Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFebruary 28, 2017
January 1, 2017
10 months
February 14, 2017
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Decreased craving
Lower withdrawal symptom will be measured by questionnaires
1 month
Study Arms (2)
Drug-A
ACTIVE COMPARATORopripramol 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
ACTIVE COMPARATORbaclofen 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials
You may not qualify if:
- Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retorno rehabilitation center
Bet Shemesh, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gal Yadid, PhD
Bar Ilan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 28, 2017
Study Start
March 1, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
February 28, 2017
Record last verified: 2017-01