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

Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Naltrexone; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Manasa Alla, MD; Phone Number: 01146300000; Email: manasa1512@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naltrexone; Naltrexone at a dose of 50 mg per day.	Drug: Naltrexone; Naltrexone at a dose of 50 mg per day
Placebo Comparator: Placebo; Placebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner.	Drug: Placebo oral tablet; Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving	4 weeks
difference in craving measures between both groups at 8 weeks.	OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving	8 weeks
difference in craving measures between both groups at 12 weeks.	OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving	12 weeks
difference in craving measures between both groups at 6 months.	OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving	6 months
difference in craving measures between both groups at 12 months.	OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving	12 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: ILBS-Cirrhosis-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No