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). We are currently recruiting only African American non-menthol smokers for this study. The study has already recruited menthol cigarette smokers.

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).
We are currently recruiting only African American non-menthol smokers for this study. The study has already recruited menthol cigarette smokers.

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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CW ID: 165171
Date Last Changed: July 23, 2013

Clinical Trial Snapshot

Both Male and Female
18 and up
Overall Status
Facility Type


Kunal K. Gandhi, Instructor
Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School
317 George Street, Suite # 105
New Brunswick, NJ 08901
Phone: 732) 235-9711
Fax: (732) 235-4277

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