A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,124
- 试验地点
- 1
- 主要终点
- Continuous abstinence (Russell Standard)
研究概览
简要总结
A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.
详细描述
A pragmatic, double-blind, three-arm randomised controlled trial undertaken in New Zealand to determine whether e-cigarettes combined with nicotine patches can assist smokers in remaining abstinent for at least six months. 1809 smokers who are motivated to quit will be recruited from the community using media advertising and randomly allocated to one of three groups, namely 1) 21mg nicotine patch daily, 2) 21mg nicotine patch daily plus a 'new generation' e-cigarette with no nicotine or 3) 21mg nicotine patch daily plus a 'new generation' e-cigarettes with nicotine. Participants will be instructed to start using the study products two weeks prior to their quit date, and continue for a further 12 weeks after their quit date. Participants will also receive a cessation behavioural support programme consisting of at least six follow-up telephone calls (10-15 minutes each) over the first six weeks. Outcome data will be collected on the participant's set quit date, then one, three, six and (for some but not all) 12 months post-quit date.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Smoke and want to quit in the next three months
- •Reside in New Zealand
- •At least 18 years of age
- •Able to provide verbal consent
- •Have access to telephone (mobile and/or landline)
- •Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
- •Only one person per household is eligible.
排除标准
- •Pregnant women
- •Women who are breastfeeding
- •Current users of NRT products
- •People currently enrolled in another smoking cessation programme or other cessation study
- •People who have used an e-cigarette for more than one week in the last year for smoking cessation
- •Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline).
- •People who have had a heart attack, stroke or severe angina within the previous two weeks.
- •People who self-report a history of severe allergies and/or poorly controlled asthma.
研究组 & 干预措施
Patch and nicotine-free e-cigarette
21mg nicotine patch (daily) and nicotine-free e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: Behavioural support (Behavioral)
Patch
21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit
干预措施: Nicotine patch (Drug)
Patch
21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit
干预措施: Behavioural support (Behavioral)
Patch and nicotine-free e-cigarette
21mg nicotine patch (daily) and nicotine-free e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: Nicotine patch (Drug)
Patch and nicotine-free e-cigarette
21mg nicotine patch (daily) and nicotine-free e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: e-cigarette (Device)
Patch and nicotine e-cigarette
21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: Nicotine patch (Drug)
Patch and nicotine e-cigarette
21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: e-cigarette (Device)
Patch and nicotine e-cigarette
21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: Nicotine (Drug)
Patch and nicotine e-cigarette
21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
干预措施: Behavioural support (Behavioral)
结局指标
主要结局
Continuous abstinence (Russell Standard)
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 (expired air carbon monoxide).
次要结局
- Smoking reduction(Participant's set quit date, then one, three, six and 12 months post quit date)
- Dual use(Participant's set quit date, then one, three, six and 12 months post quit date)
- Time to relapse(One, three, and six months post quit date)
- Continuous abstinence(One, three and 12 months post quit date)
- 7-day point prevalence abstinence(Participant's set quit date, then one, three, six and 12 months post quit date)
- Number of cigarettes smoked(Participant's set quit date, then one, three, six and 12 months post quit date)
- Serious adverse events(Participant's set quit date, then one, three, six and 12 months post quit date)
- Medication compliance(Participant's set quit date, then one and three months post quit date)
- Additional e-cigarette support(Participant's set quit date, then one, three, six and 12 months post quit date)
- Cost(Participant's set quit date, then one, three, six and 12 months post quit date)
- Perception of their allocated product(s)(Participant's set quit date, then one and three months post quit date)
- Self-efficacy(Participant's set quit date)
- Use of any other smoking cessation methods/products(Participant's set quit date, then one, three, six and 12 months post quit date)
- Withdrawal(Participant's set quit date, then at one month post quit date)
- Crossover(Participant's set quit date, then one, three, six and 12 months post quit date)
- Continuation of treatment use(Six and 12 months post quit date)
- Recommendations(Participant's set quit date, then one and three months post quit date)
研究者
Natalie Walker
Associate Professor of Population Health (Honorary)
University of Auckland, New Zealand