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

评估日常和非日常吸烟者同时使用尼古丁含量极低的香烟和电子烟的滥用责任

• 批准号: 9490473
• 负责人: PAUL MICHAEL CINCIRIPINI
• 金额: $ 16.38万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9490473
• 关键词: Address; Adult; Affect; Alkaloids; Anabasine; Attitude; Back; Cellular Phone; Cessation of life; Cigarette; Complement; Disease; Dose; Electronic cigarette; Environment; Exposure to; Family Smoking Prevention and Tobacco Control Act; Financial compensation; Health Benefit; Intention; Lead; Measurement; Measures; Minor; Modality; Modeling; Nicotine; Nicotine Dependence; Participant; Patients; Phase; Prevalence; Psychological reinforcement; Public Health; Questionnaires; Reporting; Research; Smoke; Smoker; Smoking; Smoking Behavior; Source; Time; Tobacco; Withdrawal; authority; base; craving; design; diaries; indexing; innovation; multimodality; negative affect; nicotine abuse; nornicotine; satisfaction; toxicant

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.

项目摘要/摘要 《家庭吸烟和烟草控制法》（FSPTCA）为FDA提供了授权 限制香烟的尼古丁含量，这可能会减少民用钢筋并导致较小的尼古丁 成瘾和暴露于与烟草组合有关的有害毒物。最近，FDA 宣布打算规范电子烟（E-cig）。我们几乎没有关于如何这样的信息 烟草市场（特别是电子烟）的变化将影响尼古丁滥用责任。目标 这项研究是在混合香烟中的尼古丁水平的市场中模范滥用责任 我们被降低以符合潜在的调节标准，但在该标准中，电子烟中的另一种尼古丁来源 也可用。目标1和2将表征VLNCC和ECIG对滥用责任的双重使用的影响 （尼古丁补偿和产品使用，喜欢和RRE）每日（DS）和间歇性吸烟者， AIM 3将表征双重产品使用对滥用责任的影响，如 回顾性测量，智能手机每日日记以及使用智能手机EMA捕获的实时测量。 参与者将每天80（DS）和80个间歇性的（ITS）非治疗的成年吸烟者 常规的电子烟用户。参与者将在第1阶段（基线；第1周）中抽烟，并将 在第2阶段（第2-4周）期间仅吸烟VLNCC。在第3阶段（第5-7周）和4（第8-10周）中， 吸烟者将被指示免费使用分配的VLNCC和E-烟（VLNCC+ECIG）的任何组合。全部 受试者将同时接受订单计数器 在第3和4阶段之间保持平衡。该提案的重要性是它将为FDA提供关键 有关尼古丁含量香烟（VLNCC）双重使用的影响 通过尼古丁补偿，产品使用和 喜欢，相对加强效率（RRE）以及戒断，渴望，影响和的多模式评估 在实验室和自然环境中的每日（DS）和间歇性吸烟者之间的满意度。 这些产品的共存引发了有关VLNCC潜在的公共卫生是否益处的疑问 减少尼古丁滥用责任可能会被同时使用电子烟所抵消。这对此的积极影响 研究将提供有关减少尼古丁的尼古丁责任影响的科学信息 在双重产品使用环境中，可燃的公民在非增强水平上达到非增强水平，可用于 告知旨在促进公共卫生的烟草监管策略。这项研究的创新性是 我们关注DS及其双重使用的尼古丁滥用责任，以及我们对多模式的使用 鉴于对滥用责任构建的衡量，包括使用EMA，鉴于对 双重使用对自然环境中这些滥用责任结构的影响。增值功能 这项研究是，它从涉及VLNC和电子烟的现有TCOR中完成并扩展了发现。