Evaluating the potential impact of a menthol ban in cigarettes and e-cigarettes among current menthol smokers

项目总结/摘要 美国食品和药物管理局有权监管烟草产品的生产、营销和分销。 尽管《烟草控制法》禁止销售具有特征香味的卷烟，但薄荷卷烟 目前不受这一禁令的限制，薄荷香烟的使用仍然是一个严重的公共卫生问题。使用 薄荷香烟与更大的尼古丁依赖和更低的戒烟率有关， 薄荷醇香烟的使用率在全国黑人中最高，有助于烟草相关的健康 差距。有证据表明，禁止香烟中的薄荷醇香料将有利于公众健康。然而，在这方面， 薄荷醇香料也可用于其他烟草产品，如电子烟，这是最常见的 在成人中使用非卷烟烟草产品。当考虑对烟草产品的口味限制时， 为了保护公众健康，FDA可能会决定禁止在香烟、电子烟或这两种产品中使用薄荷醇。研究 需要了解薄荷醇（与烟草）口味电子烟的可用性如何影响卷烟 在禁止薄荷香烟之后使用。目前的项目将使用一个已建立的范例来模拟 这些薄荷醇管制方案对真实的世界吸烟行为的影响。我们将招募150名成年人， 目前吸烟薄荷香烟，并将他们随机分为3个条件之一，模拟不同的监管 场景我们将招募相同数量的参与者，他们认为自己是黑人与非黑人，并将分层 按人种随机分组。参与者将获得香烟和电子烟产品，使用8周 基于其指定条件：1）无薄荷醇禁令（薄荷醇香烟和薄荷醇味电子烟），2） 仅在香烟中禁止薄荷醇（非薄荷醇香烟和薄荷醇调味电子香烟），3）在两者中禁止薄荷醇 香烟和电子香烟（非薄荷醇香烟和烟草味电子香烟）。一周后的随访调查 一旦不再提供研究产品，12将评估烟草使用结果。本研究的目的是：（1） 研究禁止香烟和电子烟中的薄荷醇香料对吸烟行为的影响，以及2） 调查结果是否因种族而异，以了解薄荷醇禁令政策对黑人（与非黑人相比）的影响。 黑人）在这一人群中使用薄荷醇香烟的比例很高。主要结局将评估 每天吸烟数量的变化，并将根据监管情况检查差异。我们 将使用混合模型分析来评估吸烟行为的变化，监管方案将是一个介于- 受试者因素，时间将是受试者内因素。次要结果将比较吸烟天数百分比- 自由，尼古丁依赖的变化，以及戒烟的动机，信心和意图， 监管场景。我们将研究黑人与非黑人的结果变化是否不同 与会者按种族比较各种薄荷醇禁令情景的影响程度。结果将 提供关键信息，为有关香烟和电子烟中薄荷醇的监管政策提供信息， 最大限度地减少可燃性卷烟的使用，促进健康公平。

PROJECT SUMMARY/ABSTRACT The US FDA has the authority to regulate the manufacture, marketing, and distribution of tobacco products. Although the Tobacco Control Act banned the sale of cigarettes with characterizing flavors, menthol cigarettes are currently exempt from this ban, and menthol cigarette use remains a serious public health problem. Use of menthol cigarettes is associated with greater nicotine dependence and lower rates of quitting smoking, and rates of menthol cigarette use are highest nationally among Black people, contributing to tobacco-related health disparities. Evidence suggests that banning menthol flavor in cigarettes would benefit public health. However, menthol flavor is also available in other tobacco products, such as e-cigarettes, which are the most commonly used non-cigarette tobacco product among adults. When considering flavor restrictions on tobacco products to protect public health, the FDA could decide to ban menthol in cigarettes, e-cigarettes, or both products. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes would impact cigarette use following a ban of menthol cigarettes. The current project will use an established paradigm to model the impact of these menthol regulatory scenarios on real world smoking behavior. We will recruit 150 adults who currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory scenarios. We will recruit equal numbers of participants who identify as Black vs. non-Black and will stratify randomization by race. Participants will be provided with cigarette and e-cigarette products to use for 8 weeks based on their assigned condition: 1) no menthol ban (menthol cigarette and menthol flavored e-cigarette), 2) menthol ban in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up survey at week 12 will assess tobacco use outcomes once the study products are no longer provided. The study aims are to 1) examine the impact of banning menthol flavor in cigarettes and e-cigarettes on smoking behavior and 2) investigate whether outcomes differ by race to understand the impact of menthol ban policies on Black (vs. non- Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate changes in the number of cigarettes smoked per day and will examine differences by regulatory scenario. We will use mixed model analyses to evaluate changes in smoking behavior, regulatory scenario will be a between- subject factor, and time will be a within-subject factor. Secondary outcomes will compare percent days smoke- free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black participants to compare the magnitude of the effect of the various menthol ban scenarios by race. Results will contribute critical information to inform regulatory policies regarding menthol in cigarettes and e-cigarettes in order to maximally reduce the use of combustible cigarettes and promote health equity.