Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.

NCT04391764 | Completed

• 1 other identifier: ILBS-Cirrhosis-28
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality. All ALD patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. In case of any reactions, the drug will be stopped as per the study stopping rule. After following the inclusion and exclusion criteria, ALD patients will be recruited into the study. It's a double blind RCT, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste. Naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups

  12 weeks

Secondary Outcomes (8)

• Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo

  12 weeks

• Proportion of patients maintaining abstinence from alcohol at 6 months in both groups

  6 months

• Proportion of patients maintaining abstinence from alcohol at 12 months in both groups

  12 months

• difference in craving measures between groups at 4 weeks in both groups

  4 weeks

• difference in craving measures between both groups at 8 weeks.

  8 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

Naltrexone at a dose of 50 mg per day.

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Placebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner.

Drug: Placebo oral tablet

Interventions

Naltrexone DRUG

Naltrexone at a dose of 50 mg per day

Naltrexone

Placebo oral tablet DRUG

Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
• Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

You may not qualify if:

• Current Hepatic Encephalopathy
• Total Bilirubin \> 3 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/Suicidal tendency.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 18, 2020
• Study Start: December 6, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

IN (1)