Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Target population
研究概览
简要总结
Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.
The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.
详细描述
Numerous centers of the French research group of the national association of the hepatologists and gastroenterologists from general hospitals (ANGH) will be part of this study. Patients treated with baclofen for alcohol -dependence will be enroll prospectively from 2014 and retrospectively if they were treated between 2012 and 2014. The reported alcohol consumption, biological markers of excessive alcohol, initial and usual baclofen dosage, blood balofen dosage as well as clinical data will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 older than 18 years old
- •patient treated with baclofen therapy after 2012 for alcoholo-dependance
排除标准
- •Baclofen therapy before 2012
- •patient who refuse to participate
结局指标
主要结局
Target population
时间窗: at inclusion
Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.
次要结局
- Biological markers of alcohol consumption(at inclusion, at 3, 6 and 12 months of follow-up)
- Baclofen dosage(at 3, 6 and 12 months of follow-up)
- baclofen posology(at inclusion, at 3, 6 and 12 months of follow-up)
- baclofen tolerance(at 3, 6 and 12 months of follow-up)
- Alcohol consumption(at inclusion, at 3, 6 and 12 months of follow-up)
研究者
Camille Barrault
Dr
Centre Hospitalier Intercommunal Creteil