The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. It also has the authority to ban menthol from cigarettes, as has been recommended by the Tobacco Products Scientific Advisory Committee. The purpose of this study is to examine the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This line of inquiry responds to FDA suggested areas for research including 1) What are the potential effects of menthol on appeal of tobacco products and the impact of cessation?;2) How do reductions in nicotine influence consumer perceptions and ability to quit tobacco?;3) How does genetic variation in sensitivity to flavorings and taste influence tobacco addiction?;4) What is the impact of menthol and reduced nicotine content cigarettes (RNC) in a vulnerable population such as women of reproductive age? We propose a 2x 2 design in which 320 non-treatment seeking female menthol smokers will be randomized to switch to reduced nicotine content cigarettes (RNC), reduced nicotine content menthol cigarettes (RNC-Men), conventional nicotine non-menthol cigarettes (CN), or to conventional nicotine-menthol cigarettes of their own brand (CN-Men), for six weeks with an additional six week follow-up. We will examine the effects of reducing nicotine content and/or removing menthol from cigarettes on measures of smoking behavior, nicotine dependence and cigarette abstinence in female menthol smokers. We hypothesize that female menthol smokers randomized to any of the modified content cigarettes (CN, RNC, RNC-Men) will smoke fewer cigarettes per day compared to those in the CN-Men conditions. We will also examine the effects of these cigarette content manipulations on measures of toxicant exposure, examine mechanisms by which content manipulations may decrease smoking behavior (by examining measures that reflect operation of extinction and aversive conditioning processes), and explore the moderating effect of genetic variation in taste receptor genes on response to switching to experimental cigarettes.
The FDA has the authority to reduce the nicotine content and/or eliminate menthol from cigarettes. The current study examines the potential effect of these potential regulatory actions (either alone or in combination) on smoking behavior in female menthol smokers.
