A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

烟味与非烟味电子烟对吸烟行为的综合评价

• 批准号: 10572739
• 负责人: Tracy Taylor Smith
• 金额: $ 79.74万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10572739
• 关键词: Abstinence; Adult; Advocate; Authorization documentation; Basic Science; Behavior; Biochemical; Carbon Monoxide; Cigarette; Cost Analysis; Costs and Benefits; Data; Decision Making; Dependence; Electronic cigarette; Engineering; Evaluation; Excision; Exhalation; FDA approved; Failure; Future; Investigation; Legal; Longitudinal cohort study; Manufacturer; Medicine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Patient Self-Report; Pattern; Policy Maker; Public Health; Randomized; Randomized, Controlled Trials; Reading; Regulation; Reporting; Research; Risk; Sales; Smoke; Smoker; Smoking; Smoking Behavior; Surveys; Symptoms; Testing; Therapy trial; Tobacco use; United States National Academy of Sciences; Withdrawal Symptom; Youth; authority; cigarette craving; cigarette smoke; cigarette smoking; combustible cigarette; cost; electronic cigarette use; electronic cigarette user; improved; innovation; nicotine craving; nicotine replacement; randomized trial; randomized, clinical trials; surveillance study; tobacco flavor; uptake; vaping; week trial

PROJECT SUMMARY: Studies critically examining the cost-benefit of electronic cigarette (EC) flavors on smoking are urgently needed as FDA is making sweeping and impactful regulatory decisions without this important information. Surprisingly, no independent, long-term, randomized clinical trial has experimentally examined the impact of non-tobacco flavored vs. tobacco flavored ECs on product uptake, sustained use, and complete switching. While the National Academies of Science, Engineering, and Medicine concluded that ECs are likely to be far less harmful than combustible cigarettes, more than 1 million EC products have been banned since 2020, significantly narrowing the marketplace. According to the US FDA, a key reason for the removal of these products was the significant rise in youth vaping, often with flavored ECs. Indeed, the FDA decisions cited a failure of manufacturers to provide sufficient evidence demonstrating that the benefits to adult smokers outweighed the “documented risks to youth,” suggesting that the significant rise in youth vaping significantly tipped the scales a priori in the direction of restricting EC flavors. The current restricted legal EC marketplace may reduce youth vaping but may inadvertently reduce the ability of ECs to compete successfully with conventional cigarettes, reducing adult smokers’ trial and use of e-cigarettes for switching. FDA requires more robust and definitive studies evaluating the benefit of EC flavors, if any, to adult smokers. To provide the needed scientific evidence, we propose a nationwide randomized clinical trial to determine the impact of EC flavors on 1) product uptake and appeal, 2) cigarette craving, symptoms, and dependence, and 3) smoking behavior, including sustained and complete switching from cigarettes to ECs. We will also utilize combination nicotine replacement therapy (NRT, patch and lozenge) as an FDA-approved comparator to determine the potential increased benefit (or not) of EC vs NRT on tobacco use behavior. Smokers (N=1,500) will be randomized to a) preferred flavor EC (PEC); b) tobacco flavor EC (TEC); or c) combination NRT. Products will be provided at no cost for 14 weeks (2-week trial before switch date, 12 weeks of use following switch date). PEC participants will be provided their preferred flavor(s) and able to change flavors throughout the 14 weeks. Changes in smoking will be biochemically confirmed via remote exhaled carbon monoxide reading at 12 weeks (end of product provision) and 26 weeks after the switch date. This significant and innovative study will be the first to provide the FDA with critical and definitive information as to the impact of EC flavors on tobacco use among adult smokers. With expertise conducting nationwide, large- scale EC and NRT trial research, our team is uniquely suited to conduct this investigation. If our study demonstrates no significant improvements in switching with flavored EC use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and aid future decision making.

项目摘要： 迫切需要研究电子文明（EC）口味的成本效益的研究 随着FDA在没有这些重要信息的情况下做出全面而有影响力的监管决策。出奇， 没有独立，长期的随机临床试验在实验上检查了非烟草的影响 在产品摄取，持续使用和完全切换方面，调味型与烟草调味EC。而国民 科学，工程和医学学院得出的结论是，EC可能远不及 自2020年以来禁止使用可燃香烟，超过100万个EC产品已大大缩小 市场。根据美国FDA的说法，去除这些产品的关键原因是重要的 在青年烟中崛起，经常会引发EC。确实，FDA的决定引用了制造商未能 提供足够的证据，表明对成年吸烟者的收益胜过“有记录的风险” 对年轻人来说，”表明，年轻人的大幅增长显着提高了尺度的先验 限制EC的口味。当前有限的法律EC市场可能会减少青年烟，但可能 无意中降低了EC成功与常规香烟竞争的能力，从而减少了成人 吸烟者的试验和使用电子烟进行切换。 FDA需要评估更强大和确定的研究 EC口味（如果有的话）对成年吸烟者的好处。为了提供所需的科学证据，我们建议 全国随机临床试验，以确定EC口味对1）产品摄取和外观的影响，2） 渴望香烟，症状和依赖以及3）吸烟行为，包括持续和完整 从香烟切换到ECS。我们还将利用组合尼古丁替代疗法（NRT，Patch和 作为FDA批准的比较器），以确定EC与NRT的潜在增加（或不增加） 烟草使用行为。吸烟者（n = 1,500）将被随机分为a）首选ec（PEC）； b）烟草风味 EC（TEC）;或C）组合NRT。产品将在14周内免费提供（切换前2周试用 日期，切换日期之后使用12周）。 PEC参与者将获得他们的首选风味和能力 在整个14周内改变口味。吸烟的变化将通过远程确认生化 呼出的一氧化碳在12周（产品结束）和切换日期后的26周后呼出。 这项重大而创新的研究将是第一个为FDA提供关键和确定信息的研究 EC口味对成年吸烟者中烟草使用的影响。在全国范围内进行专家，大型 扩展EC和NRT试用研究，我们的团队非常适合进行这项投资。如果我们的研究 通过激发EC的使用，没有显着改善，然后继续出售这些 产品可能是无可辩驳的；但是，如果改进很大，这些发现将提供关键 与当前的FDA法规相抵触，并帮助未来的决策。