A Randomized Trial of E-cigarettes: Natural Uptake, Patterns, and Impact of Use

描述(申请人提供)：电子烟是最新的，也可以说是吸烟者可获得的最受欢迎的非香烟产品，但令人惊讶的是，很少有研究提供消费者接受模式的细节，也没有提供关于电子烟使用对吸烟的影响的细节。现有的大多数研究主要使用基于自选电子烟使用者群体的横断面设计，只提供粗略的使用指标(例如，从未与曾经与当前)，很少注意吸食模式的细节。科学基础需要对新用户中电子烟的启动有更丰富的了解，包括1)吸收过程的多个指标，2)对电子烟使用的背景前因的广泛评估，以及3)对这种生态背景如何触发使用的经验性理解。同样需要的是对电子烟的使用如何影响同时和下游吸烟行为的深刻理解。文献中反复出现的主题是随机临床试验的必要性，但除了美国以外的两项研究，这两项研究都还没有发表，没有 这样的审判是存在的。科学基础上的这一差距在美国尤其相关，其中 FDA已将电子烟归类为烟草产品，并明确表示希望了解电子烟--吸烟者如何使用电子烟，以及这种使用可能对吸烟行为产生什么影响。我们提出了第一个在美国使用电子烟的前瞻性随机试验。作为试点(N=60)，这项研究将为未来研究的产生提供重要信息，包括迫切需要的大规模试验。我们的审判包括一个简短的(3) 每周)抽样期，在此期间，以前没有使用过电子烟的吸烟者将有机会按自己的意愿使用(或不使用)电子烟。这种抽样体验完全符合行业策略，提供免费样本，然后评估采用和替代，但我们独立于电子烟制造商是一个明显的学习优势。采样期将通过生态瞬时评估(EMA)程序评估自然主义的吸收模式，以捕捉现实世界中使用的背景和性质。然后，我们的试验过渡到另外三个月的前瞻性随访，在此期间，我们将评估电子烟使用对吸烟行为的下游影响。在整个采样和随访期间对尼古丁摄入量的生物验证将提供尼古丁暴露的预期、客观指标，这再次加强了设计并推进了文献。我们的目标--以合理的精确度收集摄取量的估计，并在更大规模的试验之前评估效果大小--与我们的方法范围一致。我们在所有建议的方法方面都有丰富的经验，包括检查吸烟者对非香烟烟草产品的态度、摄取和行为影响的小型和大型临床试验。我们的多学科团队与专家顾问一起，组成了一个非常适合这一创新建议的杰出研究小组，这是对FDA进一步了解电子烟使用的性质和影响的意图的直接回应。

DESCRIPTION (provided by applicant): Electronic (e-) cigarettes are the newest and arguably the most popular non-cigarette products available to smokers, yet surprisingly few studies provide details on patterns of consumer uptake, nor on the impact of e- cigarette use on smoking. The majority of existing studies, which primarily use cross-sectional designs based on self-selected groups of e-cigarette users, provide only cursory indicators of use (e.g., never vs. ever vs. current), with little attention to details of uptake patterns. The science base is in strog need of a richer understanding of e-cigarette initiation among novel users, inclusive of 1) multiple indicators of the uptake process, 2) broad assessment of contextual antecedents of e-cigarette use, and 3) empirically derived understanding of how such ecological contexts trigger use. Equally needed is a strong understanding of how e-cigarette use impacts concurrent and downstream smoking behavior. A recurrent theme in the literature is the need for randomized clinical trials, but aside from two studies outside the U.S., neither of which is yet published, no such trial exists. This gap in the scientific base is especially pertinent in the U.S., wherein the FDA has classified e-cigarettes as a tobacco product and has expressed explicit intent to understand e- cigarettes - how smokers use them and what impact such use may have on smoking behavior. We propose the first prospective, randomized trial of e-cigarette use in the U.S. As a pilot (N=60), this study will provide important information for generation of future research, including large-scale trials that are so critically needed. Our trial includes a brief (3 week) sampling period, in which smokers with no prior e-cigarette use will be given the opportunity to use e-cigarettes (vs. not) as they wish. This sampling experience is wholly consistent with industry tactics, providing free samples and then assessing adoption and substitution, yet our independence from e-cigarette manufacturers is a clear study strength. The sampling period will assess naturalistic patterns of uptake via ecological momentary assessment (EMA) procedures to capture the context and nature of use in the real world. Our trial then transitions to prospective follow-up for an additional three months, during which we wil assess downstream effects of e-cigarette use on smoking behavior. Biological verification of nicotine intake throughout both the sampling and follow-up periods will provide prospective, objective indicators of nicotine exposure, which again strengthens the design and advances the literature. Our aims - to gather estimates of uptake with reasonable precision and to assess effect sizes in advance of a larger trial - are consistent with our methodological scope. We have strong experience in all proposed methods, including both small and large clinical trials that examine attitudes toward, uptake of, and behavioral effects of non-cigarette tobacco products among smokers. Our multidisciplinary team, in conjunction with expert consultants, comprises an outstanding study group that is ideally suited to this innovative proposal, which is offered in direct response to the FDA's intent to further understand the nature and impact of e-cigarette use.