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.

项目总结： 迫切需要对电子烟(EC)口味的吸烟成本效益进行批判性研究。 因为FDA在没有这一重要信息的情况下做出了全面和有影响力的监管决定。令人惊讶的是， 没有一项独立的、长期的、随机的临床试验对非烟草的影响进行了实验研究。 香料ECs与烟草香料ECs在产品摄取、持续使用和完全转换方面的差异。而国家电视台 科学院、工程院和医学院的结论是，ECS的危害可能远远低于 可燃香烟，自2020年以来已有100多万种EC产品被取缔，范围明显缩小 市场。根据美国FDA的说法，这些产品下架的一个关键原因是 年轻人使用电子烟的情况有所上升，通常是带有风味的ECs。事实上，FDA的决定引用了制造商未能 提供充分的证据，证明对成年吸烟者的好处超过了有记录的风险 这表明，年轻人蒸发的显著增加显著地使天平先验地朝这个方向倾斜 限制欧共体口味。目前受限制的合法电子商务市场可能会减少青少年电子烟，但可能 无意中降低了ECS成功与传统香烟竞争的能力，减少了成年人 吸烟者试用和使用电子烟进行转换。FDA要求更有力和明确的研究评估 如果成年吸烟者有任何EC口味的好处。为了提供所需的科学证据，我们建议 全国性随机临床试验，以确定EC风味对1)产品摄取量和吸引力的影响，2) 吸烟渴望、症状和依赖，以及3)吸烟行为，包括持续性和完全性 从香烟转向ECS。我们还将使用联合尼古丁替代疗法(NRT、贴片和 作为FDA批准的比较器，以确定EC与NRT在 烟草使用行为。吸烟者(N=1,500)将被随机分为a)首选口味EC(PEC)；b)烟草口味 EC(TEC)；或c)联合NRT。产品将免费提供14周(更换前2周试用 日期，转换日期后12周的使用时间)。PEC参与者将获得他们喜欢的口味(S)和 在14周内改变口味。吸烟的变化将通过远程生化确认 在转换日期后12周(产品供应结束)和26周时呼出一氧化碳读数。 这项重大而创新的研究将是第一次向FDA提供关键和决定性的信息，如 对成年吸烟者中EC口味对烟草使用的影响。随着专业知识在全国范围内开展，大型- 作为一项大规模的EC和NRT试验研究，我们的团队是唯一适合进行这项调查的团队。如果我们的研究 在改用加味EC方面没有显著改善，然后继续销售这些 产品可能是站不住脚的；然而，如果改进是显著的，这些发现将提供关键的 制衡当前FDA的法规，并有助于未来的决策。