Evaluating New Nicotine Standards for Cigarettes

描述（由申请人提供）：本中心申请的总体目标是确定香烟中尼古丁含量的显著减少如何影响当前吸烟者对烟草的使用和影响。减少尼古丁含量已被提议作为一项潜在的管制措施，以使香烟不会上瘾，从而减少吸烟和改善公众健康。减少香烟中的尼古丁含量已成为可能，因为通过了《家庭吸烟预防和烟草控制法案》（FSPTCA），该法案赋予食品药品监督管理局（Food and Drug Administration）对烟草产品的管辖权，包括减少（但不是禁止）香烟中的尼古丁含量的权力。拟议的补助金及其四个相互关联的跨学科项目将有助于为政策决定提供信息。项目1包括两项人体研究，评估尼古丁产量在被认为等于或低于依赖阈值的范围内的剂量-反应关系，以及同时使用尼古丁替代疗法（NRT）促进向VLNC香烟过渡的可能性。项目2是一项多地点试验，评估在大样本中长期使用VLNC的影响，并比较在20周内立即切换到VLNC香烟与逐渐减少香烟中的尼古丁含量。项目3开始解决一个重要的问题，即在亚人群中制定尼古丁含量新标准的可行性（这里我们关注的是患有精神分裂症的吸烟者），他们可能特别容易受到尼古丁减少的影响。项目4通过确定维持大鼠尼古丁自我给药的阈值剂量与微量生物碱、-碳碱、乙醛和MAO抑制剂之间的关系，解决了对烟草中其他成分的操纵可能抵消VLNC香烟预期收益的担忧。这个项目对整个中心的贡献是至关重要的。为了实现这些目标，我们提出了行政核心（核心A），生物标志物核心（核心B）和生物统计学核心（核心C）。

DESCRIPTION (provided by applicant): The overarching goal of this center application is to determine how marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers. Reduction in nicotine content has been proposed as a potential regulatory measure to render cigarettes non-addictive and, consequently, to reduce smoke exposure and improve public health. Reducing nicotine content in cigarettes has become a possibility as a result of the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the Food and Drug Administration jurisdiction over tobacco products including the authority to reduce (but not ban) levels of nicotine in cigarettes. The proposed grant with its four inter-related projects, which cross disciplinary boundaries, will help to inform policy decisions. Project 1 includes two human studies evaluating the dose-response relationship for nicotine yield within the range thought to be at or below threshold for dependence and the potential use of concurrent nicotine replacement therapy (NRT) to facilitate the transition to VLNC cigarettes. Project 2 is a multi-site trial assessing the effects of prolonged use of VLNC in a large sample and comparing immediately switching to VLNC cigarettes to gradually reducing the nicotine content in cigarettes over a period of 20 weeks. Project 3 begins to address an important concern about the viability of a new standard for nicotine content in sub-populations (here we focus on smokers with schizophrenia) who might be particularly vulnerable to the effects of reduction in nicotine. Project 4 addresses concerns that the manipulation of other constituents in tobacco could offset the predicted gains of VLNC cigarettes by determining the relationship between the threshold dose for maintaining rat nicotine self-administration and the presence of minor alkaloids, beta-carbolines, acetaldehyde, and MAO inhibitors. The contribution of this Project to the overall center is Crucial. To accomplish these goals, we have proposed an Administrative Core (Core A), a Biomarkers Core (Core B), and a Biostatistics Core (Core C). PUBLIC HEALTH RELEVANCE: The overarching goal of this proposal is to determine whether establishing new standards for cigarettes requiring very low nicotine content would reduce cigarette use and, consequently, reduce the morbidity and mortality associated with smoking. CENTER CHARACTERISTICS