Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

NCT06175507 | Unknown

• 1 other identifier: ILBS-ALD-02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.

Conditions

Alcohol Liver Disease

Outcome Measures

Primary Outcomes (1)

• The comparison in the proportion of patients achieving and maintaining alcohol abstinence between Naltrexone and Baclofen in alcohol associated liver cirrhosis patients with continued alcohol intake at 12 weeks

  12 weeks

Secondary Outcomes (6)

• To evaluate abstinence rate by OCDS score in both the group (OCDS- Obsessive compulsive drinking scale 0-40, Higher total score indicate more obsessive thoughts or compulsive behaviour regarding alcohol use)

  4 weeks

• To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks

  24 weeks

• To evaluate difference in craving measures between groups at 4,8,12 and 24 weeks.

  4, 8,12 and 24 weeks

• To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks

  4, 8,12 and 24 weeks

• To evaluate proportion of patients developing lapse and relapse in both the group at 4,8,12 and 24 weeks

  4,8,12 and 24 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

Naltrexone 50mg orally once daily will give for 12 weeks

Drug: Naltrexon

Baclofen

ACTIVE COMPARATOR

Baclofen 10mg orally thrice daily will give for 12 weeks

Drug: Baclofen

Interventions

Naltrexon DRUG

Naltrexone 50mg orally once daily will give for 12 weeks

Naltrexone

Baclofen DRUG

Baclofen 10mg orally thrice daily will give for 12 weeks

Baclofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
• Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
• History of recent recidivism / relapse

You may not qualify if:

• Current HE
• Total Bilirubin \> 5 mg/dl
• Recent bleed
• Treatment with corticosteroids within the past 60 days
• Unwilling to participate
• Dependence on any other substance (except Nicotine)
• Psychotic disorder requiring treatment

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Naltrexone; Baclofen

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Dr Ravi Nishad, MD

CONTACT

01146300000; ravinishad.422@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 19, 2023
• Study Start: December 25, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-10

Locations

IN (1)