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.

项目摘要 电子尼古丁输送系统的使用（末端；电子烟）已达到流行性水平 美国的年轻人（美国）。结束热量并使含尼古丁的液体蒸发以产生 吸入气溶胶雾。虽然通常被认为比混合香烟的危害不太有害，但最终使用 使用户暴露于产生尼古丁，呼吸道和心血管毒物的依赖性 醛。风味是让年轻人使用末端的主要因素，因此将口味限制在精神病和 预填充墨盒末端的烟草“吊舱mods”是FDA采取的第一个重大行动，以减少 在年轻人中蔓延。但是，薄荷醇的风味可能会带来潜在的风险 在美国的年轻人中及其膨化和增强尼古丁的特性越来越受欢迎。然而， 精神病影响用户的经验和浮肿模式的能力的程度，以及这些影响如何影响 依赖性，对毒物的暴露和临床结果继续被了解。这样的证据将是 FDA设定进一步的监管标准以减少目的潜在伤害的能力至关重要。我们的团队 烟草监管科学专家将采用临床和分析实验室方法来解决这一差距 通过进行2x2（前X薄荷酚与烟草风味）的证据。我们将 招募当前/过去一个月的用户结束用户（n = 200，21 - 35年），他们将参加两个会议并使用 他们以精神病和烟草的口味结束。当我们应用标准和经过良好测试的实验室时 适用于调节相关研究的模型，我们为这些模型补充了这些模型 检测有毒物质终端相关排放的技术。拟议的研究将回答两个关键 法规问题与FDA一致，与FDA有关烟草产品成瘾和 毒性; 1）与烟草风味相比，心态通过增强浮肿，滥用责任，带来额外的风险 和最终用户的有毒物品暴露，并且； 2）这种效果在高依赖性中更为明显 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 使用或退出，以及诸如种族之类的小组比较，性将使FDA全面 评估监管法院的利弊，以期为社会的不同部门的评估结束。这样的 证据将有助于推进FDA监管政策，并有可能减少终点的伤害。