To examine how well Baclofen and Naltrexone work as medications in individuals with alcohol addiction and withdrawal symptoms.

Phase 3

• Conditions: Health Condition 1: F102- Alcohol dependence

• Registration Number: CTRI/2024/06/069491
• Lead Sponsor: Rahul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Aged 18 to 60 years

2. Alcohol Dependence according to the DSM-5-TR

3.JELLINEK’s alcoholic type gamma, delta and epsilon e type

4.Adequate cognition and language skills to give valid consent and to complete research interviews

5.Written informed consent

6. Written informed consent for naltrexone, if applicable

Exclusion Criteria

1.Active major psychiatric disorder except alcohol dependence

2.Pregnancy or lactating women

3.Dependence on other substances except alcohol and nicotine

4. Opioid abuse, opioid dependence or opioid agonist treatment, or likely need for opioid treatment

5. Any evidence of alcoholic cirrhosis or advanced fibrosis, either clinically or through relevant investigations including fibroscan

6.Lack of stable housing or contact phone number

7.Previous hypersensitivity to baclofen or naltrexone

8.Any pharmacotherapy related to alcohol dependence or ALD before enrolment

9.Contra-indications for baclofen treatment were uncontrolled epilepsy, patent hepatic encephalopathy, and renal failure

10. Contra-indication for naltrexone – Acute/ Fulminant liver failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy – <br/ ><br>1.Abstinence – Number of non drinking days <br/ ><br>2.Time to lapse <br/ ><br>3.Time to relapse (if present) <br/ ><br>1-3 Assessed by TLFB scale <br/ ><br>4.Craving Assessed by OCDS and VASC scale <br/ ><br>5. Decreased CIWA-Ar score after lapse / relapse <br/ ><br>Safety – <br/ ><br>Hepatic impairment assessed by serial LFTsTimepoint: 1 month <br/ ><br>2 months <br/ ><br>3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Prognostic scoring of Alcoholic Liver Disease by Maddrey Discriminant function (MDf) <br/ ><br>Decreased alcohol related hospitalization <br/ ><br>Adverse events reported as per CDSCO Central Drugs Standard Control Organization reporting formTimepoint: Follow up assessment for secondary outcomes will be done at baseline 1 month 2 months 3 months 6 months