Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Early Phase 1

• Conditions: Drug Abuse
• Interventions: Drug: Opipramol; Drug: Baclofen

• Registration Number: NCT03065998
• Lead Sponsor: Ministry of Health, Israel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28
• Study Start: 2017-03
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials

Exclusion Criteria

• Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-B	Opipramol	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.
Drug-A	Opipramol	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.
Drug-A	Baclofen	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.
Drug-B	Baclofen	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.

Primary Outcome Measures

Name	Time	Method
Decreased craving	1 month	Lower withdrawal symptom will be measured by questionnaires

Trial Locations

Locations (1)

Retorno rehabilitation center; 🇮🇱 Bet Shemesh, Israel