Combusted tobacco use continues to devastate public health in the United States and worldwide. The Tobacco Control Act provides the Food and Drug Administration with the authority to establish product standards for the nicotine content of combusted tobacco products. In this renewal application we address a critical question: What will be the impact of reducing nicotine in cigarettes in the context of alternative tobacco products? If reduced nicotine product standards render combusted tobacco products less reinforcing, smokers who choose not to quit using nicotine/tobacco completely will likely increase their use of non- combusted products. This shift from combusted to non-combusted products could greatly reduce toxicant exposure and reduce the harms associated with tobacco. Three Projects and 3 Cores are proposed. Project 1 (PI: Hatsukami) is a 12-week clinical trial that examines the use of very low nicotine content (VLNC) vs. normal nicotine content (NNC) cigarettes when smokers are provided vouchers to exchange for cigarettes in an experimental marketplace that contains a wide range of non-combusted products. Project 2 (PI: Donny) is a 7- week clinical trial comparing VLNC and NNC cigarettes when participants have access to electronic cigarettes that vary in nicotine concentration (high v. low) and available flavors (tobacco only v. tobacco and other flavors). Project 3 (PIs: Colby & Tidey) is a laboratory-based study that assessed the choice to smoke, vape, or abstain when adolescent smokers are provided cigarettes with VLNC v. NNC and e-cigarettes that vary in nicotine concentrations and flavors. The Cores will provide the infrastructure and resources to conduct these studies. The Administrative Core (Directors: Donny & Hatsukami) will ensure the implementation of appropriate procedures and protocols, the integration of methods, measures, and concepts, the communication and dissemination of information, the generation of new tobacco regulatory science through a pilot project program, and the training of new tobacco regulatory scientists. The Biomarkers Core (Director: Hecht) will provide analysis of biomarkers associated with exposure to nicotine and tobacco-related toxicants. The Biostatistics and Data Management Core (Director: Le) will assist in study design, integration and monitoring of data, data analysis, and, when appropriate, the development of novel ways to analyze data.

Public Health Relevance

OVERALL NARRATIVE Product standards that reduce the nicotine content of combusted tobacco products could reduce the devastating public health effects of tobacco by rendering cigarettes and similar products less addictive. This application proposes three projects aimed at determining the impact of reducing nicotine in cigarettes in the context of the availability of non-combusted products that might influence smoking behavior.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
2U54DA031659-06
Application #
9149854
Study Section
Special Emphasis Panel (ZDA1-JXR-G (01)S)
Program Officer
Anderson, Ann
Project Start
2011-09-15
Project End
2022-02-28
Budget Start
2017-03-01
Budget End
2018-02-28
Support Year
6
Fiscal Year
2017
Total Cost
$3,471,615
Indirect Cost
$376,191
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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Tidey, Jennifer W; Miller, Mollie E (2015) Smoking cessation and reduction in people with chronic mental illness. BMJ 351:h4065

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