Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
研究概览
简要总结
Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target 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
- •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
- •Unable to fill in questionnaires in English
- •Previous allergy to Varenicline
- •Previous allergy to Nicotine Patches Previous allergy to varenicline
研究组 & 干预措施
Varenicline + Active Patch
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
干预措施: Nicotine Patch (Drug)
Varenicline + Active Patch
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
干预措施: Varenicline (Drug)
Varenicline + Placebo Patch
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
干预措施: Placebo (Drug)
Varenicline + Placebo Patch
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
干预措施: Varenicline (Drug)
结局指标
主要结局
Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
时间窗: 1 week
Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale
次要结局
- Validated abstinence rates over weeks 1-12 post target quit date(12 weeks post target quit date)
- Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale(4-weeks post quitting)
- Profile of all adverse effects reported up to 12-weeks post quitting(Up to 12-weeks post quitting)
- Ratings of urges to smoke 24 hours after the target quit date(24 hours)
研究者
Professor Peter Hajek
Professor of Clinical Psychology
Queen Mary University of London