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Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

NCT ID: NCT03065998

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Drug Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Drug-A

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.

Group Type ACTIVE_COMPARATOR

Opipramol

Intervention Type DRUG

PO

Baclofen

Intervention Type DRUG

PO

Drug-B

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.

Group Type ACTIVE_COMPARATOR

Opipramol

Intervention Type DRUG

PO

Baclofen

Intervention Type DRUG

PO

Interventions

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Opipramol

PO

Intervention Type DRUG

Baclofen

PO

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gal Yadid, PhD

Role: PRINCIPAL_INVESTIGATOR

Bar Ilan University

Locations

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Retorno rehabilitation center

Bet Shemesh, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Paola Roska, MD

Role: CONTACT

Phone: 972-2-5080645

Email: [email protected]

Keren Goldman, MsC

Role: CONTACT

Phone: 972-2-5080650

Email: [email protected]

Facility Contacts

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Eitan Eckstein

Role: primary

Shira Eckstein

Role: backup

Other Identifiers

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066-2017 MOH

Identifier Type: -

Identifier Source: org_study_id