Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects

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.

Study Overview

• Status: Unknown
• Conditions: Drug Abuse
• Intervention / Treatment: Drug: Opipramol; Drug: Baclofen

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Paola Roska, MD; Phone Number: 972-2-5080645; Email: paola.roska@MOH.GOV.IL
• Study Contact Backup: Name: Keren Goldman, MsC; Phone Number: 972-2-5080650; Email: keren.goldman@moh.gov.il

Study Locations

• Israel
  • Bet Shemesh, Israel
    • Recruiting
    • Retorno rehabilitation center
    • Contact: Eitan Eckstein; Phone Number: 9-73-210439; Email: eitan@retorno.org
    • Contact: Shira Eckstein; Phone Number: 972-2-5318123; Email: shiraeckbiu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Opipramol; PO; Drug: Baclofen; PO
Active Comparator: 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.	Drug: Opipramol; PO; Drug: Baclofen; PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased craving	Lower withdrawal symptom will be measured by questionnaires	1 month

Collaborators and Investigators

• Sponsor: Ministry of Health, Israel
• Investigators: Principal Investigator: Gal Yadid, PhD, Bar Ilan University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; GABA Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Adrenergic Uptake Inhibitors; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen; Opipramol
• Other Study ID Numbers: 066-2017 MOH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No