A COMPARATIVE STUDY OF NALTREXONE, BACLOFEN AND NALTREXONE-BACLOFEN COMBINATION IN PATIENT WITH ALCOHOL DEPENDENCE

Phase 3

• Conditions: Health Condition 1: F102- Alcohol dependence

• Registration Number: CTRI/2023/03/050775
• Lead Sponsor: King Georges Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Diagnosis of alcohol dependence as per International Classification of Diseases 11th Revision (ICD-11)

2. Age between 18 and 60 years,

3. Complete abstinence for at least 10 days

4. Total Clinical Institute Withdrawal Assessment for Alcohol revised version (CIWA-Ar) score less than 8, with not more than one score on any of the items.

Exclusion Criteria

1. A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorder

2. Current use of any psychotropic medication (except Trazodone)

3. Evidence of severe neurologic or physical disorders

4. History of cirrhosis or laboratory evidence of significant hepatocellular injury

5. Pregnancy, nursing, or refusal to use a reliable method of birth control in women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The patient of alcohol dependence treated with naltrexone-baclofen combination expected to have less craving, episodes of heavy alcohol use, and relapse rate compared to the of naltrexone alone and baclofen alone.Timepoint: Baseline,2 week ,4 week ,8 week from baseline