Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.
Yale Cancer Center, New Haven, CT, USA.
BMC Psychiatry. 2024 Mar 12;24(1):201. doi: 10.1186/s12888-024-05619-0.
Menthol cigarette use remains a large public health problem and disproportionately affects Black adults in the United States. The Food and Drug Administration has proposed prohibiting menthol flavor in cigarettes to protect public health. However, e-cigarettes are available in menthol flavor and are a popular alternative product adults might switch to if menthol is prohibited in cigarettes. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes could impact cigarette use among adults who smoke menthol cigarettes.
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.
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.
NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.
薄荷醇香烟的使用仍然是一个严重的公共卫生问题，尤其在美国，黑人群体受其影响的比例过高。美国食品和药物管理局已提议禁止薄荷醇香烟，以保护公众健康。然而，薄荷醇电子烟是可用的，并且是成年人如果香烟中禁止使用薄荷醇可能会转而使用的一种受欢迎的替代产品。需要研究薄荷醇（与烟草）口味的电子烟的供应情况如何影响吸食薄荷醇香烟的成年人的吸烟行为。
我们将招募 150 名目前吸食薄荷醇香烟的成年人，并将他们随机分配到 3 种不同的监管情景模型中的 1 种。我们将招募数量相等的黑人参与者和非黑人参与者，并按种族分层随机化。为了促进标准化和依从性，将根据指定条件为参与者提供 8 周的香烟和电子烟产品：（A）不限制薄荷醇（薄荷醇香烟和薄荷醇口味电子烟），（B）仅禁止香烟中的薄荷醇（非薄荷醇香烟和薄荷醇口味电子烟），（C）禁止香烟和电子烟中的薄荷醇（非薄荷醇香烟和烟草口味电子烟）。第 12 周将进行随访，以评估吸烟状况。该研究旨在：（1）研究禁止香烟和电子烟中的薄荷醇风味对吸烟行为的影响；（2）研究结果是否因种族而异，以了解薄荷醇政策对该人群中高薄荷醇香烟使用率的黑人（与非黑人）个体的影响。主要结果将评估在 8 周研究期间每天吸烟量的变化，并按监管情景进行比较。次要结果将按监管情景比较无烟天数百分比、尼古丁依赖程度变化、戒烟动机、信心和意愿。我们将研究主要结果是否因黑人参与者和非黑人参与者的不同而有所不同，以比较不同薄荷醇政策情景对不同种族的影响程度。
结果将提供有关香烟和电子烟中薄荷醇的关键信息，为制定最大程度减少吸烟和减少与烟草相关的健康差异的监管政策提供信息。
NCT05259566。耶鲁大学伦理委员会协议#2000032211，最后一次批准日期为 2023 年 12 月 8 日。
