Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-cigarettes Among Daily and Non-Daily Smokers on Abuse Liability

项目摘要/摘要 《家庭吸烟预防和烟草控制法》(FSPTCA)授权FDA 限制香烟中的尼古丁含量，这可能会降低香烟的强度，导致尼古丁含量减少 上瘾和接触与烟草燃烧有关的有害毒物。最近，FDA 宣布打算对电子烟(e-cig)进行监管。我们几乎没有关于这种情况的信息 烟草市场的变化，特别是电子烟，将影响尼古丁滥用的责任。目标是 这项研究的目的是在可燃香烟中的尼古丁水平具有 被降低以满足潜在的监管标准，但在这个标准中，电子烟中尼古丁的替代来源 也是可用的。目标1和目标2将描述VLNCC和ECIG双重使用对滥用责任的影响 (尼古丁补偿和产品使用、喜好和RRE)在日常(DS)和间歇(ITS)吸烟者中， 分别进行了分析。目标3将描述双重产品使用对滥用责任的影响，其衡量标准为 回溯性测量、智能手机每日日记和使用智能手机EMA捕获的实时测量。 参与者将是80名每日(DS)和80名间歇性(ITS)不寻求治疗的成年吸烟者 经常使用电子烟的人。参与者将在第一阶段(基线；第一周)抽他们常用的品牌(UB)，并将 在阶段2(2-4周)内只吸VLNCC。在阶段3(5-7周)和4(8-10周)期间， 吸烟者将被指示自由使用指定的VLNCC和电子烟的任何组合(VLNCC ECIG)。全 受试者将接受电子CIG剂量(ECIG-Hi(36毫克/毫升)和ECIG-LO(8毫克/毫升))和订单计数器 平衡阶段3和4。这项提案的意义在于，它将为FDA提供关键的 关于双重使用极低尼古丁含量香烟(VLNCC)和电子烟的影响的信息 不同水平的尼古丁对尼古丁滥用责任的影响，通过尼古丁补偿、产品使用和 喜欢，相对强化EFfiCacy(RRE)，以及对戒断、渴望、影响和 在实验室和他们的自然环境中，每天(DS)和间歇性(ITS)吸烟者的满意度。 这些产品的共存引发了人们的疑问：VLNCC的潜在公共健康益处 在减少尼古丁滥用方面的责任可以通过同时使用电子烟来抵消。这一点的积极影响 研究将提供关于减少尼古丁滥用的影响的科学信息 在双重产品使用环境中将可燃香烟提高到非强化水平，这可用于 告知旨在促进公众健康的烟草监管战略。本研究的创新之处在于 我们的重点是DS和ITS两用的尼古丁滥用责任，以及我们使用多模式方法 关于滥用责任结构的衡量，包括使用EMA，因为人们对 双重用途对自然环境中这些滥用责任结构的影响。的增值功能 这项研究是对现有涉及VLNC和电子烟的TCORS的补充和扩展。

PROJECT SUMMARY/ABSTRACT The Family Smoking Prevention and Tobacco Control Act (FSPTCA) provides the FDA with authority to limit the nicotine content of cigarettes, which could reduce cigarette reinforcement and lead to less nicotine addiction and exposure to harmful toxicants associated with tobacco combustion. Recently, the FDA announced its intention to regulate the e-cigarettes (e-cig). We have very little information on how such changes in the tobacco market place, specifically e-cigarettes, will affect nicotine abuse liability. The objective of this study is to model abuse liability in a market in which the level of nicotine in combustible cigarettes has been lowered to meet a potential regulatory standard, but one in which an alternate source of nicotine in e-cigs is also available. Aims 1 and 2 will characterize the effects of dual use of VLNCC and ECIG on abuse liability (nicotine compensation and product use, liking, and RRE) among daily (DS) and intermittent (ITS) smokers, respectively. Aim 3 will characterize the effects of dual product use on abuse liability, as measured by retrospective measures, smartphone daily diary, and real-time measures captured using smartphone EMA. Participants will be 80 daily (DS) and 80 intermittent (ITS) non-treatment-seeking adult smokers who are not regular e-cig users. Participants will smoke their usual brand (UB) during Phase 1 (Baseline; week 1) and will exclusively smoke the VLNCC during Phase 2 (weeks 2-4). During phases 3 (weeks 5-7) & 4 (weeks 8-10), smokers will be instructed to freely use any combination of assigned VLNCC and e-cigs (VLNCC+ECIG). All subjects will receive both e-cig doses (ECIG-Hi (36 mg/ml) and ECIG-Lo (8 mg/ml)) with order counter balanced across phases 3 and 4. The significance of this proposal is that it will provide the FDA with critical information about the effects of dual use of very low nicotine content cigarettes (VLNCC) and e-cigs with differing levels of nicotine on nicotine abuse liability, as measured by nicotine compensation, product use and liking, relative reinforcing efficacy (RRE), and multi-modal assessments of withdrawal, craving, affect and satisfaction, among both daily (DS) and intermittent (ITS) smokers in the lab and in their natural environment. The coexistence of these products raises questions about whether the potential public health benefit of VLNCC at reducing nicotine abuse liability might be offset by the concurrent use of e-cigs. The positive impact of this study will be to provide scientific information on the nicotine abuse liability impact of reducing nicotine in combustible cigarettes to a non-reinforcing level within a dual product use environment, which can be used to inform tobacco regulatory strategies designed to promote the public health. The innovativeness of this study is our focus on the nicotine abuse liability of dual use by both DS and ITS, and our use of a multimodal approach to the measurement of abuse liability constructs, including the use of EMA, given that little is known about the effects of dual use on these abuse liability constructs in the natural environment. The value-added feature of this study is that it complements and extends findings from existing TCORS involving VLNC and e-cigarettes.