Manipulating Tobacco Constituents in Female Menthol Smokers

描述：FDA有权减少但不能消除香烟中的尼古丁。根据烟草产品科学咨询委员会的建议，它还有权禁止香烟中的薄荷醇。这项研究的目的是检查这两种监管行动单独和联合对女性薄荷醇吸烟者的潜在影响。这一系列调查回应了FDA提出的研究领域，包括1)薄荷醇对烟草产品吸引力的潜在影响以及戒烟的影响；2)尼古丁的减少如何影响消费者的感知和戒烟能力？3)对调味品和口味的敏感性的遗传变异如何影响烟草成瘾？4)在育龄妇女等弱势群体中，薄荷醇和尼古丁含量降低(RNC)有什么影响？我们提出了2×2设计，其中320名未接受治疗的女性薄荷醇吸烟者将被随机分成四组，分别改用低尼古丁含量香烟(RNC)、低尼古丁含量薄荷醇香烟(RNC-Men)、传统尼古丁非薄荷醇香烟(CN)或其自有品牌的传统尼古丁-薄荷醇香烟(CN-Men)，为期六周，并进行额外的六周随访。我们将研究减少尼古丁含量和/或从香烟中移除薄荷醇对女性薄荷醇吸烟者吸烟行为、尼古丁依赖和戒烟的影响。我们假设，随机选择任何一种修改内容香烟(CN、RNC、RNC-Men)的女性薄荷醇吸烟者，与CN-Men条件下的女性吸烟者相比，每天抽的香烟会更少。我们还将研究这些卷烟成分操纵对毒物暴露指标的影响，研究内容操纵可能减少吸烟行为的机制(通过检查反映消退和厌恶条件反射过程的措施)，并探索味觉受体基因的遗传变异对切换到实验香烟的反应的调节作用。

DESCRIPTION: 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.