Project 4: A Naturalistic Observation of Electronic Cigarettes and Oral Nicotine Pouch Product Use Among Adolescents and Young Adults

项目摘要--项目4 在过去的十年里，随着非可燃物的扩散，烟草产品的格局发生了巨大的变化。 电子烟(ECs)和新型口服尼古丁胶囊(ONPs)等烟草产品。ECS是最常用的烟草 产品在青少年和青壮年(AYA)和ONP的销售正在迅速攀升。烟草业 在操纵尼古丁的三个维度(浓度、形态和异构体)以提高其质量方面有着悠久的历史 产品的感官体验和尼古丁输送。此外，该行业有创造一种产品的历史 毕业战略，即一些产品(根据尼古丁的维度定义)是新手的“初学者” 用户和其他人对于长期用户来说是“健壮的”。此外，烟草行业将他们的产品与特定的 旨在增加产品吸引力的营销策略。项目4(P4)的目标是提供一个 全面了解尼古丁领域的行业战略如何影响产品 阿雅在自然环境中的感知、使用行为和依赖。参与者将是 最近(6个月内)ECS和ONPs发起人的国家样本(N=2000；年龄13-23岁)。我们会观察到 在这些年鉴中的总体趋势，以及烟草业历史上一直以来的优先人群 目标包括女同性恋者、男同性恋者、双性恋者、变性人或同性恋者(LGBTQ)、精神障碍者 健康障碍，和农村居民。参与者将接受为期两年的跟踪调查；这一预期 观察性研究将包括每6个月一次的调查，并配以3次生态瞬时评估 (EMA)突发，以表征感知、使用和营销风险。目标1将决定ECS和 随着时间的推移，人们会在喜好、风险认知和社交方面跨尼古丁维度感知ONPs 可接受性。目标2将确定在尼古丁维度上使用ECs和ONPs的升级模式。 目标3将确定尼古丁的哪些维度最能预测尼古丁依赖。P4支持 俄亥俄州立大学烟草监管科学中心整体整合主题： 通过研究ECs和ECs的影响，利用行业尼古丁攻略最大化公共健康 ONPs，由它们的尼古丁特征和分类定义为初级品与强力品，以及对 在现实世界中进行营销。具有很强的生态效度，P4提供了对青年的自然主义观察 作为对P1-3中使用的受控实验室和实验评估的补充。 跨项目的整合将直接为烟草产品的上市前应用提供信息，并提供大量 等价性审查、修改的风险烟草产品决定和产品标准。P4针对FDA 成瘾、行为和营销的科学领域。

PROJECT SUMMARY – PROJECT 4 The tobacco product landscape changed drastically in the last decade with the proliferation of non-combustible tobacco products like e-cigarettes (ECs) and new oral nicotine pouches (ONPs). ECs are the most used tobacco product among adolescents and young adults (AYA) and ONP sales are climbing rapidly. The tobacco industry has a long history of manipulating three dimensions of nicotine (concentration, form, and isomer) to improve a product's sensory experience and nicotine delivery. Additionally, the industry has a history of creating a product graduation strategy whereby some products (defined along their nicotine dimensions) are “starter” for novice users and others are “robust” for longer-term users. Further, the tobacco industry pairs their products with specific marketing strategies designed to increase product appeal. The goal of Project 4 (P4) is to provide a comprehensive understanding of how industry strategies across the nicotine dimensions impact product perceptions, use behaviors, and dependence among AYA in the natural environment. Participants will be a national sample of recent initiators (within 6 months) of ECs and ONPs (N = 2000; ages 13-23). We will observe trends among these AYAs overall, and also among priority populations the tobacco industry has historically targeted including those who are lesbian, gay, bisexual, transgender, or queer (LGBTQ+), those with mental health disorders, and rural residents. Participants will be followed over a 2-year period; this prospective observational study will consist of surveys every 6 months, paired with 3 ecological momentary assessment (EMA) bursts, to characterize perceptions, use, and marketing exposures. Aim 1 will determine how ECs and ONPs are perceived over time and across nicotine dimensions in terms of liking, risk perceptions, and social acceptability. Aim 2 will identify patters of escalation in use of ECs and ONPs across the nicotine dimensions. Aim 3 will determine which nicotine dimensions are most predictive of nicotine dependence. P4 supports The Ohio State University's Tobacco Center for Regulatory Science overall integrative theme “Flipping the Script”: Using the Industry's Nicotine Playbook to Maximize Public Health by examining the impact of ECs and ONPs, defined by their nicotine characteristics and categorization as starter vs. robust, and perceptions of marketing in the real world. With strong ecological validity, P4 provides naturalistic observations of youth behavior to complement the controlled laboratory and experimental assessments that are used in P1-3. Integration across projects will directly inform premarket tobacco product applications and substantial equivalence reviews, modified risk tobacco product decisions, and product standards. P4 addresses FDA scientific domains of Addiction, Behaviors, and Marketing.