Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Continuous abstinence
研究概览
简要总结
SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.
Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.
Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.
Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.
Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).
Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.
Expected benefits: This study might contribute to optimize the current use of varenicline.
详细描述
Study design:
The study is a parallel group, double-blind, randomised controlled clinical trial. Allocation to treatment will be made when the subject has been entered into the study that is when he/she has fulfilled the inclusion/exclusion criteria (see below). Visits will be arranged at inclusion, at week 4 and 6 (Quit day (QD)) after inclusion, and at week 1, 6, 12, and 24 after QD.
Study population:
Participants will be eligible smokers from throughout Jerusalem, who want to reduce then stop smoking.
Randomisation procedure:
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, Care Provider, 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
- •Men or women aged ≥18 years
- •Currently smoking 10 cigarettes per day or more
- •Having smoked 5 py or more
- •Presenting a CO level in expired air ≥ 10 ppm
- •Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements
- •Willing to sign a statement of informed consent
排除标准
- •Myocardial infarction within the last 3 months
- •Unstable angina
- •Severe cardiac arrhythmia
- •Pregnancy or breast feeding
- •Use of any form of smokeless tobacco or nicotine substitution
- •Having followed any smoking cessation programme during the last 3 months
- •Alcohol or other drug addiction
- •Use of any form of smokeless tobacco or nicotine substitution
- •Participation in any clinical trial within the past 3 months
- •Women in childbearing age not willing to use contraception until week 12 after QD
研究组 & 干预措施
group A
Subjects in Group A will receive varenicline for six weeks .During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
干预措施: Varenicline (Drug)
group B
group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
干预措施: Varenicline (Drug)
group B
group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
干预措施: placebo (Drug)
结局指标
主要结局
Continuous abstinence
时间窗: from week 7 until week 24
defined as avoidance of tobacco (not a single puff) since the quit date. It will be assessed by self-reported complete abstinence and expired CO \< 10 ppm from week 7 until endpoint. The occurrence of occasional lapses after week 7 will be categorised as a failure in the main evaluation, but will not necessitate withdrawal if the subject is willing to continue and is considered by the investigators as competent to succeed.
次要结局
- adverse events(from week 7 until week 24)
- smoking reduction(from week 7 until week 24)
- Decline in pulmonary function(from week 7 until week 24)
- Symptoms and physical signs associated with withdrawal: MPSS questionnaire(from week 7 until week 24)
- Use of cigarettes(from week 7 until week 24)