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PSU TCORS: Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers with Lower Socioeconomic Status

Principal Investigator: Joshua Muscat and Jonathan Foulds

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036107-01

Award Date: 9/30/2013

Institution: Pennsylvania State University

A potential strategy to reduce harm from tobacco is reducing nicotine content and delivery to non-addictive levels. The effectiveness of this strategy needs to be demonstrated in different populations whose response to reduced nicotine content (RNC) cigarettes might be substantially mediated by personal or environmental factors. To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic status (SES) populations, investigators will test the following specific aims: (1) to determine the effect of progressive nicotine content reduction on biological levels of nicotine, its metabolites, and other biomarkers of smoking exposure; (2) to determine the predictors of participant drop-out/relapse; and (3) to determine if a gradual reduction in nicotine content versus same nicotine content is associated with a reduction in stress. This randomized double-blinded controlled trial will evaluate nicotine intake in 400 adult smokers with lower socioeconomic status who switch to progressively reduced nicotine content test cigarettes. Investigators will randomize smokers to either an RNC group with a gradual step-wise reduction in nicotine from 11 mg to 0.3 mg per cigarette in five stages, or a control group with nicotine content that approximates that of their usual cigarette brand. Test nicotine research cigarettes will be obtained through the National Institute on Drug Abuse (NIDA) Drug Supply Program (part of the National Institutes of Health). The RNC group will include menthol and non-menthol flavors. Additional measures will include changes in psychological scales and biomarkers of stress. This study will provide empirical data that could inform regulatory actions related to reducing cigarette nicotine content.

Pennsylvania State University Tobacco Center of Regulatory Science (TCORS) Related Resources

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