National Drug and Alcohol Research Centre (NDARC), University of New South Wales (UNSW), Sydney, Australia.
Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
Addiction. 2019 May;114(5):923-933. doi: 10.1111/add.14541. Epub 2019 Feb 3.
Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline.
Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment.
Australian population-based study.
Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services.
Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions).
Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview.
If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.
戒烟药物有效，但由于成本和副作用，往往未被充分利用。烟碱是一种植物来源的戒烟药物，在中欧和东欧已使用超过 50 年。虽然已发现烟碱的耐受性良好，且比尼古丁替代疗法更有效，但尚未与维拉唑林进行直接比较。本研究评估了烟碱与维拉唑林相比的有效性、安全性和成本效益。
双臂、平行组、随机、非劣效性试验，采用分配隐匿和盲法结局评估。
澳大利亚基于人群的研究。
有兴趣戒烟的成年每日吸烟者（n=1266）将通过广告和戒烟热线电话戒烟支持服务招募。
符合条件的参与者将按照 1:1 的比例随机（随机分配）接受烟碱胶囊（25 天供应量）或维拉唑林片剂（12 周供应量），剂量根据制造商的推荐剂量方案规定。药物将邮寄到每位参与者指定的居住地址。所有参与者还将获得标准的戒烟热线行为支持（最多六次 10-12 分钟的会议）。
在基线、随机分组后 4 个月和 7 个月进行电话评估。还将在随机分组后 2 周和 4 周两次联系参与者，以确定不良事件、治疗依从性和吸烟状况。主要结局将是自我报告的 6 个月持续戒烟，7 个月随访时通过一氧化碳验证。我们还将评估烟碱与维拉唑林相比的相对安全性和成本效益。次要结局将包括在每个随访访谈中自我报告的持续和 7 天点吸烟率及吸烟量。
如果烟碱与维拉唑林一样有效，其较低的成本和天然植物成分可能使其成为一种可接受且负担得起的戒烟药物，可在全球范围内挽救数百万人的生命。
