RAUORA: Cytisine Versus Varenicline for Smoking Cessation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 679
- 试验地点
- 1
- 主要终点
- Continuous abstinence from smoking
研究概览
简要总结
To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.
详细描述
Cytisine, a natural product, found in plants such as the Golden Rain and New Zealand Kowhai, partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several Central and Eastern European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. New Zealand research has shown cytisine to be more effective than nicotine replacement therapy at helping people quit smoking. Using a clinical trial design (N=2140) the investigators plan to investigate whether cytisine is at least as good as varenicline (the most effective, but most expensive, smoking cessation medication currently available in New Zealand) for helping Māori/family of Māori who smoke, to quit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •daily tobacco smokers
- •self-identify as Māori (indigenous New Zealander) or whānau (family) of Māori
- •want to stop smoking in the next two weeks
- •are at least 18 years of age
- •are able to provide verbal consent
- •reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at the time of enrolment
- •have daily access to a mobile phone with text capability and/or email and access to the internet via computer or smartphone
- •are eligible for subsidised varenicline under special authority conditions
排除标准
- •are pregnant or breastfeeding
- •are current users of other smoking cessation therapies (e.g. nicotine replacement therapy [NRT], buproprion [Zyban], clonidine, nortriptyline, e-cigarettes)
- •are enrolled in another smoking cessation programme or another smoking cessation study
- •have a contraindication for cytisine or varenicline
- •have used varenicline or cytisine in the past 12 months
- •have another person in their household involved in the trial
- •have moderate or severe renal impairment,
- •are being treated for active or latent TB
- •have been treated for a heart attack, stroke, or severe angina within the last two weeks
- •have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic)
- •have a history of seizures
研究组 & 干预措施
Cytisine plus behavioural support
12-week course of cytisine capsules (1.5mg), with a decreasing dosing regimen (9mg/day for days 1-3, 7.5mg/day for days 4-12, 6mg/day for days 13-16, 4.5mg/day for days 17-20, 3.0mg/day from days 21-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
干预措施: Cytisine (Drug)
Cytisine plus behavioural support
12-week course of cytisine capsules (1.5mg), with a decreasing dosing regimen (9mg/day for days 1-3, 7.5mg/day for days 4-12, 6mg/day for days 13-16, 4.5mg/day for days 17-20, 3.0mg/day from days 21-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
干预措施: Behavioural support (Behavioral)
Varenicline plus behavioural support
12-week course of Varenicline tablets (0.5mg/1mg), with an increasing dosing regimen (0.5mg/day for days 1-3, 1.0mg/day for days 4-7, 2.0mg/day for day 8-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also receive withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
干预措施: Behavioural support (Behavioral)
Varenicline plus behavioural support
12-week course of Varenicline tablets (0.5mg/1mg), with an increasing dosing regimen (0.5mg/day for days 1-3, 1.0mg/day for days 4-7, 2.0mg/day for day 8-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also receive withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
干预措施: Varenicline (Drug)
结局指标
主要结局
Continuous abstinence from smoking
时间窗: Six months post-quit date
Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
次要结局
- Medication compliance(Three months post-quit date)
- Continuous abstinence from smoking(12 months post-quit date (in 2/3 of sample))
- 7-day point prevalence abstinence from smoking(12 month post-quit date (in 2/3 of sample))
- Time to relapse back to smoking(12 month post-quit date (in 2/3 of sample))
- Acceptability of allocated treatment(Three months post-quit date)
- Cigarette withdrawal(Six months post-quit date)
- Cigarettes per day(12 month post-quit date (in 2/3 of sample))
- Smoking satisfaction, if smoking(Six month post-quit date)
- Health-related quality of life(Six months post-quit date)
- Use of other methods of cessation(Six months post-quit date)
- Adverse events(12 month post-quit date (in 2/3 of sample))
研究者
Natalie Walker
Associate Professor
University of Auckland, New Zealand