Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Percent Abstinent Days
研究概览
简要总结
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
详细描述
Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
- •Seeking treatment with the aim to stop alcohol consumption;
- •Age ranging from 18 to 60 years;
- •Last alcohol intake reported in the 24 h preceding observation;
- •Presence of a referred family member;
- •Written informed consent provision.
排除标准
- •Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
- •Suicide risk, acute psychosis, severe depression, organic brain syndromes;
- •Dependence on psychoactive substances other than nicotine.
研究组 & 干预措施
Baclofen
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
干预措施: Baclofen (Drug)
Psychosocial intervention
Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
干预措施: Control group (Other)
结局指标
主要结局
Percent Abstinent Days
时间窗: one year
Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
次要结局
- Obsessive-Compulsive Drinking Scale Scores(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- General Health Questionnaire(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- General Self-Efficacy Scale(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Multidimensional Scale of Perceived Social Support(Baseline, 52 weeks)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
研究者
Alexander Grinshpoon
Dr. Alexander Grinshpoon
Sha'ar Menashe Mental Health Center