Smoking remains a leading cause of preventable disease and premature death woridwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illnesses. Nicotine is widely accepted as a necessary constituent in tobacco driving use and dependence. A significant reduction in the nicotine content of cigarettes represents an innovative regulatory strategy with the potential to markedly reduce consumption and lead to greater likelihood of quitting. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. For such a policy to be implemented safely and successfully, a number of critical issues and questions must be evaluated. One primary issue is to determine an appropriately low yield of nicotine content per cigarette that is below the addictive 'threshold'of nicotine, while at the same time balances reduced withdrawal effects and maximizes acceptability. Study 1 directly bears on this issue. Study 1 will assess three different low nicotine yields (0.02, 0.06, 0.18 mg) over a 6-week period and the data generated will be used to select an optimal nicotine yield for the remaining study in Project 1 and for Projects 2 and 3. A second major issue is whether simultaneous nicotine replacement therapy (NRT) facilitates the transition to very low nicotine content (VLNC) cigarettes. Recent evidence suggests that NRT may decrease use of VLNC cigarettes, reduce the volume of smoke inhaled per cigarette, and reduce drop-out rate. Study 2 will compare the effects of VLNC cigarettes in participants on 21 mg transdermal nicotine to another group that smokers VLNC cigarettes while wearing a placebo patch. A third group smoking normal nicotine content cigarettes and wearing placebo patches will be included as an additional control.

Public Health Relevance

This project has two goals. Study 1 will determine the optimal yield for very low nicotine cigarettes that leads to reduced smoking, but also minimal discomfort and maximal acceptability. Study 2 will determine if nicotine replacement aids in the transition to very low nicotine cigarettes. Both studies will advance understanding of the feasibility of using very low nicotine cigarettes to reduce the health burden of smoking.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54DA031659-02
Application #
8379275
Study Section
Special Emphasis Panel (ZDA1-EXL-T)
Project Start
2011-09-15
Project End
2016-08-31
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
2
Fiscal Year
2012
Total Cost
$267,591
Indirect Cost
$87,162
Name
University of Pittsburgh
Department
Type
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Pacek, Lauren R; Vandrey, Ryan; Dermody, Sarah S et al. (2016) Evaluation of a reduced nicotine product standard: Moderating effects of and impact on cannabis use. Drug Alcohol Depend 167:228-32
Perkins, Kenneth A; Kunkle, Nicole; Karelitz, Joshua L et al. (2016) Threshold dose for discrimination of nicotine via cigarette smoking. Psychopharmacology (Berl) 233:2309-17
Smith, Tracy T; Cassidy, Rachel N; Tidey, Jennifer W et al. (2016) Impact of smoking reduced nicotine content cigarettes on sensitivity to cigarette price: Further results from a multi-site clinical trial. Addiction :
von Weymarn, Linda B; Thomson, Nicole M; Donny, Eric C et al. (2016) Quantitation of the Minor Tobacco Alkaloids Nornicotine, Anatabine, and Anabasine in Smokers' Urine by High Throughput Liquid Chromatography-Mass Spectrometry. Chem Res Toxicol 29:390-7
Nardone, Natalie; Donny, Eric C; Hatsukami, Dorothy K et al. (2016) Estimations and predictors of non-compliance in switchers to reduced nicotine content cigarettes. Addiction :
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
Tidey, Jennifer W (2016) A behavioral economic perspective on smoking persistence in serious mental illness. Prev Med 92:31-35
Smith, Tracy T; Rupprecht, Laura E; Cwalina, Samantha N et al. (2016) Effects of Monoamine Oxidase Inhibition on the Reinforcing Properties of Low-Dose Nicotine. Neuropsychopharmacology 41:2335-43
Guillot, Casey R; Stone, Matthew D; Geary, Bree A et al. (2015) Pharmacological, sensorimotor, and expectancy effects on tobacco withdrawal: a preliminary study. Hum Psychopharmacol 30:364-71
Tidey, Jennifer W; Miller, Mollie E (2015) Smoking cessation and reduction in people with chronic mental illness. BMJ 351:h4065

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