2024-518135-10-00招募中3 期
A randomized, placebo controlled, double blind, double dummy, multicenter trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine. ECSMOKE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 14
- 主要终点
- Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
研究概览
简要总结
To assess the efficacy of electronic cigarettes containing nicotine (ECwN) comparatively to an EC without nicotine (ECwoN) and to a reference, licensed smoking cessation medication: varenicline.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
- •Aged 18 to 70 years
- •Motivated to quit defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
排除标准
- •any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments, such as : see protocol
- •any life threatening condition with life-expectancy of less than 3 months
- •alcohol use disorder defined as a score ? 10 on the AUDIT-C questionnaire
- •abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
- •regular use of tobacco products other than cigarettes
- •current or previous (last 6 months) use of electronic cigarette
- •pregnant women
- •breastfeeding women
结局指标
主要结局
Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
次要结局
- The assessment criterion of the safety will be the comparison of serious adverse events and non-serious adverse events
- Point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm.
- Time to relapse to smoking after the predefined target quit day
- Change in cigarettes/day consumption
- Change in craving for tobacco
- Change in withdrawal symptoms
研究者
Dr Ivan Berlin
Scientific
Assistance Publique Hopitaux De Paris
研究点 (14)
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