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

NCT ID: NCT04391764

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-06
• Study Completion Date: 2022-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Naltrexone

Naltrexone at a dose of 50 mg per day.

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Naltrexone at a dose of 50 mg per day

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Naltrexone

Naltrexone at a dose of 50 mg per day

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.

2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

Exclusion Criteria

1. Current Hepatic Encephalopathy

2. Total Bilirubin > 3 mg/dl.

3. Recent bleed.

4. Treatment with corticosteroids within the past 60 days.

5. Unwilling to participate.

6. Dependence on any other substance (except Nicotine).

7. Psychotic disorder requiring treatment/Suicidal tendency.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-Cirrhosis-28

Identifier Type: -

Identifier Source: org_study_id