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

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Specialized Center--Cooperative Agreements (U54)
Project #
Application #
Study Section
Special Emphasis Panel (ZDA1-EXL-T (01))
Program Officer
Walton, Kevin
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Pittsburgh
Schools of Arts and Sciences
United States
Zip Code
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

Showing the most recent 10 out of 63 publications