Manipulating Tobacco Constituents in Female Menthol Smokers
Principal Investigator: Cheryl Oncken
Funding Mechanism: National Institutes of Health- Grant
ID number: 1R01DA036486-01
Award Date: 9/30/2013
Institution: University of Connecticut Health Center
The FDA has the regulatory authority to reduce nicotine levels and ban menthol in cigarettes, but has yet to take either of these actions. Available evidence suggests that women are more sensitive to the non-nicotine aspects of smoking (such as taste and smell) and may have a harder time quitting than men. The purpose of this study is to examine the effects of reducing nicotine content and/or removing menthol from cigarettes on measures of smoking behavior, nicotine dependence and cigarette abstinence in 320 female menthol smokers aged 18 and older. Investigators will examine the effects and safety of these two possible regulatory actions alone and in combination by randomizing subjects to one of four alternatives: reduced nicotine content (0.07 mg) cigarettes without menthol; reduced nicotine content (0.07 mg) menthol cigarettes; conventional nicotine cigarettes without menthol; or own brand (conventional nicotine menthol cigarettes). Specific aims are: (1) to examine the effects of reducing nicotine content and/or removing menthol from cigarettes on measures of smoking behavior, nicotine dependence and abstinence; (2) to examine the effects of reducing nicotine content and/or removing menthol from cigarettes on measures of toxicant exposure (e.g, cotinine, exhaled carbon monoxide, and urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL]) and other tobacco-specific nitrosamines; (3) to examine the mechanisms by which cigarette content manipulations may decrease smoking behavior in female menthol cigarette smokers; and (4) to explore the moderating effect of “supertaster status” (i.e., the tendency to experience flavors and irritation with far greater intensity than average) on tolerability of experimental cigarettes, smoking satisfaction, and smoking behavior. This study will provide new information about the impact of menthol and reduced nicotine content cigarettes in this vulnerable population.