The overarching goal of this center application is to determine how marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers. Reduction in nicotine content has been proposed as a potential regulatory measure to render cigarettes non-addictive and, consequently, to reduce smoke exposure and improve public health. Reducing nicotine content in cigarettes has become a possibility as a result of the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the Food and Drug Administration jurisdiction over tobacco products including the authority to reduce (but not ban) levels of nicotine in cigarettes. The proposed grant with its four inter-related projects, which cross disciplinary boundaries, will help to inform policy decisions. Project 1 includes two human studies evaluating the dose-response relationship for nicotine yield within the range thought to be at or below threshold for dependence and the potential use of concurrent nicotine replacement therapy (NRT) to facilitate the transition to VLNC cigarettes. Project 2 is a multi-site trial assessing the effects of prolonged use of VLNC in a large sample and comparing immediately switching to VLNC cigarettes to gradually reducing the nicotine content in cigarettes over a period of 20 weeks. Project 3 begins to address an important concern about the viability of a new standard for nicotine content in sub-populations (here we focus on smokers with schizophrenia) who might be particularly vulnerable to the effects of reduction in nicotine. Project 4 addresses concerns that the manipulation of other constituents in tobacco could offset the predicted gains of VLNC cigarettes by determining the relationship between the threshold dose for maintaining rat nicotine self-administration and the presence of minor alkaloids, beta-carbolines, acetaldehyde, and MAO inhibitors. The contribution of this Project to the overall center is Crucial. To accomplish these goals, we have proposed an Administrative Core (Core A), a Biomarkers Core (Core B), and a Biostatistics Core (Core C).

Public Health Relevance

The overarching goal of this proposal is to determine whether establishing new standards for cigarettes requiring very low nicotine content would reduce cigarette use and, consequently, reduce the morbidity and mortality associated with smoking. CENTER CHARACTERISTICS

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
1U54DA031659-01
Application #
8151825
Study Section
Special Emphasis Panel (ZDA1-EXL-T (01))
Program Officer
Bough, Kristopher J
Project Start
2011-09-15
Project End
2016-08-31
Budget Start
2011-09-15
Budget End
2012-09-14
Support Year
1
Fiscal Year
2011
Total Cost
$2,537,775
Indirect Cost
Name
University of Pittsburgh
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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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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