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

项目概要-项目4 在过去十年中，烟草产品的格局发生了巨大变化， 烟草产品，如电子烟（EC）和新的口服尼古丁袋（ONP）。EC是使用最多的烟草 产品在青少年和年轻人（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、形式和异构体）以提高尼古丁的含量方面， 产品的感官体验和尼古丁释放。此外，该行业有创造产品的历史， 分级策略，其中一些产品（沿着其尼古丁尺寸定义）是新手的“启动器 用户和其他人对于长期用户来说是“健壮的”。此外，烟草业将其产品与特定的 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 全面了解尼古丁各方面的行业策略如何影响产品 感知，使用行为，和AYA在自然环境中的依赖。参与者将是 最近（6个月内）开始EC和ONP的国家样本（N = 2000;年龄13-23）。我们将观察 这些AYA的总体趋势，以及在优先人群中， 目标包括那些谁是女同性恋，男同性恋，双性恋，变性人，或酷儿（LGBTQ+），那些有精神病 健康问题和农村居民。参与者将在2年内接受随访;这一前瞻性研究 观察性研究将包括每6个月一次的调查，并结合3次生态瞬时评估 (EMA)突发，以表征感知，使用和营销曝光。目标1将决定EC和 ONP随着时间的推移和尼古丁维度的喜好，风险认知和社交方面被认为是 可接受性目标2将确定在尼古丁维度中使用EC和ONP的递增模式。 目标3将确定哪些尼古丁维度最能预测尼古丁依赖。P4支持 俄亥俄州州立大学的烟草监管科学中心的整体综合主题“翻转脚本”： 使用行业的尼古丁剧本，通过检查EC的影响， ONP，根据其尼古丁特征和初效与强效分类定义，以及对 在真实的世界中的营销。P4具有很强的生态效度，提供了对青年的自然主义观察 行为以补充P1-3中使用的受控实验室和实验评估。 跨项目的整合将直接为烟草产品上市前的应用提供信息， 等效性审查、修改风险烟草产品决定和产品标准。P4解决FDA问题 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.