The impact of menthol regulation for cigarettes and e-cigarettes on tobacco use patterns for current menthol smokers

摘要 美国食品和药物管理局(FDA)正在努力敲定薄荷醇香烟的禁令。最终敲定禁令， 应对烟草行业的诉讼，并实施禁令将是一个漫长的过程。一些人 一些组织主张，包括薄荷醇在内的非烟草调味品也应该禁止用于其他调味品 电子烟等烟草产品。尽管有大量关于薄荷醇的横断面和非对照研究， 我们很少有前瞻性的实验数据来调查薄荷醇禁令对 薄荷醇在美国的吸烟者，甚至更少的证据表明薄荷醇禁令对电子液体可能会产生怎样的影响 还有香烟薄荷醇禁令。如果薄荷醇在香烟和电子烟中都被禁止，那么吸薄荷醇的人 否则，我会尝试改用电子烟，可能会继续吸烟或戒烟 总而言之。因此，香烟薄荷醇禁令对烟草使用变化的影响可能取决于 电子烟中禁止使用薄荷醇。该试验为2x2受试者间随机对照试验。 调查薄荷醇对香烟和电子烟禁令对烟草使用模式的影响，包括 吸烟、电子烟的使用、药用尼古丁的使用以及戒烟相关行为。现行薄荷脑 吸烟者(N=240)在被分配到薄荷醇或非薄荷醇之前，将完成一周的基准期 香烟和薄荷脑或烟草味电子口服液，为期7周。为了模拟禁令，吸烟者将被指示 只使用他们指定的产品，依从性将使用自我报告和尿液生物标记物进行评估 为了薄荷醇。烟草使用模式的变化(每天吸烟、使用电子烟、戒烟能力 将通过电子每日日记(目标1)进行评估。次要结果包括吸烟和 电子烟的主观影响，以及香烟和电子烟的依赖(目标2)。评估弃权的能力 对于吸烟，参与者将在第7周完成为期1周的戒烟练习，我们将评估时间 为了第一次戒烟。吸烟和尼古丁暴露的生物标志物证实了自我报告的烟草使用 (过期一氧化碳、尿可替宁)。最后，关键是要了解薄荷醇监管将如何影响 美国薄荷醇吸烟者的全部人口，以及吸烟薄荷醇的弱势群体的影响 是集中的。因此，我们将使用先进的统计技术来评估是否有任何基线人口 或者吸烟变量会影响治疗效果。然后，我们将对美国的治疗效果进行校准 薄荷醇吸烟者的人数，并模拟吸烟和挥发对死亡和寿命的影响 迷失(目标3)。强大的调查团队，加上我们使用拟议方法的成功，增强了 实现我们目标的成功概率。该项目将是规模最大、最严格的临床试验 直接测试薄荷醇对香烟和电子烟的监管对目前薄荷醇吸烟者的影响。

Abstract The Food and Drug Administration (FDA) is working to finalize a ban on menthol cigarettes. Finalizing a ban, navigating litigation from the tobacco industry, and implementing the ban will be a lengthy process. Some organizations have advocated that non-tobacco flavorings, including menthol, should also be banned from other tobacco products like e-cigarettes. Despite the wealth of cross-sectional and uncontrolled studies of menthol, we have very little prospective, experimental data investigating the impact of a menthol ban on tobacco use for menthol smokers in the United States, and even less evidence on how a menthol ban for e-liquids might interact with a cigarette menthol ban. If menthol is banned from both cigarettes and e-cigarettes, menthol smokers who otherwise would have tried to switch to e-cigarettes may continue to smoke cigarettes or quit using tobacco altogether. Thus, the impact of a cigarette menthol ban on changes in tobacco use may depend on whether menthol is banned in e-cigarettes. The proposed trial is a 2x2 between-subjects randomized controlled trial investigating the impact of a menthol bans for cigarettes and e-cigarettes on tobacco use patterns including cigarette smoking, e-cigarette use, use of medicinal nicotine, and cessation-related behaviors. Current menthol smokers (N=240) will complete a 1-week baseline period before being assigned to either menthol or non-menthol cigarettes and either menthol or tobacco-flavored e-liquid for 7 weeks. To model a ban, smokers will be instructed to only use their assigned products, and adherence will be assessed using self-report and a urinary biomarker for menthol. Changes in tobacco use patterns (cigarettes smoked per day, e-cigarette use, ability to abstain from smoking) will be assessed through electronic daily diaries (Aim 1). Secondary outcomes include cigarette and e-cigarette subjective effects, and cigarette and e-cigarette dependence (Aim 2). To assess the ability to abstain from smoking, participants will complete a 1-week practice quit attempt in Week 7, and we will assess the time to first smoking lapse. Self-reported tobacco use is corroborated by biomarkers for smoke and nicotine exposure (expired carbon monoxide, urinary cotinine). Finally, it is critical to understand how menthol regulation will impact the entire population of US menthol smokers, as well as the effect on vulnerable groups where menthol smoking is concentrated. Thus, we will use advanced statistical techniques to assess whether any baseline demographic or smoking variables moderate the treatment effect. Then, we will calibrate the treatment effects to the US population of menthol smokers, and model the impact on smoking and vaping attributable deaths and life years lost (Aim 3). The strong investigative team, coupled with our success using the proposed methodology, enhances the probability of success in achieving our aims. This project will be the largest, most rigorous clinical trial to directly test the impact of menthol regulation for cigarettes and e-cigarettes on current menthol smokers.