A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit
研究概览
简要总结
Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.
The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.
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
- Double (Participant, 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
- 否
入选标准
- •Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.
排除标准
- •Patients with a limited level of motivation.
- •Other participant in a household enrolled in the study.
- •Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
- •Patients dependent to alcohol or illicit drugs.
- •Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
- •Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
- •Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
研究组 & 干预措施
1
干预措施: placebo (Drug)
2
surinabant 2,5 mg/day
干预措施: surinabant (SR147778) (Drug)
3
surinabant 5 mg/day
干预措施: surinabant (SR147778) (Drug)
4
surinabant 10 mg/day
干预措施: surinabant (SR147778) (Drug)
结局指标
主要结局
Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit
时间窗: during the last four weeks of treatment
次要结局
- Change from baseline in total body weight(8 weeks)
- Total score of the Questionnaire of Smoking Urges(8 weeks)
- Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events)(14 weeks)