Non-Cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods

非卷烟烟草产品作为传统方法戒烟失败的吸烟者的减害工具

• 批准号: 10659453
• 负责人: Tracy Taylor Smith
• 金额: $ 72.61万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659453
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone; Abstinence; Address; Adult; Biochemical; Biological Markers; Carbon Monoxide; Centers for Disease Control and Prevention (U.S.); Chemicals; Cigarette; Cigarette Smoker; Clinical Trials; Communities; Data; Electronic cigarette; Exposure to; FDA approved; Harm Reduction; Health; Health Benefit; Instruction; Measures; Methods; Nicotine; Nitrosamines; Outcome; Participant; Patient Self-Report; Pharmaceutical Preparations; Pharmacotherapy; Play; Randomized; Research; Respiratory Signs and Symptoms; Risk; Role; Sales; Smoke; Smoker; Smoking; Smoking Behavior; Spirometry; Tobacco; Tobacco use; Toxicant exposure; United States Food and Drug Administration; behavioral outcome; cigarette smoking; combustible cigarette; design; evidence base; follow-up; heated tobacco products; improved; nicotine exposure; nicotine replacement; non-cigarette tobacco product; novel; primary outcome; randomized, clinical trials; recruit; respiratory health; secondary outcome; smoking abstinence; smoking cessation; success; tobacco abstinence; tobacco products; tool; urinary; varenicline

Abstract The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their health. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of non-cigarette tobacco products to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=225) will be randomly assigned to either 1) switch completely to a non-cigarette tobacco product (Switch Group, n=150), or 2) try to quit again using pharmacotherapy (Meds Group, n=75). Participants will choose among a limited menu of products or medications they would like to receive (maximizing external validity) and select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch Group will choose between two non-cigarette products that deliver sufficient nicotine and are appealing to adult smokers: e-cigarettes, the most commonly used non-cigarette tobacco product, or heated tobacco products, a novel tobacco product recently approved for sale by FDA as modified risk exposure compared to cigarettes. Both product classes, while not safe, emit fewer harmful chemicals compared to cigarettes. Participants in the Meds Group will choose between the two most effective pharmacotherapies available: varenicline or combination transdermal nicotine replacement therapy and short-acting nicotine lozenge. Participants in the Switch or Meds groups will receive a 9-week supply; broken down as: 1-week to use ad libitum while continuing to smoke, and 8-weeks to use as instructed following a Target Switch or Quit Date. The primary outcome is biochemically-confirmed abstinence from cigarette smoking at the 6-month follow-up, and secondary outcomes include smoking reduction > 50%, longest quit attempt duration, biomarkers of nicotine, smoke, and toxicant exposure, and changes in respiratory symptoms. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team. The trial is in line with priorities within NOT-OD-22-023 including “Harm reduction studies that involve switching from combustible cigarettes to ENDS [or heated tobacco products].”

抽象的 大多数吸烟者每年都试图戒烟，大多数戒烟尝试失败，即使是最有效的 使用了FDA批准的药物治疗。非耐燃性烟草产品发出的有害化学物质更少 比香烟，因此对于不能戒烟的吸烟者，完全切换到有害产品较小的产品 可能会改善他们的健康。对于未能使用传统方法戒烟的吸烟者，试图切换到 有害的产品可能更有可能帮助他们停止吸烟，而不是试图完全使用烟草 反复使用药物治疗。拟议的试验评估了非烟烟草产品的潜力 作为减少危害工具的工具，为已经尝试并失败的当前吸烟者退出了传统 方法。在过去一年中未能使用FDA批准的药物治疗戒烟的目前吸烟者（n = 225） 将随机分配到任何一个1）完全切换到非二烟烟草产品（开关组， n = 150），或2）尝试使用药物治疗再次退出（Meds组，n = 75）。参与者将在 他们希望获得的产品或药物菜单有限（最大化外部有效性），然后选择一个 目标开关 /退出日期将停止吸烟。开关组的参与者将在 两种提供足够尼古丁并吸引成年吸烟者的非烟产品：电子烟， 最常用的非烟烟草产品或加热的烟草产品，一种新型烟草产品 与香烟相比，最近被FDA批准为改良的风险暴露。两种产品课程，而 与香烟相比，不安全的有害化学物质更少。药物小组的参与者将选择 在两种最有效的药物治疗之间可用：Varenicline或组合透皮尼古丁 替代疗法和短效尼古丁lizenge。开关或药物组的参与者将获得 9周的供应；分解为：1周在继续抽烟的同时使用Ad Adbitum，而8周则用作 按照目标开关或退出日期的指示。主要结果是生化确认的禁欲 从6个月的随访中吸烟，次要结果包括降低吸烟> 50％， 最长的戒烟持续时间，尼古丁，烟雾和有毒物质的生物标志物以及呼吸的变化 症状。拟议的试验通过严格的设计解决了一个非常重要的研究问题，是 由一个强大的调查团队的支持。该试验符合NOT-OD-22-023中的优先级，包括“危害 还涉及从混合香烟转换为末端（或加热的烟草产品）的还原研究。”