Manipulating Tobacco Constituents in Female Menthol Smokers

描述：美国食品和药物管理局有权减少香烟中的尼古丁，但不能完全消除。根据烟草产品科学咨询委员会的建议，它也有权禁止在香烟中添加薄荷醇。本研究的目的是检查这两种调节作用单独或联合对女性薄荷醇吸烟者的潜在影响。这条调查线回应了FDA建议的研究领域，包括1)薄荷醇对烟草制品的吸引力和戒烟的影响有什么潜在影响？2)尼古丁含量的降低如何影响消费者的认知和戒烟能力？3)对香料和味觉敏感性的遗传变异如何影响烟草成瘾？4)薄荷醇和低尼古丁含量香烟（RNC）对弱势人群（如育龄妇女）的影响是什么？我们提出了一个2x - 2设计，其中320名寻求非治疗的女性薄荷吸烟者将被随机分配到低尼古丁含量香烟（RNC）、低尼古丁含量薄荷香烟（RNC- men）、传统尼古丁非薄荷香烟（CN）或传统的自有品牌尼古丁薄荷香烟（CN- men），为期六周，并进行另外六周的随访。我们将研究减少尼古丁含量和/或从香烟中去除薄荷醇对女性薄荷醇吸烟者吸烟行为、尼古丁依赖和戒烟的影响。我们假设，女性薄荷吸烟者随机分到任何一种改良成分香烟（CN、RNC、RNC- men）中，每天的吸烟量会比CN- men组少。我们还将研究这些香烟含量操纵对有毒物质暴露测量的影响，研究内容操纵可能减少吸烟行为的机制（通过检查反映灭绝和厌恶调节过程操作的测量），并探索味觉受体基因遗传变异对转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.