Evaluating New Nicotine Standards for Cigarettes

整体项目总结 燃烧的烟草使用继续破坏美国和世界各地的公共健康。这个 《烟草控制法》赋予食品和药物管理局制定产品的权力 燃烧烟草制品中尼古丁含量标准。在此续订申请中，我们针对的是 关键问题：在替代方案的背景下，减少香烟中的尼古丁将产生什么影响 烟草产品？如果降低的尼古丁产品标准使燃烧的烟草产品的强度降低， 选择不完全戒烟的吸烟者可能会增加他们对非尼古丁/烟草的使用 烧毁的产品。这种从燃烧产品到非燃烧产品的转变可以大大减少有毒物质。 并减少与烟草相关的危害。提出了三个项目和三个核心。项目1 (PI：Hatsukami)是一项为期12周的临床试验，考察了极低尼古丁含量(VLNC)与正常尼古丁含量的使用情况 尼古丁含量(NNC)香烟向吸烟者提供换取香烟的代金券 包含多种非燃烧产品的试验性市场。项目2(PI：Donny)是一个7- 当参与者可以使用电子烟时，比较VLNC和NNC香烟的一周临床试验 尼古丁浓度(高对低)和有效口味(仅烟草对烟草和其他口味)的不同。 项目3(PI：Colby&Tidey)是一项以实验室为基础的研究，评估了吸烟、吸电子烟或戒烟的选择 当向青少年吸烟者提供VLNC诉NNC和尼古丁含量不同的电子烟时 浓度和味道。这些核心将提供进行这些研究的基础设施和资源。 行政核心(主任：Donny&Hatsukami)将确保执行适当的 程序和协议，方法、措施和概念的集成，通信和 传播信息，通过试点项目方案产生新的烟草管制科学， 以及培训新的烟草监管科学家。Biomarkers Core(董事：Hecht)将提供 与尼古丁和烟草相关毒物接触相关的生物标志物分析。生物统计学 数据管理核心(主任：LE)将协助研究设计、集成和监测数据、数据 分析，并在适当的时候，开发新的数据分析方法。

OVERALL PROJECT SUMMARY Combusted tobacco use continues to devastate public health in the United States and worldwide. The Tobacco Control Act provides the Food and Drug Administration with the authority to establish product standards for the nicotine content of combusted tobacco products. In this renewal application we address a critical question: What will be the impact of reducing nicotine in cigarettes in the context of alternative tobacco products? If reduced nicotine product standards render combusted tobacco products less reinforcing, smokers who choose not to quit using nicotine/tobacco completely will likely increase their use of non- combusted products. This shift from combusted to non-combusted products could greatly reduce toxicant exposure and reduce the harms associated with tobacco. Three Projects and 3 Cores are proposed. Project 1 (PI: Hatsukami) is a 12-week clinical trial that examines the use of very low nicotine content (VLNC) vs. normal nicotine content (NNC) cigarettes when smokers are provided vouchers to exchange for cigarettes in an experimental marketplace that contains a wide range of non-combusted products. Project 2 (PI: Donny) is a 7- week clinical trial comparing VLNC and NNC cigarettes when participants have access to electronic cigarettes that vary in nicotine concentration (high v. low) and available flavors (tobacco only v. tobacco and other flavors). Project 3 (PIs: Colby & Tidey) is a laboratory-based study that assessed the choice to smoke, vape, or abstain when adolescent smokers are provided cigarettes with VLNC v. NNC and e-cigarettes that vary in nicotine concentrations and flavors. The Cores will provide the infrastructure and resources to conduct these studies. The Administrative Core (Directors: Donny & Hatsukami) will ensure the implementation of appropriate procedures and protocols, the integration of methods, measures, and concepts, the communication and dissemination of information, the generation of new tobacco regulatory science through a pilot project program, and the training of new tobacco regulatory scientists. The Biomarkers Core (Director: Hecht) will provide analysis of biomarkers associated with exposure to nicotine and tobacco-related toxicants. The Biostatistics and Data Management Core (Director: Le) will assist in study design, integration and monitoring of data, data analysis, and, when appropriate, the development of novel ways to analyze data.