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.

项目概要： 目前迫切需要对电子烟（EC）香料的成本效益进行严格审查的研究 因为FDA在没有这些重要信息的情况下做出了全面和有影响力的监管决定。令人惊奇的是， 没有独立的，长期的，随机的临床试验已经实验性地研究了非烟草的影响， 香味与烟草香味的EC对产品摄取、持续使用和完全转换的影响。而全国 科学、工程和医学院得出结论，EC的危害可能远小于 可燃卷烟，2020年起禁用100多万种EC产品，大幅收窄 市场。根据美国FDA的说法，这些产品被移除的一个关键原因是 在青年vaping上升，往往与调味EC。事实上，FDA的决定引用了制造商的失败， 提供足够的证据证明成年吸烟者的益处超过“记录的风险” 这表明，年轻人吸电子烟的显著增加， 限制EC口味。目前受限制的法律的EC市场可能会减少年轻人的电子烟，但可能会 无意中降低了EC与传统香烟成功竞争的能力， 吸烟者试用和使用电子烟转换。FDA要求进行更可靠和明确的研究， EC香料的益处，如果有的话，对成年吸烟者。为了提供所需的科学证据，我们提出了一个 全国范围内的随机临床试验，以确定EC风味对1）产品吸收和吸引力的影响，2） 烟瘾、症状和依赖性，以及3）吸烟行为，包括持续和完全吸烟 从香烟转向EC。我们还将使用尼古丁替代疗法（NRT，贴剂和 锭剂）作为FDA批准的对照药物，以确定EC与NRT相比， 烟草使用行为吸烟者（N= 1，500）将被随机分配至a）首选风味EC（PEC）; B）烟草风味 EC（TEC）;或c）组合NRT。产品将免费提供14周（转换前2周试用 日期，转换日期后使用12周）。PEC参与者将获得他们喜欢的口味， 在这14周里不断改变口味吸烟的变化将通过远程生物化学确认 转换日期后12周（产品供应结束）和26周时的呼出一氧化碳阅读。 这项重要的创新性研究将首次为FDA提供关键和明确的信息， EC香料对成年吸烟者烟草使用的影响。在全国范围内，大规模的- 大规模EC和NRT试验研究，我们的团队是唯一适合进行这项调查。如果我们的研究 表明没有显着改善切换与调味EC的使用，那么继续销售这些 产品可能是站不住脚的;但是，如果改进是显着的，这些发现将提供一个关键的 平衡当前FDA法规并帮助未来决策。