Informing Tobacco Regulatory Policy Through Laboratory Assessment of Appeal and Demand for Flavored Tobacco Products Among Young Adults

项目摘要 这是响应RFA-OD-15-004的重新提交。它响应优先领域#4（电子烟），#6 （表征风味）和#9（消费者感知）。监测数据显示， 与其他任何年龄组相比，青少年和年轻成年人使用调味烟草制品（FTP）的比例约为18%。1 -4 据推测，这是为了掩盖烟草的刺激性，使新用户更容易开始吸烟。水果味的， 巧克力或薄荷口味的FTPs也有助于人们认为FTPs更安全，危害更小， 成瘾性比非FTPs，5，6所有这些都增强了他们的吸引力和吸引力，增加好奇心，并促进 烟草制品的实验。FTPs的实验与常规烟草的进展有关 青少年和年轻人（YA定义为18-24岁）的尼古丁使用和依赖。 被禁止的调味香烟，产品如薄荷香烟，以及调味雪茄，小雪茄/小雪茄，电子烟， 香烟和水烟不被禁止。需要及时进行研究，以确定FTP特性的影响， 如呼吁，好奇心，启动，并在弱势群体，包括青年人使用行为，使监管 可以根据经验采取行动，并适当确定目标，以最大限度地提高人口健康水平。电流限制 衡量烟草产品吸引力的一个重要因素是， 这些产品的已知危害，围绕其使用的社会规范和吸引力之间的潜在不和谐 产品营销和包装，包括调味品。6借鉴成瘾的双重过程模型， 研究采用多方法实验室和纵向设计，开发量化FTP吸引力的新方法， 滥用责任，解决这些限制，并将告知FDA对烟草产品的监管。我们会招募年轻人 成人（YA）当前烟草使用者（n = 60）和易感（从不）使用者（n = 60），并测量基线隐性吸引力 对于FTPs和非FTPs，以及上诉对6个月内烟草使用行为和态度变化的影响 使用每月网络评估。将通过两项实验室任务评估隐性吸引力： 关联任务（IAT），测量参与者准确配对FTPs与非FTPs图片的速度 与“有吸引力”或“没有吸引力”相关的单词，以及一项旨在评估 在不断上涨的价格条件下，对金融交易平台的需求与非金融交易平台的需求。如果隐式FTP上诉高于非FTP 吸引力，特别是在易感的从未使用者中，以及FTP吸引力是否对烟草使用结果产生负面影响 和态度，这表明FTPs是一种公共健康危害。结果可以告知潜在的FDA监管机构 关于FTP的决定，包括将加香卷烟禁令适用于其他烟草产品，限制销售 在成人专用场所提供免费烟草服务，并开展反烟草公共卫生运动，以减少免费烟草服务的吸引力。结果 将帮助PI在烟草监管研究中建立独立的职业生涯，并将为一个 烟草产品上诉的R 01将告知FDA对烟草产品的监管，以保护公众健康。

PROJECT SUMMARY This is a resubmission in response to RFA-OD-15-004. It responds to priority areas #4 (e-cigarettes), #6 (characterizing flavors), and #9 (consumer perceptions) in this RFA. Surveillance data document a high prevalence of flavored tobacco product (FTP) use among youth and young adults (~18%) relative to any other age group.1-4 Flavors have been hypothesized to mask the harshness of tobacco, making it easier for new users to initiate. The fruity, chocolatey, or minty flavors of FTPs also contribute to the perception that FTPs are safer and less harmful and addictive than non-FTPs,5,6 all of which enhance their appeal and attractiveness, increase curiosity, and facilitate experimentation with tobacco products. Experimentation with FTPs has been linked to progression to regular tobacco use and nicotine dependence in youth and young adults (YAs-defined as ages 18-24).7-11 Although the FDA has banned flavored cigarettes, products like menthol cigarettes, as well as flavored cigars, little cigars/cigarillos, e- cigarettes, and hookah are not banned. Timely research is needed to determine the impact of FTP characteristics, such as appeal, on curiosity, initiation, and use behavior in vulnerable groups, including YAs, so that regulatory actions can be empirically informed and appropriately targeted to maximize population health. The limitation of current measurements of tobacco product appeal is that appeal likely occurs implicitly - below conscious awareness - given potential dissonance between the known harms of these products, social norms surrounding their use, and the appeal of product marketing and packaging, including flavors.6 Drawing on the Dual Process Model of Addiction, this study uses a multi-method laboratory and longitudinal design to develop new methods for quantifying FTP appeal and abuse liability that address these limitations and will inform FDA regulation of tobacco products. We will recruit young adult (YA) current tobacco users (n = 60) and susceptible (never) users (n = 60) and measure baseline implicit appeal for FTPs and non-FTPs and the impact of appeal on changes in tobacco use behavior and attitudes over 6-months using monthly web-based assessments. Implicit appeal will be assessed via two laboratory tasks: an Implicit Association Task (IAT) that measures the speed with which participants accurately pair pictures of FTPs vs non-FTPs with words related to “attractive” or “unattractive”, and a behavioral economic purchase task designed to assess demand for FTPs vs non-FTPs under escalating price conditions. If implicit FTP appeal is higher than non-FTP appeal, especially among susceptible never users, and if FTP appeal negatively influences tobacco use outcomes and attitudes, this suggests that FTPs are a public health hazard. Results can inform potential FDA regulatory decisions about FTPs, including applying the flavored cigarette ban to other tobacco products, restricting the sale of FTPs to adult-only venues, and developing anti-tobacco public health campaigns to reduce appeal of FTPs. Findings will help the PI establish an independent career in tobacco regulatory research and will provide preliminary data for an R01 of tobacco product appeal that will inform FDA’s regulation of tobacco products to protect public health.