Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
研究概览
简要总结
It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery. The company has focused on nicotine withdrawal in smoking cessation,as primary target.
详细描述
A randomized,double-blind, dose-finding,phase IIB study with Libertal has been performed in 493 volunteer smokers, wishing to quit. They were divided into 5 arms: 4 treatment groups of 0.5, 1.0, 2.0 and 4.0g/day respectively, and one placebo, divided BID. Treatment was administered during one week prior to smoking cessation, then continued during 8 weeks (56 days), followed by another 4 weeks without treatment (up to day 84). The primary endpoint was complete smoking cessation during at least 28 consecutive days. There were 6 on-site visits and 4 telephone interviews.
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
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
- •Smokers of at least 1 year duration
- •Smoking at least 10 cigarettes/day
- •Having failed at least one previous smoking cessation effort.
- •Without a major cardio-vascular or metabolic disease or condition.
排除标准
- •An uncontrolled major cardiovascular, metabolic, or other condition condition.
- •Need for surgery during the period of participation in the trial.
- •Any treatment for smoking cessation during the 2 months preceding enrollment in the present trial.
结局指标
主要结局
Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
次要结局
- Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants