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

电子烟的随机试验：自然吸收、模式和使用的影响

• 批准号: 8683480
• 负责人: Matthew J Carpenter
• 金额: $ 20.52万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8683480
• 关键词: Abstinence; Address; Adoption; Affect; Attention; Attitude; Behavior; Behavioral; Biological; Carbon Monoxide; Categories; Cigarette; Cigarette Smoker; Clinical Trials; Control Groups; Cotinine; Data; Electronics; Frequencies; Future; Generations; Goals; Growth; Individual; Industry; Intake; Italy; Literature; Low Prevalence; Manufacturer Name; Marketing; Methods; Nature; New Zealand; Nicotine; Outcome; Pattern; Perception; Pilot Projects; Prevalence; Procedures; Process; Publishing; Randomized; Randomized Clinical Trials; Recurrence; Regulation; Sampling; Science; Smoker; Smoking; Smoking Behavior; Surveys; Time; Tobacco; Toxicant exposure; Visit; Withdrawal; authority; base; comparison group; control trial; craving; design; experience; falls; follow-up; indexing; innovation; multidisciplinary; novel; prospective; public health relevance; randomized trial; response; smoking cessation; smoking restriction; theories; time use; uptake

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.

描述（由申请人提供）：电子（e-）香烟是最新的，可以说是吸烟者可用的最受欢迎的非香烟产品，但令人惊讶的是，很少有研究提供关于消费者摄取模式的细节，也没有关于电子香烟使用对吸烟的影响的细节。大多数现有的研究主要使用基于自选电子烟使用者群体的横断面设计，仅提供粗略的使用指标（例如，从不与曾经与当前），很少关注摄取模式的细节。科学基础需要对新用户开始使用电子烟有更丰富的理解，包括1）吸收过程的多个指标，2）对电子烟使用的背景前因进行广泛评估，以及3）对这种生态环境如何触发使用的经验性理解。同样需要的是对电子烟使用如何影响并发和下游吸烟行为的深刻理解。文献中反复出现的一个主题是需要随机临床试验，但除了美国以外的两项研究，这两本书都还没有出版，不是吗 这样的审判是存在的。这种科学基础上的差距在美国尤其相关，其中所述 FDA已将电子烟归类为烟草产品，并明确表示要了解电子烟-吸烟者如何使用它们以及这种使用可能对吸烟行为产生什么影响。 作为试点（N=60），这项研究将为未来的研究提供重要信息，包括急需的大规模试验。我们的审判包括一个简短的（3 一周）的采样期，在此期间，没有使用过电子烟的吸烟者将有机会按照自己的意愿使用电子烟（与不使用电子烟相比）。这种抽样经验完全符合行业策略，提供免费样品，然后评估采用和替代，但我们与电子烟制造商的独立性是一个明显的研究优势。采样期间将通过生态瞬时评估（EMA）程序评估自然的吸收模式，以捕捉真实的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进行生物学验证将提供尼古丁暴露的前瞻性、客观指标，这再次加强了设计并推进了文献。我们的目标-以合理的精度收集摄入量的估计值，并在更大规模的试验之前评估效应大小-与我们的方法学范围一致。我们在所有提出的方法方面都有丰富的经验，包括小型和大型的临床试验，这些试验旨在检查吸烟者对非卷烟烟草产品的态度，摄入量和行为影响。我们的多学科团队与专家顾问一起组成了一个优秀的研究小组，非常适合这一创新提案，该提案是对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。