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临床试验/NCT03065998
NCT03065998Unknown早期 1 期

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects

Ministry of Health, Israel1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

研究者

发起方
Ministry of Health, Israel
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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