A Naturalistic Nationwide Randomized Study of e-Cigarette Uptake and Consequences

关于电子烟吸食及其后果的自然主义全国随机研究

• 批准号: 9976470
• 负责人: Matthew J Carpenter
• 金额: $ 50.9万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9976470
• 关键词: Address; Adopted; Adoption; Attitude; Biological Markers; Cigarette; Cohort Studies; Control Groups; Cotinine; Coupled; Cross-Sectional Studies; Data; Drug Kinetics; Electronic cigarette; Exposure to; Glare; Goals; Grant; Individual; Knowledge; Literature; Methodology; Methods; Motivation; Natural History; Nicotine; Outcome; Outcome Measure; Pattern; Population; Positioning Attribute; Prevalence; Prevalence Study; Probability; Process; Prospective Studies; Publishing; Randomized; Randomized Clinical Trials; Recording of previous events; Recurrence; Research; Sample Size; Sampling; Sampling Studies; Science; Selection Bias; Smokeless Tobacco; Smoker; Smoking; Smoking Behavior; Surveys; Testing; Time; Tobacco; Tobacco Industry; Toxicant exposure; United States National Institutes of Health; Withdrawal; base; consumer behavior; craving; design; electronic cigarette use; electronic cigarette user; experience; follow-up; multidisciplinary; prospective; randomized trial; recruit; sound; success; tobacco control; tobacco exposure; uptake

Electronic (e-)cigarettes are by far the fastest growing segment of the non-combustible tobacco market available to smokers. Most studies of e-cigarettes are 1) lab-based studies of either pharmacokinetics or toxicant exposure 2) cross-sectional studies of prevalence and predictors of use or, more rarely, 3) uncontrolled cohort studies. The three randomized studies to date, all based outside the US, are cessation- focused and thus do not say anything about the natural process by which smokers adopt e-cigarettes, and how such adoption changes smoking behavior. Studies of naturalistic, self-determined used are important to understand real-world impact of e-cigarettes. Many of the existing studies are limited by methodological issues that constrain interpretation: selection bias resulting from comparisons of self-selected users vs. non-users, retrospective or cross-sectional designs that inhibit causal inferences, absence of biomarkers of exposure, and/or insufficient sample size. The absence of prospective, randomized but still ecological studies is a glaring omission in the literature. In fact, there has yet to be a study that a) randomizes smokers to e-cigarettes vs. not, b) is focused on naturalistic outcomes that occur in real time, c) is prospective, with sufficient follow-up duration, d) provides data on nicotine/tobacco exposure, e) is of sufficient sample size, and f) is US-based, an important consideration given upcoming regulatory changes. We know of no published study with even two of these criteria. We propose a nationwide randomized clinical trial in which smokers (N=660) are randomized to receive samples of e-cigarettes vs. not. Randomization will be 2:1 to increase precision of uptake outcomes (Aim 1). A subset of smokers (n=120) will be recruited locally, to assess the impact of e-cigarette use on biomarkers of exposure (Aim 2). Finally, though ours is not a cessation study, it would be a missed opportunity if we did not track cessation outcomes (Aim 3) or sufficiently power the trial to detect differences if they emerge. Thus, our study is designed and powered to address a comprehensive set of outcomes along three themes: 1) uptake and patterns of use, 2) biomarkers of exposure, and 3) changes in smoking. Importantly, these, dynamic changes will be captured in real time as they naturally unfold. We believe this will be the best test to date of the naturalistic population impact of e-cigarettes. Methods are strengthened by 1) large sample size (the largest e-cigarette RCT), 2) nationwide recruitment, with 3) locally recruited subset to assess biomarkers, and 4) multiple measures of outcome. The strong investigative team, coupled with our success in prior studies using similar methodology, collectively enhances the probability of success in achieving grant aims. We believe this study will offer an important contribution to the e-cigarette literature, and offer considerable implications for tobacco control, including vital information for regulatory agencies such as the FDA.

电子烟是迄今为止不可燃烟草市场中增长最快的部分 可供吸烟者使用。大多数电子烟研究是 1) 基于实验室的药代动力学或 毒物暴露 2) 流行率和使用预测因素的横断面研究，或者，更罕见的是，3) 非对照队列研究。迄今为止，三项随机研究均在美国境外开展，均已停止- 重点突出，因此没有提及吸烟者采用电子烟的自然过程以及如何 这种采用改变了吸烟行为。对自然主义、自我决定的使用的研究对于 了解电子烟对现实世界的影响。许多现有研究受到方法论问题的限制 限制解释：由于自我选择的用户与非用户的比较而产生的选择偏差， 抑制因果推论的回顾性或横断面设计，缺乏暴露的生物标志物， 和/或样本量不足。缺乏前瞻性、随机但仍然是生态学的研究是一个明显的问题 文献中的遗漏。事实上，目前还没有一项研究 a) 将吸烟者随机分为电子烟和香烟。 不是，b) 专注于实时发生的自然结果，c) 是前瞻性的，有足够的后续行动 持续时间，d) 提供有关尼古丁/烟草暴露的数据，e) 具有足够的样本量，f) 是基于美国的， 考虑到即将到来的监管变化，这是一个重要的考虑因素。据我们所知，还没有发表的研究涉及其中的两项 这些标准。 我们提议进行一项全国性随机临床试验，其中吸烟者 (N=660) 被随机分配接受 电子烟样品与非电子烟样品。随机化比例为 2:1，以提高摄取结果的精确度（目标 1）。 将在当地招募一部分吸烟者（n = 120），以评估电子烟使用对以下生物标志物的影响 曝光（目标 2）。最后，虽然我们的研究不是戒烟研究，但如果我们不这样做，那将是一个错失的机会 跟踪戒烟结果（目标 3）或充分加强试验以发现差异（如果出现）。因此，我们的 研究的设计和动力是为了解决围绕三个主题的一系列全面的结果：1) 吸收 和使用模式，2) 暴露的生物标志物，以及 3) 吸烟的变化。重要的是，这些动态的 当变化自然展开时，将被实时捕获。 我们相信，这将是迄今为止对电子烟对自然人口影响的最佳测试。方法有 1) 大样本量（最大的电子烟随机对照试验），2) 全国招募，3) 本地招募 招募子集来评估生物标志物，以及 4) 多种结果测量。强大的侦查团队， 加上我们之前使用类似方法进行的成功研究，共同提高了 成功实现赠款目标。我们相信这项研究将为电子烟的发展做出重要贡献 文献，并对烟草控制提供相当大的影响，包括监管的重要信息 FDA 等机构。