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

项目总结 电子尼古丁输送系统(电子烟；电子烟)的使用已达到#年的流行水平。 美国的年轻人。Ends加热并汽化含有尼古丁的液体以产生 可吸入的气雾雾。虽然通常被认为比可燃香烟危害小，但最终使用 使使用者暴露于产生依赖的尼古丁以及呼吸和心血管毒物，如 醛。味道是促使年轻人使用Ends的一个主要因素，因此将口味限制在薄荷醇和 用于预填充盒端的烟草“豆荚MOD”是FDA采取的第一项重大行动，以减少 目的是在年轻人中传播。然而，薄荷醇的味道可能会带来潜在的风险，因为它 在美国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吹气模式的能力的程度，以及这些影响 依赖性、毒物暴露和临床结果仍未得到充分研究。这样的证据将是 对于FDA制定进一步的监管标准以减少末端潜在危害的能力至关重要。我们的团队 烟草监管科学的专家将应用临床和分析实验室方法来解决这一差距。 证据是通过进行2x2(前后x薄荷醇与烟草香精)交叉临床实验室研究。我们会 招募当前/过去一个月结束的用户(n=200，21-35岁)，他们将来实验室进行两次会议并使用 它们的结尾一次是薄荷醇，一次是烟草味。当我们应用标准和经过良好测试的实验室时 适合于监管相关研究的模型，我们已经用尖端的吹气机器人补充了这些模型 检测与末端相关的毒物排放的技术。拟议的研究将回答两个关键问题 监管问题与FDA对香精在烟草制品成瘾中的作用的关注一致 毒性；1)与烟草香精相比，薄荷醇是否有额外的风险，因为它增加了吸烟、滥用的可能性， 和最终使用者的毒物暴露，以及；2)这种影响在高度依赖的人中是否更明显 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 使用或戒烟，以及根据种族和性别等群体比较，将允许FDA全面 对社会不同阶层调节薄荷醇的利弊进行评估。是这样的 证据将有助于推进FDA的监管政策，有可能减少末端伤害。

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.