The effect of menthol on ENDS users' dependence, respiratory, and toxicants emission outcomes

薄荷醇对 ENDS 用户的依赖性、呼吸系统和毒物排放结果的影响

• 批准号: 10444519
• 负责人: Wasim Maziak
• 金额: $ 51.05万
• 依托单位: FLORIDA INTERNATIONAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10444519
• 关键词: Address; Aerosols; Affect; Aldehydes; Back; Behavior; Biological Availability; Cardiovascular system; Cigar; Cigarette; Clinical; Coughing; Country; Crossover Design; Data; Dependence; Deposition; Diffuse; Electronic Nicotine Delivery Systems; Electronic cigarette; Epidemic; Exposure to; Frequencies; Future; Gender; Inhalation; Intention; Laboratories; Lead; Liquid substance; Marketing; Measures; Menthol; Methods; Modeling; Nausea; Nicotine; Nicotinic Receptors; Outcome; Palpitations; Participant; Pattern; Perception; Persons; Pilot Projects; Plasma; Play; Policies; Predictive Value; Property; Pulmonary Function Test/Forced Expiratory Volume 1; Race; Regulation; Research; Respiratory Signs and Symptoms; Respiratory physiology; Risk; Robot; Role; Science; Smoking; Societies; Symptoms; System; Technology; Testing; Tobacco; Tobacco use; Toxic effect; Toxicant exposure; United States; Withdrawal; Woman; Xerostomia; abuse liability; addiction; combustible cigarette; comparison group; craving; design; experience; irritation; minority children; nicotine exposure; pod mods; public health relevance; recruit; respiratory; response; satisfaction; sex; social media; tobacco flavor; tobacco products; tobacco regulatory science; toxicant; vapor

PROJECT SUMMARY The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS heat and vaporize a nicotine-containing liquid to produce an inhalable aerosol mist. While generally considered less harmful than combustible cigarettes, ENDS use exposes users to dependence-producing nicotine and respiratory and cardiovascular toxicants such as aldehydes. Flavor is a major factor in getting young people to use ENDS, thus limiting flavors to menthol and tobacco for prefilled cartridge ENDS “pod mods” was the first major action taken by the FDA to reduce the spread of ENDS among young people. Menthol flavor, however, can present a potential risk given its increasing popularity among young people in the US, and its puffing and nicotine-enhancing properties. Yet, the extent of menthol’s ability to affect users' experience and puffing patterns, and how these affect dependence, exposure to toxicants, and clinical outcomes continue to be understudied. Such evidence will be critical to the FDA's ability to set further regulatory standards to reduce ENDS potential harm. Our team of experts in tobacco regulatory science will apply clinical and analytical laboratory methods to address this gap in evidence by conducting a 2x2 (pre-post x menthol vs. tobacco flavor) crossover clinical lab study. We will recruit current/past month ENDS users (n=200, 21-35 yrs), who will come to the lab for two sessions and use their ENDS once with menthol and once with tobacco flavors. While we apply standard and well-tested lab models suitable for regulatory-related research, we have supplemented these with cutting-edge puffing robot technology to detect ENDS-associated emissions of toxicants. The proposed studies will answer two key regulatory questions consistent with FDA’s focus on the role of flavor in tobacco products’ addiction and toxicity; 1) compared to tobacco flavor, does menthol carry additional risk by enhancing puffing, abuse liability, and toxicant exposure in ENDS users, and; 2) is this effect more pronounced among high dependence compared to other users. Other outcomes such as harm perception, satisfaction, clinical responses, intention to use or quit, and group comparisons such as according to race, and sex will allow the FDA a comprehensive assessment of the pros and cons of regulating mentholated ENDS for different segments of the society. Such evidence will help advance FDA regulatory policies with the potential to reduce ENDS harm.

项目概要 电子尼古丁输送系统（ENDS；电子烟）的使用已达到流行程度 美国（US）的年轻人。 ENDS 加热并蒸发含尼古丁的液体以产生 可吸入的气溶胶雾。虽然人们普遍认为电子尼古丁传送系统的危害性比可燃香烟低，但电子烟的使用 让使用者接触产生依赖性的尼古丁以及呼吸道和心血管毒物，例如 醛类。口味是促使年轻人使用 ENDS 的一个主要因素，因此将口味限制为薄荷醇和 用于预装烟弹的烟草 ENDS“pod mods”是 FDA 为减少烟弹使用量而采取的第一项重大行动 ENDS 在年轻人中的传播。然而，考虑到薄荷醇的味道，它可能会带来潜在的风险。 其在美国年轻人中越来越受欢迎，并且具有增强尼古丁的特性。然而， 薄荷醇影响用户体验和吸烟模式的能力程度，以及这些影响如何 依赖性、接触毒物和临床结果仍在研究之中。此类证据将 对于 FDA 制定进一步监管标准以减少 ENDS 潜在危害的能力至关重要。我们的团队 烟草监管科学专家将应用临床和分析实验室方法来解决这一差距 通过进行 2x2（前后 x 薄荷醇与烟草口味）交叉临床实验室研究来证明这一点。我们将 招募当前/过去一个月的 ENDS 用户（n=200，21-35 岁），他们将来实验室参加两次会议并使用 它们的结尾一次是薄荷醇，一次是烟草口味。当我们应用标准且经过充分测试的实验室时 适合监管相关研究的模型，我们用尖端的膨化机器人对这些模型进行了补充 检测与 ENDS 相关的有毒物质排放的技术。拟议的研究将回答两个关键问题 监管问题与 FDA 关注香料在烟草产品成瘾中的作用一致， 毒性; 1) 与烟草香精相比，薄荷醇是否会通过增强膨化、滥用倾向而带来额外的风险， ENDS 用户的毒物暴露，以及； 2）这种效应在高度依赖者中是否更明显 与其他用户相比。其他结果，例如伤害感知、满意度、临床反应、意图 使用或戒烟，以及根据种族和性别等进行分组比较，将使 FDA 能够全面了解 评估对社会不同阶层监管薄荷电子尼古丁传送系统的利弊。这样的 证据将有助于推进 FDA 监管政策，并有可能减少 ENDS 危害。