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PSU TCORS: Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety Disorders

Principal Investigator: Jonathan Foulds and Eden Evins

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036107-01

Award Date: 9/30/2013

Institution: Pennsylvania State University, Harvard 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. This randomized controlled trial will evaluate the effect of progressive cigarette nicotine reduction on smoking behavior, toxin exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Specific aims include: (1) to assess the effect of switching to gradually reduced nicotine content cigarettes on product use patterns and biomarkers of exposure in smokers with mood and/or anxiety disorders; (2) to assess the effect of switching to gradually reduced nicotine content cigarettes on psychiatric and nicotine withdrawal symptoms in smokers with unipolar mood and/or anxiety disorders; and (3) to assess the effect of switching to gradually reduced nicotine content cigarettes on self-perception of tobacco dependence, self-report of intention to quit smoking, and actual smoking cessation attempts. Investigators will randomly assign 200 adult smokers with a unipolar mood and/or anxiety disorder to smoke research cigarettes containing either usual nicotine content (similar to their usual brand) or reduced nicotine content (progressively reduced from approximately 11 mg to 0.3 mg over five steps). This study is designed to test the hypotheses that nicotine intake, as measured by plasma cotinine concentrations, will decline as a function of cigarette nicotine content, and that reducing the nicotine content of the cigarettes on a gradual basis will minimize potential compensatory increases in tobacco exposure biomarkers and psychiatric symptoms compared to the usual brand group. This study will provide empirical data that could inform regulatory actions related to reducing cigarette nicotine content.


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