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 #
2U54DA031659-06
Application #
9149859
Study Section
Special Emphasis Panel (ZDA1-JXR-G (01)S)
Project Start
Project End
Budget Start
2017-03-01
Budget End
2018-02-28
Support Year
6
Fiscal Year
2017
Total Cost
$685,514
Indirect Cost
$129,885
Name
University of Pittsburgh
Department
Type
Domestic Higher Education
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Smith, Tracy T; Cassidy, Rachel N; Tidey, Jennifer W et al. (2017) Impact of smoking reduced nicotine content cigarettes on sensitivity to cigarette price: further results from a multi-site clinical trial. Addiction 112:349-359
Miller, Mollie E; Tidey, Jennifer W; Rohsenow, Damaris J et al. (2017) Electronic Cigarette Expectancies in Smokers with Psychological Distress. Tob Regul Sci 3:108-114
Rupprecht, Laura E; Koopmeiners, Joseph S; Dermody, Sarah S et al. (2017) Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. Tob Control 26:e43-e48
Murphy, Sharon E; Sipe, Christopher J; Choi, Kwangsoo et al. (2017) Low Cotinine Glucuronidation Results in Higher Serum and Saliva Cotinine in African American Compared to White Smokers. Cancer Epidemiol Biomarkers Prev 26:1093-1099
Mercincavage, Melissa; Wileyto, E Paul; Saddleson, Megan L et al. (2017) Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards. Addiction 112:1095-1103
Benowitz, Neal L; Donny, Eric C; Hatsukami, Dorothy K (2017) Reduced nicotine content cigarettes, e-cigarettes and the cigarette end game. Addiction 112:6-7
Smith, Tracy T; Rupprecht, Laura E; Sved, Alan F et al. (2016) Characterizing the relationship between increases in the cost of nicotine and decreases in nicotine content in adult male rats: implications for tobacco regulation. Psychopharmacology (Berl) 233:3953-3964
Tidey, Jennifer W; Cassidy, Rachel N; Miller, Mollie E et al. (2016) Behavioral Economic Laboratory Research in Tobacco Regulatory Science. Tob Regul Sci 2:440-451
Dermody, Sarah S; Tidey, Jennifer W; Denlinger, Rachel L et al. (2016) The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use. Alcohol Clin Exp Res 40:606-15
Rupprecht, Laura E; Smith, Tracy T; Donny, Eric C et al. (2016) Self-Administered Nicotine Suppresses Body Weight Gain Independent of Food Intake in Male Rats. Nicotine Tob Res 18:1869-1876

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