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Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Primary Purpose

Drug Abuse

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Opipramol
Baclofen
Sponsored by
Ministry of Health, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Retorno rehabilitation centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Drug-A

Drug-B

Arm 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.

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.

Outcomes

Primary Outcome Measures

Decreased craving
Lower withdrawal symptom will be measured by questionnaires

Secondary Outcome Measures

Full Information

First Posted
February 14, 2017
Last Updated
February 22, 2017
Sponsor
Ministry of Health, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT03065998
Brief Title
Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction
Official Title
Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2017 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ministry of Health, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug-A
Arm Type
Active Comparator
Arm 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.
Arm Title
Drug-B
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Opipramol
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
PO
Primary Outcome Measure Information:
Title
Decreased craving
Description
Lower withdrawal symptom will be measured by questionnaires
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Roska, MD
Phone
972-2-5080645
Email
paola.roska@MOH.GOV.IL
First Name & Middle Initial & Last Name or Official Title & Degree
Keren Goldman, MsC
Phone
972-2-5080650
Email
keren.goldman@moh.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gal Yadid, PhD
Organizational Affiliation
Bar Ilan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retorno rehabilitation center
City
Bet Shemesh
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eitan Eckstein
Phone
9-73-210439
Email
eitan@retorno.org
First Name & Middle Initial & Last Name & Degree
Shira Eckstein
Phone
972-2-5318123
Email
shiraeckbiu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

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