Evaluating New Nicotine Standards for Cigarettes

总体项目摘要 在美国和全世界，燃烧的烟草使用继续损害公共健康。的 《烟草控制法》规定，食品和药物管理局有权确定产品 燃烧的烟草产品的尼古丁含量标准。在此更新应用程序中，我们解决了 关键问题：在替代品的背景下，减少香烟中的尼古丁会产生什么影响？ 烟草产品？如果降低尼古丁产品标准使燃烧的烟草产品的强化作用降低， 选择不完全戒烟的吸烟者可能会增加非尼古丁/烟草的使用 燃烧的产品。这种从燃烧到非燃烧产品的转变可以大大减少有毒物质 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，研究使用极低尼古丁含量（VLNC）与正常 尼古丁含量（NNC）香烟，当吸烟者获得代金券以换取香烟时， 实验市场，包含各种各样的非燃烧产品。项目2（PI：唐尼）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 不同的尼古丁浓度（高v.低）和可用的口味（烟草只有v.烟草和其他口味）。 项目3（PI：科尔比和Tidey）是一项基于实验室的研究，评估吸烟，vape或弃权的选择 当向青少年吸烟者提供VLNC v. NNC香烟和尼古丁含量不同的电子烟时， 浓度和风味。核心小组将提供进行这些研究的基础设施和资源。 行政核心（董事：Donny和Hatsukami）将确保实施适当的 程序和协议，方法，措施和概念的整合，沟通和 传播信息，通过试点项目方案产生新的烟草监管科学， 以及培训新的烟草监管科学家。生物标志物核心（主任：Hecht）将提供 分析与暴露于尼古丁和烟草相关毒物相关的生物标志物。生物统计 和数据管理核心（负责人：Le）将协助研究设计、数据整合和监测， 分析，并在适当的时候，开发新的方法来分析数据。

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.