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

卷烟和电子烟薄荷醇监管对当前薄荷醇吸烟者烟草使用模式的影响

• 批准号: 10573766
• 负责人: Tracy Taylor Smith
• 金额: $ 72.04万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10573766
• 关键词: Adherence; Adult; Advocacy; Advocate; Behavior; Biological Markers; Calibration; Canada; Carbon Monoxide; Cessation of life; Characteristics; Cigarette; Clinical Trials; Cotinine; Coupled; Data; Dependence; Electronic cigarette; Electronics; Ensure; Europe; Face; Flavoring; Future; Health Benefit; Heterogeneity; Incentives; Individual; Intention; Legal; Litigation; Marketing; Medicine; Menthol; Methodology; Modeling; Nicotine; Participant; Patient Self-Report; Pattern; Policies; Population; Probability; Process; Public Health; Randomized, Controlled Trials; Regulation; Research Design; Research Priority; Smoke; Smoker; Smoking; Source; Study models; Techniques; Testing; Time; Tobacco; Tobacco Industry; Tobacco use; Uncontrolled Study; United States; United States Food and Drug Administration; Vulnerable Populations; attributable mortality; cigarette smoke; cigarette smoking; demographics; design; diaries; electronic cigarette use; electronic liquid; experimental study; nicotine exposure; non-cigarette tobacco product; population health; primary outcome; prospective; public policy on tobacco; secondary outcome; smoking cessation; success; tobacco flavor; tobacco products; treatment effect; urinary; vaping; years of life lost

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.

摘要 美国食品和药物管理局（FDA）正在努力最终确定对薄荷香烟的禁令。最后敲定禁令， 从烟草业的诉讼中走出来，实施禁令将是一个漫长的过程。一些 一些组织主张，包括薄荷醇在内的非烟草香料也应该被禁止使用。 烟草产品，如电子烟。尽管有大量关于薄荷醇的横断面和非对照研究， 我们几乎没有前瞻性的实验数据来调查薄荷醇禁令对烟草使用的影响， 在美国，薄荷醇吸烟者，甚至更少的证据表明薄荷醇禁令可能会相互作用 香烟薄荷禁令如果香烟和电子烟都禁止使用薄荷醇， 否则会尝试改用电子烟，可能会继续吸烟或戒烟 全部因此，香烟薄荷醇禁令对烟草使用变化的影响可能取决于 薄荷醇在电子烟中被禁止。拟定试验是一项2x2受试者间随机对照试验 调查香烟和电子烟的薄荷醇禁令对烟草使用模式的影响，包括 吸烟、电子烟使用、药用尼古丁使用和戒烟相关行为。当前薄荷醇 吸烟者（N=240）在被分配到薄荷醇或非薄荷醇组之前将完成1周的基线期 香烟和薄荷醇或烟草味的电子液体7周。为了示范禁令，吸烟者将被指示 仅使用指定产品，并使用自我报告和尿液生物标志物评估依从性 薄荷脑烟草使用模式的变化（每天吸烟、电子烟使用、戒除烟草的能力 吸烟）将通过电子日记（目标1）进行评估。次要结局包括吸烟和 电子烟的主观影响，以及香烟和电子烟依赖（目标2）。评估弃权的能力 参与者将在第7周完成为期1周的戒烟尝试练习，我们将评估 第一次吸烟失败。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 （呼出的一氧化碳，尿中的可替宁）。最后，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，以及对吸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统计学 或吸烟变量缓和治疗效果。然后，我们将校准治疗效果， 薄荷醇吸烟人群，并对吸烟和电子烟归因的死亡和寿命年的影响进行建模 损失（目标3）。强大的调查团队，加上我们成功地使用了拟议的方法， 成功实现我们目标的可能性。该项目将是迄今为止规模最大、最严格的临床试验， 直接测试卷烟和电子烟的薄荷醇法规对目前薄荷醇吸烟者的影响。