Toxicant Exposure and Harm Perceptions in Cigarette Smokers Who Use or Do Not Use E-Cigarettes

项目总结/摘要 该提案解决了关于一个主要公共卫生问题的研究中的一个关键空白-使用电子 吸烟者的香烟（EC）。吸烟者认为减少吸烟的感知危害是吸烟的主要原因。 使用EC，烟草研究人员建议将EC作为一种潜在的减少危害的工具， 不能或不会戒烟的吸烟者。然而，目前的毒理学知识， EC主要限于实验室测试，在行为研究中几乎没有相应的证据。作为第一 人类行为EC研究中，通过烟草特有的亚硝胺，NNAL，一个高度 强有力的肺致癌物将被测量，该项目将解决该领域的关键障碍， 推进关于广泛使用EC减少危害的科学实践。此外，这将是第一个 一项研究旨在确定EC的摄取如何影响持续吸烟所涉及的认知-感知因素， 例如风险认知、吸烟的效用、戒烟的自我效能和烟草依赖。这项研究直接 与NIH的使命有关，以解决癌症风险因素，并支持长期目标，以减少 烟草使用的疾病负担。在目前的提案中，不打算戒烟的吸烟者 吸烟，表达对减少危害的兴趣，以及从未经常使用EC的人（一生中< 25次）将 以2：1的比例随机分配至EC组（n=120）或仅评估对照组（n=60）。那些 随机分配到EC的患者将接受12周供应的第二代EC入门套件， 从一个标准的列表。仅随机分配至评估组的受试者（n=60）将不提供EC。烟草 将在第0周（基线）、第4周、第8周和第12周评估两组中的消耗。毒性暴露的变化 (NNAL，一种原发性肺癌原和主要结局）和一氧化碳（CO）将被测量 从基线到第12周。目标1将描述随机分配到 EC组与随机分配至仅评估对照组的吸烟者相比;目标2将评估 使用电子烟对产品危害和效用的影响;目标3将阐明 烟草制品消费（可替宁验证）在吸烟者转向电子烟，并确定 这些模式的基线预测因子，包括人口统计学、吸烟史和心理社会学。 特色该项目将通过以下方式推动关于广泛使用EC以减少危害的科学实践： 这是第一个已知的研究，其中通过NNAL的有毒暴露和认知感知变量的变化 转换为EC的吸烟者将被描述并与继续使用EC的吸烟者进行比较。 只有香烟。研究结果将对公共卫生产生重大影响，特别是对吸烟者， 在戒烟方面遇到困难，对他们来说，使用EC作为减少危害的策略， 考虑了这项研究将加强PI大学的研究环境，该大学被列为 西班牙裔服务机构和亚裔美国人-土著美国人-太平洋岛民服务机构。

Project Summary/Abstract This proposal addresses a critical gap in the research regarding a major public health issue – use of electronic cigarettes (ECs) by smokers. Smokers cite reducing perceived harm from smoking as a leading reason for using ECs, and ECs have been suggested by tobacco researchers as a potential harm reduction vehicle for smokers who cannot or will not achieve smoking cessation. However, current knowledge of the toxicology of ECs is primarily limited to lab tests, with very little corresponding evidence in behavioral studies. As the first human behavioral EC study in which toxicant exposure via the tobacco-specific nitrosamine, NNAL, a highly potent pulmonary carcinogen will be measured, this project will address a critical barrier in the field and advance science on the widely used practice of EC use for harm reduction. Furthermore, this will be the first study to determine how uptake of ECs affects cognitive-perceptual factors involved in sustained tobacco use, such as risk perceptions, utility of smoking, self-efficacy to quit, and tobacco dependence. This study is directly relevant to the NIH’s mission to address cancer risk factors and supports the long-term objective to reduce the disease burden of tobacco use. In the current proposal, cigarette smokers who are not planning to quit smoking, express interest in harm reduction, and who have never been regular EC users (< 25 times in life) will be randomized in a 2:1 fashion to an EC group (n=120) or an assessment-only control group (n=60). Those randomized to EC will receive a 12 week supply of a second generation EC starter kit with their choice of liquid flavor from a standard list. Those randomized to assessment only (n=60) will not be provided with EC. Tobacco consumption in both groups will be assessed at weeks 0 (baseline), 4, 8, and 12. Changes in toxic exposure (NNAL, a primary lung carcinogen and the primary outcome) and carbon monoxide (CO) will be measured from baseline to week 12. Aim 1 will characterize the toxic exposure of cigarette smokers randomized to the EC group compared to cigarette smokers randomized to assessment-only controls; Aim 2 will assess the effects of uptake of e-cigarettes on perceptions of harm and utility of products; Aim 3 will illuminate patterns of tobacco product consumption (cotinine-verified) among smokers switching to electronic cigarettes and identify baseline predictors of those patterns, including demographic, smoking history, and psychosocial characteristics. This project will advance science on the widely used practice of EC use for harm reduction by being the first known study in which toxicant exposure via NNAL and change in cognitive-perceptual variables among smokers switching to EC will be characterized and compared to smokers who continue to use cigarettes alone. Study findings will have major public health implications, particularly for smokers who have experienced difficulty in quitting cigarettes and for whom EC use as a harm reduction strategy has been considered. The study will enhance the research environment at the PI’s university which is classified as both a Hispanic Serving Institution and an Asian American-Native American-Pacific Islander Serving Institution.