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

摘要 大多数吸烟者每年都试图戒烟，大多数戒烟尝试失败，即使是最有效的戒烟方法。 使用FDA批准的药物治疗。不可燃烟草产品排放更少的有害化学物质 因此，对于无法戒烟的吸烟者来说，完全转向危害较小的产品 可能会改善他们的健康状况。对于那些用传统方法戒烟失败的吸烟者来说， 一种危害较小的产品可能比试图完全戒烟更有可能帮助他们戒烟 反复进行药物治疗。拟议的试验评估了非卷烟烟草产品的潜力 作为减少危害的工具，为那些已经尝试过传统戒烟方法但失败的吸烟者提供 方法.过去一年内使用FDA批准的药物治疗未能戒烟的当前吸烟者（N=225） 将被随机分配到1）完全转换到非卷烟烟草产品（转换组， n=150），或2）尝试使用药物治疗再次戒烟（药物组，n=75）。参赛者将从一个 有限的产品或药物菜单，他们想收到（最大限度地提高外部有效性），并选择一个 目标转换/戒烟日期，他们将停止吸烟。交换机组的参与者将在 两种非香烟产品提供足够的尼古丁，并吸引成年吸烟者：电子香烟， 最常用的非卷烟烟草产品或加热的烟草产品，一种新型烟草产品 最近被FDA批准销售，与香烟相比，其风险暴露有所改善。两种产品类别，而 不安全，与香烟相比，排放较少的有害化学物质。药物组的参与者将选择 两种最有效的药物疗法之间：伐尼克兰或组合透皮尼古丁 替代疗法和短效尼古丁含片。Switch或Meds组的参与者将获得 9-每周供应;细分为：1周在继续吸烟的同时随意使用，8周作为 根据目标切换或退出日期指示。主要结局是生化证实的禁欲 在6个月的随访中吸烟，次要结果包括吸烟减少> 50%， 最长的戒烟尝试持续时间，尼古丁，烟雾和有毒物质暴露的生物标志物，以及呼吸系统的变化。 症状拟议的试验使用严格的设计解决了一个非常重要的研究问题， 由一个强大的调查团队提供支持。本试验符合NOT-OD-22-023中的优先级，包括“损害 减少研究涉及从可燃卷烟转向ENDS [或加热烟草产品]。

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].”