Impact of e-cigarette nicotine concentration on compensation, cigarette use, and biomarkers of exposure and harm in African American and White smokers

项目概要/摘要 电子烟（EC）的使用预计将在两年内超过吸烟。尼古丁盐基 EC由于其高浓度的尼古丁而引起了人们的关注，这可能导致其快速的 越来越受欢迎。美国食品和药物管理局（FDA）对EC具有监管权， 表示有兴趣探索产品标准，以限制EC电子液体中尼古丁的允许水平。而 拟议的产品标准有其优点，新兴的研究表明，它可能会导致一种产品， 成瘾，但更有害，特别是对非洲裔美国人（AA）吸烟者。AA吸烟者承担不成比例的 吸烟相关疾病的负担，代表了一个研究不足的人群， 与大多数人不同的产品。AA吸烟者采取更大的抽吸和吸入 比白人更爱抽烟虽然AA每天吸烟比白人少，但AA提取物 每支香烟的尼古丁含量增加30%，每支香烟的非尼古丁有毒物质含量更高。随着越来越多的AA吸烟者 至于转用长者中心，他们会如何使用这些产品，则不得而知。没有研究调查过 当使用EC时，AA和白色之间的补偿性抽吸作为尼古丁浓度的函数而不同 吸烟者或电子液体的尼古丁浓度如何影响他们的补偿，替代， 和EC相关的有毒物质暴露。拟议的研究将提供这一科学证据，为监管提供信息。 以及最大化公共健康益处并限制对不同用户的潜在危害。成年吸烟者（24 AA，24 W） 将完成两个研究阶段。在第一阶段，参与者将完成两次标准化的10口vaping bouts 然后是60分钟的自由吸烟时间，使用两种电子液体，仅在尼古丁浓度上有所不同 （5%对1.8%）。第1阶段将提供关于尼古丁补偿率的客观数据 浓度.在第二阶段，相同的参与者将被随机分配到5%或1.8%的尼古丁电子液体， 指示他们完全转换为6周。随机试验将使我们了解 1.8%与5%尼古丁电子液体对替代率和不良健康结果的比较功效， 包括在实际使用条件下短期暴露于非尼古丁成分。如果减少 尼古丁EC通过补偿，降低替代率， 和/或更多地暴露于有毒物质，那么这将表明尼古丁产品标准对 电子烟油中尼古丁的允许含量将导致一种产品同样令人上瘾，但可能更多 有害这项创新研究将为建立有效的监管机制提供科学基础。 制定尼古丁产品标准的战略，以优化公共健康。该项目将作为一个令人难以置信的 宝贵的培训经验，并将建立K 01候选人，博士埃莉诺Leavens，作为一个独立的 烟草监管科学家，并以实质性和可衡量的方式启动莱文博士的职业生涯。

PROJECT SUMMARY/ABSTRACT Electronic cigarette (EC) use is projected to exceed cigarette smoking within two years. Nicotine salt-based ECs have raised concerns due to their high concentrations of nicotine, potentially contributing to their rapidly increasing popularity. The US Food and Drug Administration (FDA) has regulatory authority over ECs and has shown interest in exploring a product standard to limit the allowable level of nicotine in EC e-liquids. While the proposed product standard has merit, emerging research suggests that it could lead to a product that is just as addictive but more harmful, particularly to African American (AA) smokers. AA smokers bear a disproportionate burden of smoking-related diseases and represent an understudied population with a propensity to use products in a way that is different compared to the majority population. AA smokers take larger puffs and inhale more intensely on cigarettes than whites. While AA smoke fewer cigarettes per day than whites, AA extract 30% more nicotine per cigarette and higher levels of non-nicotine toxicants per cigarette. As more AA smokers switch to ECs, it is not known how they will use these products. No studies have investigated how rates of compensatory puffing when using ECs differ as a function of nicotine concentration among AA and white smokers or how the nicotine concentration of e-liquids could influence their rates of compensation, substitution, and EC-related toxicant exposure. The proposed study will provide this scientific evidence to inform regulation and to maximize public health benefit and limit potential harm to diverse users. Adults smokers (24 AA, 24 W) will complete two study phases. In Phase 1, participants will complete two standardized, 10-puff vaping bouts followed by a 60-minute ad libitum vaping session, using two e-liquids that differ only by nicotine concentration (5% vs. 1.8%). Phase 1 will provide objective data regarding rates of compensation as a function of nicotine concentration. In Phase 2, the same participants will be randomized to 5% or 1.8% nicotine e-liquid and instructed to switch to them completely for 6 weeks. The randomized trial will allow us to understand the comparative efficacy of 1.8% vs. 5% nicotine e-liquid on substitution rates and adverse health outcomes, including exposure to non-nicotine constituents, in the short-term under real-world use conditions. If reduced nicotine ECs were to result in greater e-liquid consumption via compensation, reduced substitution rates, and/or greater exposure to toxicants, then this would suggest that a nicotine product standard placing a limit on allowable levels of nicotine in e-liquid would lead to a product that is just as addictive but possibly more harmful. This innovative study will provide the scientific foundation needed to establish effective regulatory strategies for nicotine product standards that optimize public health. The project will serve as an incredibly valuable training experience and will establish the K01 candidate, Dr. Eleanor Leavens, as an independent tobacco regulatory scientist and launch Dr. Leavens’ career in substantial and measurable ways.