NCT01738282已完成3 期
A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ethypharm
- 入组人数
- 316
- 试验地点
- 19
- 主要终点
- Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
研究概览
简要总结
The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.
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
- •Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence
- •Willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal
- •Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days
- •At least one previous abstinence attempt
排除标准
- •Need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction
- •Need for a heavy psychosocial out of hospital care
- •History of baclofen intake, by prescription or self medication
- •Porphyria
- •Concomitant treatment with one or several drugs for the maintenance of abstinence
- •Severe renal, cardiac or pulmonary disorder
- •Epilepsy or history of epilepsy
- •Concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam
- •Severe psychiatric disease (schizophrenia and bipolar disorder)
- •Suicidal risk or history of suicide
- •Clinically significant cognitive disorders
- •Hepatic encephalopathy
- •Ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs...), excepted tobacco
研究组 & 干预措施
Baclofen
Experimental
Baclofen 20mg tablet. Titration:increasing dosage regimen to reach the target dosage of 180 mg (9 tablets)in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
干预措施: Baclofen (Drug)
Placebo
Placebo Comparator
Placebo tablet Titration:increasing dosage regimen to reach the target dosage of 9 tablets in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks
干预措施: Placebo (for baclofen) (Drug)
结局指标
主要结局
Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168.
时间窗: Day 168
次要结局
- Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of 4-week post treatment follow up period (Day 210), i.e. 30 weeks(Day 210)
- Drinking characteristics for patients having a relapse between Day 1 and Day 210(Day 210)
- Change in craving, addiction and Quality of Life scales(Day 210)
- Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of the maintenance dose period (Day 168), i.e. 24 weeks(Day 168)
- Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence(Day 168)
- Recording of safety data(Day 210)
- Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the level of drinking before withdrawal (Time Line Follow Back calendar/ World Health Organization criteria for risk of consumption)(Day 168)
研究者
研究点 (19)
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