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： 迫切需要进行严格研究电子烟（EC）口味对吸烟的成本效益的研究 因为 FDA 在没有这些重要信息的情况下正在做出全面且有影响力的监管决策。出奇， 尚无独立、长期、随机的临床试验通过实验检验非烟草的影响 调味与烟草味 EC 在产品吸收、持续使用和完全转换方面的比较。虽然国家 科学、工程和医学院的结论是，EC 的危害可能远小于 EC 可燃卷烟，2020年以来已禁用超过100万支EC产品，大幅收窄 市场。根据美国 FDA 的说法，下架这些产品的一个关键原因是 青少年吸电子烟的人数有所增加，通常使用调味电子烟。事实上，FDA 的决定指出制造商未能 提供足够的证据证明成年吸烟者的好处超过了“记录在案的风险” 到年轻人”，这表明年轻人吸电子烟人数的显着增加，使天平先验地向以下方向倾斜： 限制 EC 口味。当前受限制的合法 EC 市场可能会减少青少年吸电子烟，但可能 无意中降低了电子烟与传统卷烟成功竞争的能力，从而减少了成人 吸烟者尝试和使用电子烟进行转换。 FDA 需要更强有力和明确的研究来评估 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，我们提出 全国随机临床试验，旨在确定 EC 口味对 1) 产品吸收和吸引力的影响，2) 吸烟渴望、症状和依赖性，以及 3) 吸烟行为，包括持续和完全吸烟 从香烟转向电子香烟。我们还将采用联合尼古丁替代疗法（NRT、贴剂和 锭剂）作为 FDA 批准的比较剂，以确定 EC 与 NRT 相比潜在增加的益处（或不增加） 烟草使用行为。吸烟者 (N=1,500) 将被随机分配到 a) 首选风味 EC (PEC)； b) 烟草香精 欧共体（TEC）；或 c) 联合 NRT。产品将免费提供 14 周（转换前试用 2 周） 日期，自切换日期起使用 12 周）。 PEC 参与者将获得他们喜欢的口味并能够 在 14 周内改变口味。吸烟的变化将通过远程生化确认 转换日期后 12 周（产品供应结束）和 26 周时的呼出一氧化碳读数。 这项重要且创新的研究将是第一个为 FDA 提供关键和明确信息的研究 EC 口味对成年吸烟者烟草使用的影响。凭借在全国范围内开展大型活动的专业知识 规模 EC 和 NRT 试验研究，我们的团队非常适合开展这项调查。如果我们的学习 表明使用调味 EC 的转换没有显着改善，然后继续销售这些 产品可能站不住脚；然而，如果改进显着，这些发现将提供关键的 平衡当前 FDA 法规并帮助未来的决策。