Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
研究概览
简要总结
Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.
The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.
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
- •Smokers seeking treatment
- •Aged 18 and over
- •Consenting to take part in the trial
排除标准
- •Pregnant or breastfeeding
- •End-stage renal disease
- •Used varenicline in the past 6 months
- •Unable to fill in questionnaires in English
- •Current psychiatric illness
- •Current serious illness including uncontrolled hypertension and recent cardiac event
- •Sensitivity to varenicline currently enrolled in other research projects.
研究组 & 干预措施
Varenicline pre-treatmemt
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
干预措施: Varenicline (Drug)
Placebo
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
干预措施: Varenicline (Drug)
Placebo
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
干预措施: Placebo (Drug)
结局指标
主要结局
Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
时间窗: 24 hours and 7 days after quit date (week 4)
The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.
次要结局
- Change in Pre-quit End-expired Carbon Monoxide Reading (CO)(Baseline - week 8)
- Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence(Week 4 - 8)
- Change in Pre-quit Cotinine Levels(Weeks 1-4 (the first 4-weeks after first medication dose))
- Change in Pre-quit Ratings of Cigarette Satisfaction(Baseline - week 4)
- Change in Pre-quit Cigarette Consumption(Baseline - week 4)
研究者
Professor Peter Hajek
Professor of Clinical Psychology
Queen Mary University of London