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

项目摘要 电子尼古丁输送系统（ENDS;电子烟）的使用已达到流行病的水平， 美国的年轻人（US）。加热并蒸发含尼古丁的液体， 可吸入气雾剂雾。虽然一般认为比可燃香烟危害小，但 使使用者暴露于产生依赖性的尼古丁以及呼吸道和心血管毒物， 醛类。口味是让年轻人使用ENDS的一个主要因素，因此将口味限制为薄荷醇， "豆荚式烟弹"是FDA采取的第一个主要行动，以减少 艾滋病在年轻人中蔓延。然而，薄荷味可能存在潜在的风险， 在美国的年轻人中越来越受欢迎，以及它的膨化和尼古丁增强特性。然而， 薄荷醇影响用户体验和抽吸模式的能力的程度，以及这些如何影响 依赖性、毒物暴露和临床结果仍然没有得到充分研究。这些证据将是 这对FDA制定进一步的监管标准以减少ENDS潜在危害的能力至关重要。我们的团队的 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2 × 2（前-后X薄荷醇与烟草香料）交叉临床实验室研究来证明。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 一次是薄荷味，一次是烟草味。虽然我们采用标准和经过良好测试的实验室 模型适合监管相关的研究，我们补充了这些与尖端的膨化机器人 检测ENDS相关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对烟草产品成瘾中香料作用的关注一致， 毒性; 1）与烟草香料相比，薄荷醇是否通过增强抽吸，滥用倾向， 和毒物暴露在ENDS用户，和; 2）这种影响是更明显的高度依赖 与其他用户相比。其他结果，如伤害感知、满意度、临床反应、意图 使用或退出，并根据种族和性别进行分组比较，将使FDA能够全面了解 评估对社会不同阶层管制含薄荷醇的ENDS的利弊。等 证据将有助于推进FDA监管政策，有可能减少ENDS的危害。

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.