine content cigarettes is a correlate of perceived health risks. Tob Control 27:420-426
Cassidy, Rachel N; Tidey, Jennifer W; Cao, Qing et al. (2018) Age Moderates Smokers' Subjective Response to Very Low Nicotine Content Cigarettes: Evidence from a Randomized Controlled Trial. Nicotine Tob Res :
Villanti, Andrea C; Gaalema, Diann E; Tidey, Jennifer W et al. (2018) Co-occurring vulnerabilities and menthol use in U.S. young adult cigarette smokers: Findings from Wave 1 of the PATH Study, 2013-2014. Prev Med 117:43-51
Pericot-Valverde, Irene; Elliott, Rebecca J; Miller, Mollie E et al. (2018) Posttraumatic stress disorder and tobacco use: A systematic review and meta-analysis. Addict Behav 84:238-247
Denlinger-Apte, Rachel L; Tidey, Jennifer W; Koopmeiners, Joseph S et al. (2018) Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes. Tob Control :
Parker, Maria A; Streck, Joanna M; Bergeria, Cecilia L et al. (2018) Reduced Nicotine Content Cigarettes and Cannabis Use in Vulnerable Populations. Tob Regul Sci 4:84-91
Kazi, Abid; Fazzi, Alyse; Krebs, Nicolle M et al. (2018) Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research. Contemp Clin Trials Commun 11:69-74

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