Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Ministry of Health, Israel

Status and phase: Unknown; Early Phase 1

Conditions: Drug Abuse

Treatments: Drug: Opipramol; Drug: Baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03065998

066-2017 MOH

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Drug-A

Active Comparator group

Description:

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.

Treatment:

Drug: Baclofen

Drug: Opipramol

Drug-B

Active Comparator group

Description:

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.

Treatment:

Drug: Baclofen

Drug: Opipramol