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

项目总结。黑人/非裔美国人(AA)与烟草相关的癌症发病率最高， 任何种族/族裔群体的死亡率。超过70%的AA吸烟者将薄荷醇作为他们的常用品牌吸烟， 相比之下，白人吸烟者的比例为20%。薄荷醇是香烟中唯一允许的特征香味 目前的联邦法规，薄荷醇的使用与吸烟的进展有关，如 而且戒烟也更加困难。关于电子尼古丁输送系统影响的证据(结束， 例如，电子烟)表明，这些产品可能是一种危害较小的香烟替代品。很少的工作有 研究了END摄取如何影响AA吸烟者的烟草使用和相关毒性，特别是 那些抽薄荷醇的人。最近，FDA开始对JUUL等封闭系统设备进行监管，这些设备已经 占据了终端市场70%以上的份额，并为青年终端使用量的大幅增长做出了贡献。截至早些时候 2020年，除薄荷醇/烟草外的加味烟头(用作烟头的一部分的小型封闭式单元) 在美国是被禁止的。然而，为了实现其公共卫生使命，FDA必须在限制访问之间取得平衡 为了结束对年轻人有吸引力的口味，需要证据来证明某些口味是否以及如何起作用 成年吸烟者减少吸烟，转而使用可能危害较小的产品“(FDA，2018)。 了解END在公平减少焚烧烟草使用的公共卫生负担方面的潜力 需要一项有针对性的研究来预测未来的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薄荷醇口味的可用性是否会影响烟草使用的衡量标准， AA薄荷醇吸烟者(N=210)中香烟/烟蒂暴露和成瘾的生物标志物 3组，平行分组，为期6周的临床试验，终止供应，随访至30天。JUUL设备，带 将提供5%尼古丁的兼容墨盒，我们的团队已经进行了广泛的评估。学习武器 将因FDA关于Ends香精可用性的潜在法规而有所不同：1)当前市场上仅有薄荷醇 和烟草口味的末端墨盒可用；2)只有烟草口味的市场，以及3) 只有没有调味的墨盒的市场。研究访问将在随机化前一周开始每周进行 全程进行每日烟草使用监测，并在每周访问时收集生物标记物/自我报告数据。 AA薄荷醇吸烟者不成比例地受到烟草产品的伤害，并可能经历显著的 健康受益于更多可获得的、监管良好的目标。这项工作的结果将有助于FDA做出 预测从目前的监管市场转移到AA薄荷醇吸烟者的影响 在薄荷醇和烟草可用的情况下，以药筒为基础的结束，在只有烟草或没有香料的情况下 可用。对这些问题的回答将涉及FDA在行为、毒性和成瘾方面的优先事项，并将 提供有关FDA可能对薄荷醇香料末端采取监管行动的后果的新数据 帮助AA薄荷醇吸烟者最大限度地发挥促进健康的作用，并最大限度地减少意外后果。

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.