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 #
3U54DA031659-02S1
Application #
8650430
Study Section
Special Emphasis Panel (ZDA1-EXL-T (01))
Program Officer
Walton, Kevin
Project Start
2011-09-15
Project End
2016-08-31
Budget Start
2012-09-15
Budget End
2013-08-31
Support Year
2
Fiscal Year
2013
Total Cost
$3,072,358
Indirect Cost
$254,815
Name
University of Pittsburgh
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Hatsukami, Dorothy K; Donny, Eric C; Koopmeiners, Joseph S et al. (2015) Compensatory smoking from gradual and immediate reduction in cigarette nicotine content. Cancer Epidemiol Biomarkers Prev 24:472-6
Vogel, Rachel Isaksson; Hertsgaard, Louise A; Dermody, Sarah S et al. (2014) Sex differences in response to reduced nicotine content cigarettes. Addict Behav 39:1197-204
Tidey, Jennifer W; Colby, Suzanne M; Xavier, Emily M H (2014) Effects of smoking abstinence on cigarette craving, nicotine withdrawal, and nicotine reinforcement in smokers with and without schizophrenia. Nicotine Tob Res 16:326-34
Smith, Tracy T; Schassburger, Rachel L; Buffalari, Deanne M et al. (2014) Low-dose nicotine self-administration is reduced in adult male rats naïve to high doses of nicotine: implications for nicotine product standards. Exp Clin Psychopharmacol 22:453-9
Dermody, Sarah S; Donny, Eric C (2014) The predicted impact of reducing the nicotine content in cigarettes on alcohol use. Nicotine Tob Res 16:1033-44
Donny, Eric C; Hatsukami, Dorothy K; Benowitz, Neal L et al. (2014) Reduced nicotine product standards for combustible tobacco: building an empirical basis for effective regulation. Prev Med 68:17-22
Hatsukami, Dorothy K; Heishman, Stephen J; Vogel, Rachel Isaksson et al. (2013) Dose-response effects of spectrum research cigarettes. Nicotine Tob Res 15:1113-21
Hatsukami, Dorothy K; Benowitz, Neal L; Donny, Eric et al. (2013) Nicotine reduction: strategic research plan. Nicotine Tob Res 15:1003-13
Hatsukami, Dorothy K; Hertsgaard, Louise A; Vogel, Rachel I et al. (2013) Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev 22:1015-24
Tidey, Jennifer W; Rohsenow, Damaris J; Kaplan, Gary B et al. (2013) Separate and combined effects of very low nicotine cigarettes and nicotine replacement in smokers with schizophrenia and controls. Nicotine Tob Res 15:121-9

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