METHODS: 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 identifying as Black vs. non-Black and will stratify randomization by race. To promote standardization and adherence, cigarette and e-cigarette products will be provided for 8 weeks based on the assigned condition: (A) no menthol restriction (menthol cigarette and menthol flavored e-cigarette), (B) menthol prohibited in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), (C) menthol prohibited in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up visit will occur at week 12 to assess tobacco use status. The study aims are to (1) examine the impact of prohibiting menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) investigate whether outcomes differ by race to understand the impact of menthol 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 during the 8-week study period and will examine differences by regulatory scenario. 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 policy scenarios by race.
CONCLUSIONS: Results will contribute critical information regarding menthol in cigarettes and e-cigarettes to inform regulatory policies that maximize reductions in cigarette smoking and reduce tobacco-related health disparities.
BACKGROUND: NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.
方法:我们将招募150名目前吸烟薄荷醇香烟的成年人,并将他们随机分配到3种条件中的1种,以模拟不同的监管方案。我们将招募相同数量的参与者,识别为Blackvs.非黑人,并将按种族分层随机化。促进规范和坚持,香烟和电子烟产品将根据指定的条件提供8周:(A)无薄荷醇限制(薄荷醇香烟和薄荷醇味电子烟),(B)薄荷醇只在香烟中禁止使用(非薄荷醇香烟和薄荷醇味电子香烟),(C)薄荷醇在香烟和电子香烟(非薄荷醇香烟和烟草味电子香烟)中被禁止。在第12周进行随访以评估烟草使用状况。该研究的目的是(1)研究在香烟和电子香烟中禁止薄荷醇风味对吸烟行为的影响,以及(2)调查结果是否因种族而异,以了解薄荷醇政策对布莱克的影响(与非黑人)个体在该人群中薄荷醇香烟的使用率很高。主要结果将评估8周研究期间每天吸烟数量的变化,并通过监管方案检查差异。次要结果将比较无烟天数的百分比,尼古丁依赖的变化,和动机,信心,以及根据监管方案戒烟的意图。我们将检查结果的变化是否因Black与非黑人参与者按种族比较各种薄荷醇政策方案的影响程度。
结论:结果将提供有关香烟和电子香烟中薄荷醇的关键信息,以告知监管政策,最大限度地减少吸烟并减少与烟草相关的健康差异。
背景:NCT05259566。耶鲁IRB协议#2000032211,最后批准12/8/2023。