PDF(Pubmed)
Abstract：
BACKGROUND: 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.
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.
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.
摘要：
背景：薄荷醇香烟的使用仍然是一个很大的公共卫生问题，并且不成比例地影响美国黑人成年人。美国食品和药物管理局建议禁止在香烟中添加薄荷醇味，以保护公众健康。然而,电子香烟有薄荷醇味，是一种受欢迎的替代产品，如果香烟中禁止使用薄荷醇，成年人可能会转向。需要研究来了解薄荷醇的可用性(与烟草）调味的电子烟可能会影响吸烟薄荷醇香烟的成年人的香烟使用。
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。
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。
