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。它还有权根据烟草产品科学咨询委员会的建议，禁止香烟中的薄荷醇。本研究的目的是检查这两种监管措施单独和联合在女性薄荷醇吸烟者中的潜在影响。这一系列调查回应了FDA建议的研究领域，包括1）薄荷醇对烟草产品吸引力的潜在影响和戒烟的影响？2)尼古丁的减少是如何影响消费者戒烟的感觉和能力的？3)对香料和味道敏感性的遗传变异如何影响烟草成瘾？4)薄荷醇和尼古丁含量降低的香烟（RNC）对育龄妇女等弱势人群有何影响？我们提出了一个2x 2设计，其中320名非寻求治疗的女性薄荷醇吸烟者将被随机转换为尼古丁含量降低的香烟（RNC），尼古丁含量降低的薄荷醇香烟（RNC-Men），传统尼古丁非薄荷醇香烟（CN），或自己品牌的传统尼古丁-薄荷醇香烟（CN-Men），为期6周，额外随访6周。我们将研究降低尼古丁含量和/或从香烟中去除薄荷醇对女性薄荷醇吸烟者吸烟行为、尼古丁依赖和戒烟措施的影响。我们假设，女性薄荷醇吸烟者随机分配到任何修改内容的香烟（CN，RNC，RNC-Men）将每天吸烟更少的香烟相比，在CN-男性条件。我们还将研究这些香烟内容操作的毒性暴露的措施的影响，检查机制，内容操作可能会减少吸烟行为（通过检查措施，反映操作的灭绝和厌恶条件反射过程），并探讨味觉受体基因的遗传变异的调节作用对切换到实验香烟的反应。

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.