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

项目摘要/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 ECS因其高浓度的尼古丁而引起关注，这可能导致它们迅速 越来越受欢迎。美国食品和药物管理局(FDA)对ECS拥有监管权力，并已 有兴趣探索一种产品标准，以限制EC电子液体中尼古丁的允许水平。而当 拟议的产品标准有其优点，新出现的研究表明，它可能会导致产品与 令人上瘾，但危害更大，特别是对非裔美国人(AA)吸烟者。AA级吸烟者承受不成比例的 吸烟相关疾病的负担，并代表有吸食倾向的研究不足的人群 以一种与大多数人不同的方式生产产品。AA级吸烟者吸更大的烟并吸入 对香烟的依赖程度高于对白色香烟的依赖程度。虽然AA每天比白人吸烟更少，但AA提取物 每支香烟增加30%的尼古丁，每支香烟的非尼古丁有毒物质水平更高。随着更多的AA吸烟者 切换到ECS，目前还不知道他们将如何使用这些产品。目前还没有研究表明， 在AA和白色人群中，使用ECs时的代偿性吞吐作为尼古丁浓度的函数有所不同 或者电子烟的尼古丁浓度如何影响他们的代偿率、代替率、 和EC相关的毒物暴露。拟议的研究将提供这一科学证据，为监管提供信息。 并最大限度地提高公共健康效益，限制对不同用户的潜在伤害。成年吸烟者(24 AA，24 W) 将完成两个研究阶段。在第一阶段，参赛者将完成两个标准化的、10次喷雾的比赛 然后，使用两种尼古丁浓度不同的电子液体，进行60分钟的临时蒸发 (5%对1.8%)。第一阶段将提供与尼古丁有关的补偿率的客观数据 集中精神。在第二阶段，相同的参与者将被随机分配到5%或1.8%尼古丁电子口服液和 指示完全改用它们，为期6周。这项随机试验将使我们了解 1.8%尼古丁电子口服液与5%尼古丁电子口服液在替代率和不良健康后果方面的比较效果， 包括接触非尼古丁成分，在现实世界使用条件下的短期内。如果减少 尼古丁ECs将通过补偿、降低替代率、 和/或更大的毒物暴露，那么这将表明尼古丁产品标准对 电子烟中尼古丁的允许含量将导致产品同样上瘾，但可能更容易上瘾。 有害的。这项创新研究将为建立有效的监管提供所需的科学基础 尼古丁产品标准的战略，以优化公共健康。该项目将成为一个令人难以置信的 宝贵的培训经验，并将K01候选人埃莉诺·莱文斯博士确立为独立 烟草监管科学家，并以实质性和可衡量的方式启动Leaven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.