Evaluating New Nicotine Standards for Cigarettes

描述(由申请人提供)：该中心申请的首要目标是确定卷烟尼古丁含量的显著减少如何影响当前吸烟者的烟草使用和影响。减少尼古丁含量已被提议作为一项潜在的监管措施，使香烟不会上瘾，从而减少吸烟暴露和改善公众健康。由于《家庭吸烟预防和烟草控制法》(FSPTCA)的通过，减少香烟中的尼古丁含量成为可能，该法案赋予食品和药物管理局对烟草产品的管辖权，包括降低(但不是禁止)香烟中尼古丁含量的权力。拟议的赠款及其四个相互关联的项目跨越了学科界限，将有助于为政策决策提供信息。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)以促进向VLNC香烟过渡的可能性。项目2是一项多地点试验，在大样本中评估长期使用VLNC的效果，并将立即改用VLNC香烟与在20周内逐步减少香烟中的尼古丁含量进行比较。项目3开始解决一个重要的问题，即新的尼古丁含量标准在可能特别容易受到尼古丁减少影响的亚群(这里我们关注的是患有精神分裂症的吸烟者)中的可行性。项目4通过确定维持大鼠尼古丁自我给药的阈值剂量与存在少量生物碱、β-卡波林、乙醛和MAO抑制剂之间的关系，解决了人们对烟草中其他成分的操纵可能抵消VLNC香烟的预期收益的担忧。这个项目对整个中心的贡献至关重要。为了实现这些目标，我们提出了一个管理核心(核心A)、一个生物标记核心(核心B)和一个生物统计核心(核心C)。 与公共健康相关：这项提案的首要目标是确定为尼古丁含量极低的香烟制定新标准是否会减少香烟的使用，从而降低与吸烟有关的发病率和死亡率。 中心特征

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