Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 807
- 试验地点
- 1
- 主要终点
- Proportion of participants with verified continuous smoking abstinence
研究概览
简要总结
This research focuses on maximizing the benefits of proven smoking cessation interventions to support people who smoke to quit, as part of the strategy to help New Zealand become smoke-free. A large, pragmatic community-based clinical trial is planned which draws on 15 years of smoking cessation research undertaken by the study team. This research has shown that both cytisine and nicotine e-cigarettes are more effective than nicotine replacement therapy at helping people to quit smoking, and are more acceptable to users. New Zealand research has also shown that text-messages offering advice and support around quitting smoking are highly effective and acceptable. The planned trial will test whether using cytisine and nicotine e-cigarettes together will help more New Zealanders to quit smoking long-term, compared to using cytisine alone or nicotine e-cigarettes alone. Participants in all three groups will also receive smoking cessation text-messaging behavioral support.
详细描述
Aim:
To evaluate the effectiveness, safety, and acceptability of combination treatment (cytisine plus nicotine e-cigarettes) compared to monotherapy (cytisine only or nicotine e-cigarettes only) on six-month smoking abstinence.
Trial design:
A single-blind, pragmatic three-arm, parallel group, pragmatic, community-based randomized trial.
Eligibility criteria:
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 smokers who live in New Zealand
- •Aged ≥18 years
- •Motivated to quit smoking within the next two weeks
- •Able to provide consent
- •Have daily access to a mobile telephone that can text
- •Have access to the internet via a computer or smart phone
- •Are willing to use cytisine or an e-cigarette or both products to help quit smoking
排除标准
- •Have another person in their household currently enrolled in the study
- •Are pregnant/breastfeeding, or are women trying to become pregnant in the next three months
- •Are currently using smoking cessation medication (including using e-cigarettes daily for the last month)
- •Are enrolled in another cessation programme/trial
- •Have a known hypersensitivity to cytisine or nicotine e-cigarettes
- •Self-report moderate/severe renal impairment
- •Are undergoing treatment for active/latent tuberculosis
- •Have experienced a myocardial infarction, stroke, or severe angina within the previous two weeks
- •Have uncontrolled high blood pressure (>150 mmHg systolic, >100 mmHg diastolic)
- •Have a history of seizures / epilepsy
- •Have a strong preference to use or not to use cytisine and/or e-cigarettes in their quit attempt.
- •Have a history of severe allergy and/or poorly controlled asthma.
研究组 & 干预措施
Monotherapy (Cytisine only)
12 weeks of cytisine: Participants allocated cytisine will be instructed to follow the manufacturer's 25-day dosing regimen, then follow a maintenance dose of cytisine from day 26 to week 12. Participants will also receive six months of text-based smoking cessation support.
干预措施: Cytisine (Drug)
Monotherapy (Nicotine e-cigarette only)
12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.
干预措施: Nicotine delivered via an e-cigarette (Drug)
Combination therapy (Cytisine plus a nicotine e-cigarette)
12 weeks of cytisine (as above) and 12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.
干预措施: Cytisine plus nicotine delivered via an e-cigarette (Combination Product)
结局指标
主要结局
Proportion of participants with verified continuous smoking abstinence
时间窗: Six months post-quit date
Defined as self-report of smoking not more than five cigarettes from the Quit date (day 0) and confirmed by standardized exhaled carbon-monoxide (CO) measurement with a Bedfont Smokerlyzer, (≤9 ppm signifying abstinence). Sensitivity analysis will be undertaken looking at different cut-offs for the CO measurement, given lack of consensus about the best reading to use.
次要结局
- Gender(Assessed at baseline)
- Ethnicity (self-reported)(Assessed at baseline)
- Number of cigarettes smoked per day(Assessed at baseline)
- Time taken to smoke the contents of a pack or pouch(Assessed at baseline)
- Education(Assessed at baseline)
- Age started smoking(Assessed at baseline)
- Number of years of continuous smoking(Assessed at baseline)
- Median pack size (Factory-made cigarettes)(Assessed at baseline)
- Self-reported continuous smoking abstinence(Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Time to first lapse back to smoking by participants(Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Time to first relapse back to smoking by participants(Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Proportion of participants who use other smoking cessation methods(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Age(Assessed at baseline)
- Methods used in previous quit attempt(Assessed at baseline)
- Cannabis use(Assessed at baseline)
- Type of cigarettes smoked(Assessed at baseline)
- Mean pack size (Factory-made cigarettes)(Assessed at baseline)
- Mean pouch size (Roll your-own tobacco)(Assessed at baseline)
- Median pouch size (Roll your-own tobacco)(Assessed at baseline)
- At least one quit attempt in the past 12 months(Assessed at baseline)
- Time quit, for last quit attempt(Assessed at baseline)
- Living with other people who smoke tobacco(Assessed at baseline)
- Living with other people who use nicotine e-cigarettes (vapes)(Assessed at baseline)
- Reduction in smoking by participants(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Reasons for not using allocated treatment(Measured at quit date (day 0), then at one month post quit date.)
- Treatment switching (crossover from e-cigarette-only to cytisine): source of cytisine(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Reduction in the number of cigarettes smoked in the past 12 months(Assessed at baseline)
- Motivation to quit(Assessed at baseline)
- Chances of giving up smoking(Assessed at baseline)
- Self-reported 7-day point prevalence smoking abstinence(Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in the number of cigarettes smoked per day (if smoking) by participants(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Health-related quality of life (five domains)(Assessed at baseline, three, six and 12 months post-quit date)
- Participant compliance with cytisine use(Measured at three months post quit date.)
- Frequency of use of the e-cigarette, by participants allocated e-cigarettes(Measured at three months post quit date.)
- Level of cigarette dependence(Assessed at baseline)
- Has close friends who use nicotine e-cigarettes (vapes)(Assessed at baseline)
- Alcohol use(Assessed at baseline)
- Health-related quality of life (self-rated health)(Assessed at baseline, three, six and 12 months post-quit date)
- Daily use of the allocated treatment by participants(Measured at quit date (day 0), then at one month post quit date.)
- Treatment switching (crossover from cytisine-only to e-cigarette)(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Acceptability of allocated product(Measured at three months post-quit date (end of treatment))
- Number of participants with self-reported adverse events(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Number of cytisine tablets taken by participants(Measured at one and three months post quit date.)
- Number of nicotine pods used, by participants allocated e-cigarettes(Measured at one and three months post quit date.)
- Treatment switching (crossover from cytisine-only to e-cigarette): nicotine content of e-cigarette(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Treatment switching (crossover from e-cigarette-only to cytisine)(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in severity of mental health concerns, in those participants with mental health concerns.(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Continuation of product use by participants(Measured at six (in all) and 12 months (in a subsample).)
- Participants recommendations regarding the allocated product(Measured at three months post-quit date (end of treatment))
- Change from baseline in frequency of coughing in participants(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Marginal cost per quitter(Assessed at six months)
- Signs and symptoms of nicotine withdrawal in participants(Measured at baseline and at three months (end of treatment).)
- Urge to smoke in participants(Measured at baseline and at three months (end of treatment).)
- Change in e-cigarette use(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Dual use of treatment and tobacco by participants(Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in body mass index(Asked at three and six months post-quit date)
- Change from baseline in severity of Chronic Obstructive Pulmonary Disease (COPD), in those participants with COPD.(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Mean number of text-based behavioral support messages received by participants(Assessed at six months)
- Number of self-reported adverse events(Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in frequency of shortness of breath in participants(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in asthma severity, in those participants with asthma(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Change from baseline in severity of chronic pain, in those participants with chronic pain.(Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample))
- Concomitant medication(Assessed at baseline, quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample))
- Median number of text-based behavioral support messages received by participants(Assessed at six months)
研究者
Natalie Walker
Associate Professor in Population Health
University of Auckland, New Zealand