drugset / Trial / NCT03065998

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

NCT03065998

Phase 0 Unknown 140 enrolled Ministry of Health, Israel
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-03
Primary completion
2018-01
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Baclofen Small molecule 90 mg
Comparator Opipramol Small molecule 150 mg

Indications