School of Public Health, The University of Queensland, Brisbane, Australia.
The Kirby Institute, University of New South Wales Sydney, Sydney, Australia.
Nicotine Tob Res. 2022 Jun 15;24(7):1079-1088. doi: 10.1093/ntr/ntab266.
Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: (1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and (2) offering e-cigarettes is more effective than NRT.
An open-label, parallel-group randomized trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomized to: (A) standard cessation advice and NRT: advice to use NRT short-term, (B) quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation, or (C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes.
At 7 months, 2.8% (N = 9) of group A (N = 324) were abstinent, compared with 1.8% (N = 11) in B (N = 620) and 1.3% (N = 8) in C (N = 619) (adjusted odds ratio [ORs]: B vs. A 0.66, 95% confidence interval [CI]: 0.27-1.63; C vs. A 0.46, 95% CI: 0.17-1.21; C vs. B 0.69, 95% CI 0.27-1.73). There were no suspected unexpected serious adverse reactions associated with trial products.
A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care.
The trial was registered with the Australian Therapeutic Goods Administration under their Clinical Trials Notification scheme and the Australian and New Zealand Clinical Trials Registry (ACTRN12612001210864).
This pragmatic trial allowed the comparison of existing and alternative policy options under semi-realistic conditions, such as product choice and financial cost. All trial arms had low rates of smoking cessation. The findings suggest that providing unflavored cigalike e-cigarettes without additional support may not increase quitting compared with advice to use standard NRT in a general population of Australians who smoke. More intensive support and education, and/or opportunity to try a range of e-cigarette products, may be required to motivate quit attempts using e-cigarettes.
减少烟草危害有可能改善个人和人口健康。然而，关于低强度干预措施的研究很少，例如鼓励长期使用尼古丁替代疗法或电子烟。我们旨在确定：（1）鼓励长期使用尼古丁产品作为烟草替代品对戒烟是否比标准治疗更有效，以及（2）提供电子烟是否比尼古丁替代疗法更有效。
2014 年至 2015 年，在澳大利亚进行了一项开放性、平行组随机试验，纳入了 1563 名成年每日吸烟者，随机分为：（A）标准戒烟建议和尼古丁替代疗法：建议短期使用尼古丁替代疗法，（B）戒烟或替代建议和尼古丁替代疗法：如果需要维持戒烟，则建议将尼古丁替代疗法作为长期替代吸烟的替代品，或（C）戒烟或替代建议和尼古丁替代疗法和/或电子烟。为参与者提供了最初的产品供应，然后他们可以在长达 7 个月的时间内购买。主要结局是 7 个月时自我报告的持续吸烟戒断。点流行率、双重使用和吸烟量减少是次要结局。
7 个月时，A 组（n=324）中有 2.8%（n=9）戒烟，B 组（n=620）中有 1.8%（n=11），C 组（n=619）中有 1.3%（n=8）（调整后的优势比[ORs]：B 与 A 0.66，95%置信区间[CI]：0.27-1.63；C 与 A 0.46，95% CI：0.17-1.21；C 与 B 0.69，95% CI 0.27-1.73）。试验产品未出现疑似意外严重不良反应。
与常规护理相比，免费试用尼古丁替代疗法和第一代电子烟并长期替代的方法对戒烟没有更好的效果。
该试验已在澳大利亚治疗商品管理局根据其临床试验通知计划和澳大利亚和新西兰临床试验注册中心（ACTRN12612001210864）进行了注册。
这项实用试验允许在半现实条件下比较现有的和替代的政策选择，例如产品选择和经济成本。所有试验组的戒烟率都较低。研究结果表明，在澳大利亚一般吸烟人群中，提供无口味的雪茄状电子烟，而不提供额外支持，与建议使用标准尼古丁替代疗法相比，可能不会增加戒烟尝试。可能需要更强化的支持和教育，和/或有机会尝试一系列电子烟产品，以促使尝试使用电子烟戒烟。
