The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

薄荷醇调味品对成年薄荷醇吸烟者转变的影响

基本信息

  • 批准号:
    10451121
  • 负责人:
  • 金额:
    $ 78.59万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-04-01 至 2027-03-31
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY/ABSTRACT Tobacco control policies targeting menthol flavoring could have a significant impact on public health. When added to cigarettes, menthol increases addictive potential and dependence, leads to greater inhalation of tobacco toxicants, and decreases the likelihood of cessation. These effects are particularly felt in the African American (AA) community where targeted marketing has resulted in ≈85% of AA versus ≈20% of White smokers using menthol cigarettes. The FDA’s decision to advance the rulemaking process to ban menthol cigarettes is an important step toward closing the gap in tobacco-related disease and death disproportionately experienced by AA smokers. The agency’s regulatory action stopped short of including menthol-flavored e- cigarettes (ECs) and debate continues about whether more comprehensive enforcement priorities inclusive of menthol flavored e-liquids should be enacted. While a ban on menthol flavored EC may reduce youth and young adult initiation, it may also discourage adult menthol smokers to switch from tobacco cigarettes to EC. This could slow harm reduction and result in a negative public health impact that would be concentrated in racial/ethnic minority communities already disproportionately burdened by tobacco. FDA has identified the impact of EC flavoring on smoking patterns as a research priority area, and there is an urgent need for studies that examine possible unintended consequences of regulatory actions on tobacco-related health disparities. Our recently completed randomized clinical trial (RCT) provided menthol EC or tobacco EC to adult smokers. Among menthol smokers, we found equivalent rates of switching from tobacco cigarettes to EC, tobacco harm reduction, EC product use, and acceptability between those who used tobacco EC versus menthol EC, although the study was limited by a small sample size and was not prospectively designed for these comparisons. These data are consistent with observational studies that have found that nicotine – not flavor – drive use in adult EC users and provide strong preliminary evidence to support restrictions on menthol flavored EC given potential benefit to youth and lack of evidence of harm to adult smokers. However, a prospectively designed and fully powered RCT is needed to empirically answer this question. The objective of this application is to provide much needed data to the FDA to guide regulatory action on EC flavoring. Menthol smokers (n=800), stratified by race and gender, who are interested in switching to EC, will be randomized 1:1 into a 12-week open label, non-inferiority RCT comparing menthol EC versus tobacco EC. Follow-up will continue through week 26. The central hypothesis is that tobacco EC are not inferior to menthol EC at facilitating a switch to EC in menthol cigarette smokers. We further hypothesize no difference in tobacco harm reduction, EC product use, or acceptability between participants randomized to tobacco EC versus menthol EC. The study will provide critical data to the FDA to inform regulatory action for menthol EC that could slow youth initiation with no resulting negative impact on switching in adult combustible cigarette smokers.
项目摘要/摘要 针对薄荷醇调味料的烟草控制政策可能会对公众健康产生重大影响。什么时候 添加到香烟中的薄荷醇会增加上瘾的可能性和依赖性,导致更多的人吸入 烟草毒物,并降低戒烟的可能性。这些影响在非洲尤为明显。 美国(AA)社区,有针对性的营销导致≈85%的AA与≈20%的怀特 使用薄荷醇香烟的吸烟者。FDA决定提前制定规则以禁止薄荷醇 香烟是缩小烟草相关疾病和死亡不成比例差距的重要一步 AA级吸烟者所经历的。该机构的监管行动没有包括薄荷醇口味的电子烟- 卷烟(ECs)和关于是否更全面的执法优先事项,包括 薄荷醇口味的电子液体应该颁布。而禁止薄荷醇口味的EC可能会减少年轻人和 对于年轻人来说,这也可能会阻止成年薄荷醇吸烟者从烟草转向EC。 这可能会减缓减少危害的速度,并导致负面的公共卫生影响,这些影响将集中在 已经不成比例地背负着烟草负担的种族/少数民族社区。FDA已经确定了 EC香料对吸烟模式的影响作为研究重点领域,迫切需要研究 审查了与烟草相关的健康差距监管行动可能产生的意外后果。 我们最近完成的随机临床试验(RCT)为成年吸烟者提供了薄荷脑EC或烟草EC。 在薄荷醇吸烟者中,我们发现从烟草香烟转向EC香烟的等价率,烟草危害 烟草EC和薄荷醇EC之间的减少、EC产品的使用和可接受性, 尽管这项研究受到样本量小的限制,而且不是针对这些人而设计的 比较。这些数据与观察性研究一致,这些研究发现尼古丁--而不是香料-- 在成年EC使用者中推广使用,并提供强有力的初步证据支持限制薄荷醇口味 欧共体给予年轻人潜在的好处,但缺乏对成年吸烟者有害的证据。然而,一个有前景的 需要设计和完全驱动的RCT来经验地回答这个问题。本应用程序的目标是 是向FDA提供急需的数据,以指导对EC调味品的监管行动。薄荷醇吸烟者(n=800); 按种族和性别分层,有兴趣改用EC的人将以1:1随机进入为期12周的开放 标签,非劣质对照试验,比较薄荷醇乳油和烟草乳油。后续工作将持续到第26周。 中心假设是,烟草EC在促进薄荷脑EC转变为EC方面并不逊色于薄荷醇EC 吸烟者。我们进一步假设在减少烟草危害、EC产品的使用或 随机分为烟草EC组和薄荷醇EC组的参与者之间的可接受性。这项研究将提供关键的 向FDA提供数据,以告知薄荷醇EC的监管行动可能会减缓青少年的成长,而不会产生任何结果 对成年可燃香烟吸烟者转换的负面影响。

项目成果

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NICOLE L NOLLEN的其他文献

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{{ truncateString('NICOLE L NOLLEN', 18)}}的其他基金

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
薄荷醇调味品对成年薄荷醇吸烟者转变的影响
  • 批准号:
    10594571
  • 财政年份:
    2022
  • 资助金额:
    $ 78.59万
  • 项目类别:
4th Generation e-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users
第四代电子烟对非裔美国吸烟者的影响:减少双重使用者的危害并戒掉可燃香烟
  • 批准号:
    10622313
  • 财政年份:
    2022
  • 资助金额:
    $ 78.59万
  • 项目类别:
Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in the African American community.
个体化药物治疗:一种促进非裔美国人社区戒烟的新型优化策略。
  • 批准号:
    10397553
  • 财政年份:
    2018
  • 资助金额:
    $ 78.59万
  • 项目类别:
Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in the African American community.
个体化药物治疗:一种促进非裔美国人社区戒烟的新型优化策略。
  • 批准号:
    10394471
  • 财政年份:
    2018
  • 资助金额:
    $ 78.59万
  • 项目类别:
Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in the African American community.
个体化药物治疗:一种促进非裔美国人社区戒烟的新型优化策略。
  • 批准号:
    9902392
  • 财政年份:
    2018
  • 资助金额:
    $ 78.59万
  • 项目类别:
Understanding Disparities in Quitting in African American and White Smokers
了解非裔美国人和白人吸烟者戒烟的差异
  • 批准号:
    8297355
  • 财政年份:
    2012
  • 资助金额:
    $ 78.59万
  • 项目类别:
Understanding Disparities in Quitting in African American and White Smokers
了解非裔美国人和白人吸烟者戒烟的差异
  • 批准号:
    8843404
  • 财政年份:
    2012
  • 资助金额:
    $ 78.59万
  • 项目类别:
Understanding Disparities in Quitting in African American and White Smokers
了解非裔美国人和白人吸烟者戒烟的差异
  • 批准号:
    8460068
  • 财政年份:
    2012
  • 资助金额:
    $ 78.59万
  • 项目类别:
Understanding Disparities in Quitting in African American and White Smokers
了解非裔美国人和白人吸烟者戒烟的差异
  • 批准号:
    8653949
  • 财政年份:
    2012
  • 资助金额:
    $ 78.59万
  • 项目类别:
Understanding Disparities in Quitting in African American and White Smokers
了解非裔美国人和白人吸烟者戒烟的差异
  • 批准号:
    9277607
  • 财政年份:
    2012
  • 资助金额:
    $ 78.59万
  • 项目类别:

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