Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers

项目摘要。黑人/非裔美国人（AA）的烟草相关癌症发病率最高， 任何种族/族裔群体的死亡率。超过70%的AA吸烟者吸薄荷醇作为他们通常的品牌， 相比之下，白色吸烟者只有20%。薄荷味是唯一允许在香烟中使用的特征性香料， 目前的联邦法规，薄荷醇的使用与发展到既定的吸烟有关， 更难戒掉。关于电子尼古丁输送系统影响的证据（ENDS， 也就是说，电子烟）表明这些产品可能是香烟的危害较小的替代品。很少有人 研究了ENDS摄取如何影响AA吸烟者的烟草使用和相关毒性，特别是 抽薄荷烟的人最近，FDA开始监管像JUUL这样的封闭系统设备， 占据了70%以上的ENDS市场，并为青少年ENDS使用的急剧增加做出了贡献。作为早期 2020，除薄荷醇/烟草外的调味ENDS盒（用作ENDS一部分的小型封闭单元） 在美国被禁止。然而，为了实现其公共卫生使命，FDA必须平衡限制获取 结束口味，吸引年轻人的需要的证据"是否和如何某些口味可能有助于 成年吸烟者减少吸烟，转而使用潜在危害较小的产品”（FDA，2018）。 了解ENDS在公平减少燃烧烟草使用的公共卫生负担方面的潜力 需要有针对性的研究来预测未来的ENDS风味法规将如何影响AA薄荷醇吸烟者。 目前的研究将评估ENDS薄荷醇香料的可用性是否影响烟草使用的措施， 通过在AA薄荷醇吸烟者（N = 210）中进行一项研究， 3组、平行组、为期6周的ENDS提供临床试验，随访至30天。JUUL器械， 我们的团队已经广泛评估了5%尼古丁的兼容墨盒。个研究组 将因FDA对ENDS风味可用性的潜在规定而不同：1）目前市场上只有薄荷醇 和烟草味ENDS盒是可用的; 2）只有烟草味是可用的市场，以及3） 一个只有无味墨盒的市场。从随机化前1周开始，每周进行一次研究访视 在整个过程中进行每日烟草使用监测，并在每次每周访视时收集生物标志物/自我报告数据。 AA薄荷醇吸烟者受到烟草产品的不成比例的伤害， 健康受益于监管良好的ENDS的增加。这项工作的结果将有助于FDA 关于从目前的监管市场转向对AA薄荷醇吸烟者的影响的预测， 从以薄荷为基础的ENDS，其中薄荷醇和烟草是可用的，到一个只有烟草或没有香料的地方， available.这些问题的答案将涉及FDA在行为、毒性和成瘾方面的优先事项， 提供关于FDA对薄荷醇香料ENDS的潜在监管行动的后果的新数据， 有助于最大限度地提高健康促进作用，并最大限度地减少AA薄荷醇吸烟者的意外后果。

PROJECT SUMMARY. Black/African Americans (AA) have the highest tobacco-related cancer incidence and mortality rates of any racial/ethnic group. Over 70% of AA smokers smoke menthol as their usual brand, compared to 20% for White smokers. Menthol is the only characterizing flavor allowed in cigarettes under current federal regulations, and menthol use is associated with progression to established cigarette smoking as well as more difficulty quitting. Evidence regarding the effects of electronic nicotine delivery systems (ENDS, i.e., e-cigarettes) suggests these products may be a less harmful alternative to cigarettes. Little work has examined how ENDS uptake affects tobacco use and associated toxicity among AA smokers, particularly those who smoke menthol. Recently, FDA began regulating closed-system devices like JUUL, which have captured over 70% of the ENDS market and contributed to dramatic increases in youth ENDS use. As of early 2020, flavored ENDS cartridges (small, enclosed unit used as part of an ENDS) other than menthol/tobacco are banned in the US. However, to achieve its public health mission, the FDA must balance restricting access to ENDS flavors that appeal to youth with the need for evidence on “whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products” (FDA, 2018). Understanding the potential of ENDS to reduce the public health burden of combusted tobacco use equitably requires a targeted study to predict how future ENDS flavor regulations will impact AA menthol smokers. The current study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210) by performing a 3-arm, parallel-group, 6-week clinical trial of ENDS provision with follow-up to 30 days. JUUL devices with compatible cartridges at 5% nicotine, which our team has extensively evaluated, will be provided. Study arms will differ by potential FDA regulations on ENDS flavor availability: 1) the current market where only menthol and tobacco flavored ENDS cartridges are available; 2) a market where only tobacco flavor is available, and 3) a market with only unflavored cartridges. Study visits will occur weekly beginning 1 week prior to randomization with daily tobacco use monitoring throughout and biomarker/self-report data collection at each weekly visit. AA menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated ENDS. Results of this work will help FDA make predictions about the impact on AA menthol smokers of moving from the current regulatory market for cartridge-based ENDS where menthol and tobacco are available, to one where only tobacco or no flavors are available. Answers to these questions will address FDA's priorities in behavior, toxicity, and addiction, and will provide new data regarding the consequences of potential FDA regulatory actions on menthol flavor ENDS to help maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.