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

项目 4：青少年和年轻人使用电子烟和口服尼古丁袋产品的自然观察

• 批准号: 10666070
• 负责人: Amy K Ferketich
• 金额: $ 71.86万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666070
• 关键词: 3-Dimensional; Address; Adolescent and Young Adult; Adult; Age; Behavior; Categories; Characteristics; Cigarette; Classification; Complement; Data; Dependence; Dimensions; Disparity; Ecological momentary assessment; Electronic cigarette; Ensure; Environment; Equity; Evaluation; Evolution; Fostering; Goals; Harm Reduction; Industry; Isomerism; Laboratories; Laboratory Study; Lesbian Gay Bisexual Transgender; Manufacturer; Marketing; Mental disorders; Modified Risk Tobacco Product; Monitor; Nicotine; Nicotine Dependence; Observational Study; Ohio; Oral; Outcome; Participant; Pattern; Perception; Persons; Population; Proliferating; Public Health; Recording of previous events; Regulation; Research; Risk; Sales; Salts; Sampling; Science; Sensory; Smokeless Tobacco; Smoker; Surveys; Time; Tobacco; Tobacco Industry; Tobacco use; United States Food and Drug Administration; Universities; Withdrawal; Youth; addiction; base; craving; design; electronic cigarette use; experience; improved; novel; population health; prospective; queer; risk perception; rural dwellers; smokeless tobacco user; social; tobacco advertising; tobacco products; tobacco user; trend

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.

项目摘要 – 项目 4 过去十年，随着不可燃烟草的扩散，烟草产品格局发生了巨大变化。 电子烟（EC）和新型口服尼古丁袋（ONP）等烟草产品是最常用的烟草。 青少年和年轻人 (AYA) 和 ONP 的产品销量正在迅速攀升。 拥有操纵尼古丁三个维度（浓度、形态和异构体）以改善尼古丁的悠久历史 此外，该行业也有创造产品的历史。 毕业策略，其中一些产品（根据尼古丁维度定义）是新手的“入门产品” 用户和其他人对于长期用户来说是“稳健的”。此外，烟草行业将他们的产品与特定的产品配对。 旨在提高产品吸引力的营销策略 项目 4 (P4) 的目标是提供一个 全面了解尼古丁维度的行业策略如何影响产品 AYA 参与者对自然环境的看法、使用行为和依赖性。 我们将观察近期 EC 和 ONP 发起者（6 个月内）的全国样本（N = 2000；年龄 13-23）。 这些 AYA 的总体趋势，以及烟草业历史上优先考虑的人群的趋势 目标群体包括女同性恋、男同性恋、双性恋、跨性别者或酷儿 (LGBTQ+)、患有精神疾病的人 健康障碍和农村居民将被跟踪2年； 观察性研究将包括每 6 个月进行一次调查，并配合 3 次生态瞬时评估 (EMA) 爆发，以描述认知、使用和营销风险，目标 1 将决定 EC 和营销曝光。 随着时间的推移，ONP 在喜好、风险认知和社交方面会在尼古丁维度上被感知。 目标 2 将确定 EC 和 ONP 在尼古丁方面的使用升级模式。 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。 俄亥俄州立大学烟草监管科学中心整体综合主题“翻转剧本”： 利用行业的尼古丁手册，通过检查 EC 和烟碱的影响来最大限度地提高公众健康 ONP，根据其尼古丁特性和分类（入门型与强效型）以及对尼古丁的看法来定义 P4具有很强的生态效度，对年轻人进行自然观察。 行为来补充 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告知上市前烟草产品的应用和实质性 等效性审查、修改风险烟草产品决策和 P4 涉及 FDA。 成瘾、行为和营销的科学领域。