Impact of new standards for tobacco products among dual e-cigarette/combusted cigarette users

烟草制品新标准对电子烟/燃烧卷烟双重使用者的影响

• 批准号: 10160863
• 负责人: Francis Joseph McClernon
• 金额: $ 47.19万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10160863
• 关键词: Address; Adopted; Adult; Age; Area; Behavior; Characteristics; Cigarette; Data; Devices; Electronic cigarette; Family Smoking Prevention and Tobacco Control Act; Flavoring; Individual; Literature; Menthol; Minority; Modeling; Nicotine; Participant; Pattern; Policies; Population; Public Health; Regulation; Reporting; Research; Research Priority; Sampling; Science; Smoker; Tobacco; Tobacco use; Toxic effect; addiction; authority; cigarette user; electronic cigarette use; electronic cigarette user; electronic liquid; evidence base; experimental study; improved; low nicotine content cigarette; preference; primary outcome; public health relevance; secondary analysis; sex; tobacco advertising; tobacco products; tobacco regulatory science; vaper

The majority of experimental tobacco regulatory science (TRS) to date has focused specifically on the impacts of possible tobacco product standards (e.g. limit on e-cigarette flavoring) on the use of the single tobacco product targeted by the standard (e.g. e-cigarettes) among individuals who primarily or solely use the targeted product (e.g. vapers). Whereas this “single target” approach has yielded a large amount of actionable evidence, it has also resulted in a significant gap in the regulatory science evidence base for two interrelated reasons: First, the narrow focus on single tobacco product (STP) users has resulted in very little evidence on the impact of possible new product standards among multiple tobacco product (MTP) users who make up 30- 40% of the tobacco using population (10% of the U.S. adult population). Dual users of e-cigarettes (EC) and combusted cigarettes (CC) make up 40% of the MTP using population. Second, our preliminary evidence suggests that any two tobacco products vary in the degree to which they substitute for one another and that possible new product standards targeting one tobacco product may have an impact on the appeal and use of other tobacco products. In the proposed research, we will fill the gaps identified above by evaluating the effects of limiting EC e-liquid flavors to tobacco-only on the appeal of, and preference for, CC in a sample of adult dual users of EC and CC. In addition to evaluating the impact of limiting e-liquid flavor on the use of CC as they exist now (Aim 1), we will also examine the effects of limiting EC liquid on CC preference following standards that eliminate menthol in CC (Aim 2) and reduce CC nicotine content (Aim 3). We chose these possible policy actions as they have already been enacted at local levels, have been the subject of proposed rulemaking, or have been debated in the literature. In each experiment, adult dual EC/CC users will undergo preference sessions during which they will make choices between an EC and a CC. We hypothesize that restricting the flavor of EC to tobacco only, will increase preference for CC (Aim 1); that among menthol smokers, limiting EC to tobacco-only will increase choices for non-menthol CC relative to when EC are a preferred flavor, or when participants use their own EC device (Aim 2); and limiting EC to tobacco-only will increase choices for VLNC cigarettes relative to when EC are a preferred flavor, or the participant's own device (Aim 3). The proposed research will provide the FDA with actionable information on the impact of possible product standards for one tobacco product on the appeal and use other tobacco products. This research will be conducted among individuals who regularly use more than one tobacco product, and as such, are most vulnerable to changes in patterns of use of non-targeted products following changes in the characteristics of products targeted by new standards. Our aims are highly responsive to FDA research priorities as listed in RFA-OD-18-002 by evaluating how “changes in tobacco product characteristics (such as flavors…) impact on tobacco use behaviors including… dual/poly use, transition to non-flavored products, and …” (Addiction Priority Area).

迄今为止，大多数实验烟草监管科学（TRS）都专门关注影响 关于单一烟草使用的可能的烟草产品标准（例如电子烟香料的限制） 主要或仅使用该标准的目标产品（例如电子烟）的个人 产品（例如电子烟）。鉴于这种“单一目标”方法已经产生了大量可操作的 证据，这还导致两个相互关联的监管科学证据基础存在重大差距 原因：首先，对单一烟草产品（STP）使用者的狭隘关注导致很少有证据表明 可能的新产品标准对 30 名多种烟草产品 (MTP) 用户的影响 40% 的烟草使用者（占美国成年人口的 10%）。电子烟（EC）的双重使用者和 燃烧香烟 (CC) 占 MTP 使用人群的 40%。二、我们的初步证据 表明任何两种烟草产品相互替代的程度有所不同，并且 针对一种烟草产品的可能的新产品标准可能会对烟草产品的吸引力和使用产生影响 其他烟草制品。在拟议的研究中，我们将通过评估效果来填补上述空白 将 EC 电子烟液口味限制为纯烟草口味，以评估成人双重烟油样本中 CC 的吸引力和偏好 EC和CC的用户。除了评估限制电子烟油口味对 CC 使用的影响之外， 现在存在（目标 1），我们还将按照标准研究限制 EC 液体对 CC 偏好的影响 消除 CC 中的薄荷醇（目标 2）并降低 CC 尼古丁含量（目标 3）。我们选择了这些可能的政策 已在地方一级颁布的行动，已成为拟议规则制定的主题，或 文献中曾有过争论。在每个实验中，成人双 EC/CC 用户将受到优先选择 会议期间，他们将在 EC 和 CC 之间做出选择。我们假设限制 EC 仅对烟草有风味，会增加对 CC 的偏好（目标 1）；在薄荷醇吸烟者中，限制 EC 相对于 EC 为首选口味或当 参与者使用自己的 EC 设备（目标 2）；将 EC 限制为仅限烟草将增加 VLNC 的选择 相对于 EC 为首选口味或参与者自己的设备时的香烟（目标 3）。拟议的 研究将为 FDA 提供关于可能的产品标准对某一产品的影响的可操作信息 烟草制品对吸引力和使用其他烟草制品的影响。这项研究将在 经常使用一种以上烟草产品的个人，因此最容易受到环境变化的影响 随着新产品的目标产品特性发生变化，非目标产品的使用模式 标准。我们的目标高度响应 RFA-OD-18-002 中列出的 FDA 研究优先事项 评估“烟草产品特性（例如口味……）的变化如何影响烟草使用 行为包括……双重/多重使用、过渡到无味产品，以及……”（成瘾优先领域）。