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Therapeutic Areas: Psychiatry/Psychology | Family Medicine
Disease Category: Substance Abuse
Location: United States, NJ
Clinical Trial Details
Research Study Summary
The Effect of Menthol on Nicotine Levels and Metabolites in African American Cigarette Smokers .
Menthol is an important cigarette additive to study because of its influence on smoking behavior and carcinogenesis and higher use in African American (AA) cigarette smokers. Socioeconomic status (SES) is a critical potential confounder to include since poorer smokers likely alter their cigarette puffing to economize and maximize nicotine intake per cigarette. In this proposal, we will examine serum levels of nicotine and its metabolites in 75 African Americans who smoke menthol vs. 75 African Americans who smoke non-menthol cigarette and have varying levels of SES. We hypothesize that menthol smokers will have increased nicotine intake per cigarette, compared with non-menthol smokers and that this effect will be most pronounced in individuals with low SES. Since menthol may also effect nicotine metabolism, we will also characterize the rate of oxidative and alternative nicotine metabolism through examining ratios of oxidative and glucuronidative metabolites. This study improves on prior studies of nicotine and metabolites by including consideration of SES and adding analyses of alternative nicotine metabolic pathways (i.e. glucuronidation).
Patient Inclusion Criteria: Adult (>18 years of age) AA smokers will be invited to participate in the study if they are daily smokers of 10 or more cigarettes per day (cpd).
Patient Exclusion Criteria: We will exclude subjects who are on concomitant NRT (nicotine gum, patch, inhaler, nasal spray, lozenge), clonidine, bupropion, nortriptyline or other FDA approved treatments for tobacco dependence which may be available at the time of the study. We will also exclude subjects who are using tobacco products other than cigarettes. We will also exclude any pregnant smokers or those planning to become pregnant in the next 1 month since pregnancy has been associated with accelerated metabolism of nicotine and cotinine .
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Both Male and Female
Date Last Changed:
July 23, 2013
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