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.
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.
|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|
Showing the most recent 10 out of 30 publications