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

To study the efficacy and safety of Baclofen versus Baclofen and Naltrexone as Anticraving agents in patients of Alcohol Dependence with Alcoholic Liver Disease - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069491

Enrollment

150

Registered

2024-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: TO STUDY THE EFFICACY AND SAFETY OF BACLOFEN VERSUS BACLOFEN AND NALTREXONE AS ANTICRAVING AGENTS IN PATIENTS OF ALCOHOL DEPENDENCE WITH ALCOHOLIC LIVER DISEASE: In one group drug is co

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Prognostic scoring of Alcoholic Liver Disease by Maddrey Discriminant function (MDf) Decreased alcohol related hospitalization 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	—

Countries

India

Contacts

Public ContactDr Rohit Garg

Baba Farid University of Health Sciences

profheadpsy@yahoo.com9463323686

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026