Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rating of urges to smoke 1-week after the target quit
研究概览
简要总结
Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. The downside of this cautious approach is that a substantial proportion of clients may be under-dosed. A blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy.
This study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. These smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.
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
- •Smoker seeking treatment
- •Aged 18 and over
- •Consenting to take part
- •Report little or no change in enjoyment of cigarettes and/or nausea
排除标准
- •Pregnant or breastfeeding
- •Have severe kidney disease
- •Have severe heart problems
- •Have a current psychiatric illness
- •Are unable to fill in questionnaires in English
- •Have an allergy to varenicline
- •Are currently involved in another clinical trial
研究组 & 干预措施
Varenicline + Active Tailored Dose
干预措施: Varenicline (Drug)
Varenicline + Placebo Tailored Dose
干预措施: Placebo (Drug)
Varenicline + Placebo Tailored Dose
干预措施: Varenicline (Drug)
结局指标
主要结局
Rating of urges to smoke 1-week after the target quit
时间窗: 1 week
Rating of urges to smoke will be assessed using the Mood \& Physical Symptoms Scale
次要结局
- Rating of urges to smoke 24 hours post target quit date(24 hours post target quit date)
- Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date(2 weeks pre quitting)
- The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale(4 weeks post quitting)
- Validated abstinence rates at 1-12 weeks post target quit date(1-12 weeks post target quit date)
- Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting(Up to 12 weeks post quitting)
- Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen(Up to 12 weeks post quit)
研究者
Dr. Al-Rehan Abdul Aziz Dhanji
Clinical Fellow in Cardiothoracic Surgery
Queen Mary University of London