The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

项目总结/摘要 针对薄荷醇香料的烟草控制政策可能对公共卫生产生重大影响。当 添加到香烟中，薄荷醇增加了上瘾的可能性和依赖性，导致更多的吸入， 烟草有毒物质，并降低戒烟的可能性。这些影响在非洲尤其明显。 美国（AA）社区，其中有针对性的营销已导致AA的85%，而白色的20% 吸烟者使用薄荷香烟。FDA决定推进禁止薄荷醇的规则制定程序 香烟是缩小烟草相关疾病和死亡不成比例的差距的重要一步 AA吸烟者的经验该机构的监管行动没有包括薄荷味的电子烟， 香烟（EC）和辩论继续关于是否更全面的执法优先事项，包括 薄荷味的电子液体应该被颁布。虽然禁止薄荷味的EC可能会减少年轻人， 此外，由于是年轻人开始吸烟，因此也可能会阻碍成年薄荷醇吸烟者从烟草卷烟转向EC。 这可能会减缓减少危害的速度，并导致负面的公共卫生影响，集中在 少数种族/族裔社区已经不成比例地承受着烟草的负担。FDA已确认 EC调味剂对吸烟模式的影响作为研究的优先领域，迫切需要进行研究 审查管制行动对与烟草有关的健康差距可能产生的意外后果。 我们最近完成的随机临床试验（RCT）为成年吸烟者提供薄荷醇EC或烟草EC。 在薄荷醇吸烟者中，我们发现从烟草卷烟转换为EC的比率相当，烟草危害 减少、EC产品的使用以及使用烟草EC与薄荷EC的人之间的可接受性， 尽管这项研究受到样本量小的限制， 比较。这些数据与观察性研究一致，这些研究发现尼古丁-而不是香料- 推动成人EC使用者的使用，并提供强有力的初步证据支持限制薄荷味 欧共体对青年人有潜在的好处，但缺乏对成年吸烟者有害的证据。然而，前瞻性地 需要设计和充分动力的RCT来经验性地回答这个问题。本申请的目的 是为FDA提供急需的数据，以指导EC调味剂的监管行动。男性吸烟者（n=800）， 按种族和性别分层，有意转为EC的受试者将以1：1的比例随机分配至12周开放性研究中， 比较薄荷醇EC与烟草EC标签、非劣效性RCT。随访将持续至第26周。 中心假设是烟草EC在促进薄荷醇中EC的转换方面并不劣于薄荷醇EC 吸烟者。我们进一步假设，在减少烟草危害、使用EC产品或 随机接受烟草EC与薄荷醇EC的参与者之间的可接受性。该研究将提供关键的 向FDA提供数据，以告知薄荷醇EC的监管行动，该行动可能会减缓青年的开始， 对成年可燃香烟吸烟者转换的负面影响。

PROJECT SUMMARY/ABSTRACT Tobacco control policies targeting menthol flavoring could have a significant impact on public health. When added to cigarettes, menthol increases addictive potential and dependence, leads to greater inhalation of tobacco toxicants, and decreases the likelihood of cessation. These effects are particularly felt in the African American (AA) community where targeted marketing has resulted in ≈85% of AA versus ≈20% of White smokers using menthol cigarettes. The FDA’s decision to advance the rulemaking process to ban menthol cigarettes is an important step toward closing the gap in tobacco-related disease and death disproportionately experienced by AA smokers. The agency’s regulatory action stopped short of including menthol-flavored e- cigarettes (ECs) and debate continues about whether more comprehensive enforcement priorities inclusive of menthol flavored e-liquids should be enacted. While a ban on menthol flavored EC may reduce youth and young adult initiation, it may also discourage adult menthol smokers to switch from tobacco cigarettes to EC. This could slow harm reduction and result in a negative public health impact that would be concentrated in racial/ethnic minority communities already disproportionately burdened by tobacco. FDA has identified the impact of EC flavoring on smoking patterns as a research priority area, and there is an urgent need for studies that examine possible unintended consequences of regulatory actions on tobacco-related health disparities. Our recently completed randomized clinical trial (RCT) provided menthol EC or tobacco EC to adult smokers. Among menthol smokers, we found equivalent rates of switching from tobacco cigarettes to EC, tobacco harm reduction, EC product use, and acceptability between those who used tobacco EC versus menthol EC, although the study was limited by a small sample size and was not prospectively designed for these comparisons. These data are consistent with observational studies that have found that nicotine – not flavor – drive use in adult EC users and provide strong preliminary evidence to support restrictions on menthol flavored EC given potential benefit to youth and lack of evidence of harm to adult smokers. However, a prospectively designed and fully powered RCT is needed to empirically answer this question. The objective of this application is to provide much needed data to the FDA to guide regulatory action on EC flavoring. Menthol smokers (n=800), stratified by race and gender, who are interested in switching to EC, will be randomized 1:1 into a 12-week open label, non-inferiority RCT comparing menthol EC versus tobacco EC. Follow-up will continue through week 26. The central hypothesis is that tobacco EC are not inferior to menthol EC at facilitating a switch to EC in menthol cigarette smokers. We further hypothesize no difference in tobacco harm reduction, EC product use, or acceptability between participants randomized to tobacco EC versus menthol EC. The study will provide critical data to the FDA to inform regulatory action for menthol EC that could slow youth initiation with no resulting negative impact on switching in adult combustible cigarette smokers.