Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Drug Alcohol Depend. 2022 Mar 1;232:109312. doi: 10.1016/j.drugalcdep.2022.109312. Epub 2022 Feb 9.
Traditional randomized controlled trials have demonstrated the efficacy of pharmacotherapy for smoking cessation. However, accessibility to treatments remains a barrier, necessitating the remote delivery of evidence-based cessation interventions. The aim of this study was to evaluate the effectiveness of an online treatment that included first-line prescription medications using a pragmatic randomized controlled trial design.
This study was a two-group, parallel block randomized, open label, controlled trial, and conducted exclusively online. Participants were randomised (1:1) to either bupropion (150 mg) or varenicline (1 mg) for twelve weeks. Medication was couriered to participants. The primary outcome was 7-day point prevalence abstinence (PPA; defined as 0 cigarette puffs in the last 7 days) at 12 weeks. Secondary outcomes were 7-day PPA at 4-, 8-, 26-, and 52-weeks follow-up. Adverse events were evaluated at each follow-up session during treatment.
The varenicline group (n = 499) had significantly higher 7-day PPA (30.3%) compared to the bupropion group (n = 465; 19.6%) at end of treatment (OR=2.08, 95% CI: 1.49-2.90, p < 0.001). Seven-day PPA was also higher for the varenicline group at 4-weeks (OR=1.71, 95% CI: 1.23-2.40 p = 0.0001), and 8-weeks follow-up (OR=1.95, 95% CI: 1.43-2.67 p < 0.0001), but not at post-treatment follow-up. More adverse events were reported in the varenicline group, compared to bupropion.
This internet-based pharmacotherapy intervention was a feasible and effective method of treatment delivery for smoking cessation. This method can be used to increase the accessibility and availability of cessation interventions, decreasing the burden of smoking-related diseases.
This trial was registered with clinical trials.gov under NCT02146911. Registered 26 May 2014, https://clinicaltrials.gov/ct2/show/NCT02146911.
传统的随机对照试验已经证明了药物治疗戒烟的疗效。然而，治疗的可及性仍然是一个障碍，需要远程提供基于证据的戒烟干预措施。本研究旨在评估一种在线治疗方法的有效性，该方法包括使用实用随机对照试验设计的一线处方药物。
本研究为两组、平行分组、随机、开放标签、对照试验，完全在网上进行。参与者按 1:1 随机分配至安非他酮（150mg）或伐尼克兰（1mg）组，治疗 12 周。药物通过快递寄给参与者。主要结局是治疗 12 周时 7 天点现患率（PPA；定义为过去 7 天内没有吸烟）。次要结局是治疗后 4、8、26 和 52 周随访时的 7 天 PPA。在治疗期间的每次随访中评估不良事件。
与安非他酮组（n=465）相比，伐尼克兰组（n=499）在治疗结束时的 7 天 PPA（30.3%）显著更高（OR=2.08，95%CI：1.49-2.90，p<0.001）。伐尼克兰组在治疗后 4 周（OR=1.71，95%CI：1.23-2.40，p=0.0001）和 8 周随访（OR=1.95，95%CI：1.43-2.67，p<0.0001）时的 7 天 PPA 也更高，但在治疗后随访时则没有。与安非他酮相比，伐尼克兰组报告了更多的不良事件。
基于互联网的药物治疗干预是一种可行且有效的戒烟治疗方法。这种方法可以用来增加戒烟干预措施的可及性和可用性，减少与吸烟相关疾病的负担。
该试验在 clinicaltrials.gov 上注册，注册号为 NCT02146911。于 2014 年 5 月 26 日注册，网址为 https://clinicaltrials.gov/ct2/show/NCT02146911。
