Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Decreased craving
研究概览
简要总结
The aim of this study is examining the combination of two FDA approved drugs, Opipramol and baclofen, which may increase rehabilitation from psychoactive substances. Previous studies have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility that these receptors as mediators of drug craving . However previous studies showed partial efficacy with no significant relapse in relapse rates. The same is true for the use of GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal model for addiction have shown a significant effect of the combine treatment of the indicated medications both in decreasing relapse and increase of -number of respondents.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials
排除标准
- •Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).
研究组 & 干预措施
Drug-A
opripramol 150 mg per day (3*50) Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent.
干预措施: Opipramol (Drug)
Drug-A
opripramol 150 mg per day (3*50) Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent.
干预措施: Baclofen (Drug)
Drug-B
baclofen 90 mg per day (3*30) Baclofen is a GABAb-1 antagonist and has shown partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine.
干预措施: Baclofen (Drug)
Drug-B
baclofen 90 mg per day (3*30) Baclofen is a GABAb-1 antagonist and has shown partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine.
干预措施: Opipramol (Drug)
结局指标
主要结局
Decreased craving
时间窗: 1 month
Lower withdrawal symptom will be measured by questionnaires
次要结局
未报告次要终点
