Center of Excellence for the Acceleration of Harm Reduction, University of Catania, Catania, Italy.
Department of Educational Sciences, University of Catania, Catania, Italy.
JMIR Public Health Surveill. 2023 Apr 4;9:e42628. doi: 10.2196/42628.
BACKGROUND: People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. OBJECTIVE: We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. METHODS: We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide-confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. RESULTS: A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. CONCLUSIONS: Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. TRIAL REGISTRATION: ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748.
背景:对于那些吸烟且试图戒烟或希望继续吸烟的人来说,从传统香烟转向非燃烧尼古丁输送替代品,如加热烟草产品(HTP)和电子烟(EC),可能会受益。HTP 和 EC 越来越多地被用于戒烟,但关于它们的有效性的数据有限。
目的:我们进行了第一项随机对照试验,比较了 HTPS 和 ECs 在不打算戒烟的吸烟者中的戒烟率。
方法:我们进行了一项为期 12 周的随机非劣效性转换试验,比较了不打算戒烟的人群中 HTPS(IQOS 2.4 Plus)和可填充 ECs(JustFog Q16)之间的有效性、耐受性和产品满意度。戒烟干预措施包括动机咨询。研究的主要终点是从第 4 周到第 12 周(CAR 第 4-12 周)的一氧化碳确认连续戒烟率。次要终点包括从第 4 周到第 12 周(CRR 第 4-12 周)连续自我报告的香烟消费率减少≥50%,以及 7 天点吸烟禁欲率。
结果:共有 211 名参与者完成了研究。IQOS-HTP 和 JustFog-EC 的高戒烟率(CAR 第 4-12 周)分别为 39.1%(43/110)和 30.8%(33/107)。两组间 CAR 第 4-12 周的差异无统计学意义(P=.20)。IQOS-HTP 和 JustFog-EC 的 CRR 第 4-12 周值分别为 46.4%(51/110)和 39.3%(42/107),两组间差异无统计学意义(P=.24)。第 12 周时,IQOS-HTP 和 JustFog-EC 的 7 天点吸烟禁欲率分别为 54.5%(60/110)和 41.1%(44/107)。最常见的不良事件是咳嗽和体力下降。两种研究产品都引起了适度的愉快用户体验,且两组间差异无统计学意义。在切换到正在研究的无燃烧产品后,观察到运动耐量的临床相关改善。对传统香烟的风险感知始终高于正在研究的无燃烧研究产品。
结论:转向 HTP 可显著减少不打算戒烟的吸烟者的香烟消费,与可填充 EC 相当。在正在研究的 HTP 和 EC 之间,用户体验和风险感知相似。HTP 可能是减少风险的烟草替代品的有用补充,可能有助于戒烟。然而,需要进行更长时间的随访研究,以确认吸烟的显著和持久戒断,并确定我们的结果是否可以推广到不提供高水平支持的戒烟服务之外。
试验注册:ClinicalTrials.gov NCT03569748;https://clinicaltrials.gov/ct2/show/NCT03569748。
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