Clinical Trials Logo
  1. Home
  2. Drug Abuse
  3. NCT03065998
  4. Details
NCT03065998 Clinical Trial

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Drug Abuse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03065998
Other study ID # 066-2017 MOH
Secondary ID
Status Recruiting
Phase Early Phase 1
First received February 14, 2017
Last updated February 22, 2017
Start date March 2017
Est. completion date January 2019

Study information
Verified date January 2017
Source Ministry of Health, Israel
Contact Paola Roska, MD
Phone 972-2-5080645
Email paola.roska@MOH.GOV.IL
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date January 2019
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Opipramol
PO
• Baclofen
PO

Locations
Country Name City State
Israel Retorno rehabilitation center Bet Shemesh

Sponsors (1)
Lead Sponsor Collaborator
Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decreased craving Lower withdrawal symptom will be measured by questionnaires 1 month
See also
  Status Clinical Trial Phase
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT02375516 - Preventing Drug Abuse Among Hispanic Adolescents N/A
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT00907309 - Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use Phase 1/Phase 2
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Withdrawn NCT01427465 - Brief Integrative Alcohol Interventions for Adolescents N/A
Completed NCT00350909 - Brief Intervention for Drug Abusing Adolescents Phase 2
Completed NCT00148031 - Improving Hepatitis C Treatment in Injection Drug Users Phase 4
Completed NCT00383838 - Self-Selected Brief Alcohol Intervention for Adolescents N/A
Completed NCT00722644 - Cognitive Behavioral Stress Management for HIV+ Drug Abusers Phase 1
Completed NCT00451854 - Student Athlete Testing Using Random Notification N/A
Completed NCT01036711 - Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI
Terminated NCT02741076 - Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain Phase 4
Completed NCT01035723 - Effect of Functional Genetic Polymorphisms on Brain Morphology and Function
Completed NCT06044363 - Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders N/A
Recruiting NCT05037487 - Evaluation of Smoked THC and CBD in Men and Women Phase 1
Recruiting NCT04725266 - A Family-based Intervention for Drug-abusing Adults in Hong Kong N/A
Completed NCT03678051 - CBT4CBT for Women in Residential Treatment for Substance Use Disorders N/A