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

• ClinicalTrials.gov Identifier: NCT04391764
• Recruitment Status: Completed
• First Posted: May 18, 2020
• Last Update Posted: March 28, 2023
• Sponsor: Institute of Liver and Biliary Sciences, India
• Information provided by (Responsible Party): Institute of Liver and Biliary Sciences, India

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Liver Cirrhosis	Drug: Naltrexone; Drug: Placebo oral tablet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.
• Actual Study Start Date: December 6, 2020
• Actual Primary Completion Date: October 31, 2022
• Actual Study Completion Date: October 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo [ Time Frame: 12 weeks ]
2. Proportion of patients maintaining abstinence from alcohol at 6 months in both groups [ Time Frame: 6 months ]
3. Proportion of patients maintaining abstinence from alcohol at 12 months in both groups [ Time Frame: 12 months ]
4. difference in craving measures between groups at 4 weeks in both groups [ Time Frame: 4 weeks ]
   OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
5. difference in craving measures between both groups at 8 weeks. [ Time Frame: 8 weeks ]
   OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
6. difference in craving measures between both groups at 12 weeks. [ Time Frame: 12 weeks ]
   OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
7. difference in craving measures between both groups at 6 months. [ Time Frame: 6 months ]
   OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
8. difference in craving measures between both groups at 12 months. [ Time Frame: 12 months ]
   OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving

Eligibility Criteria

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

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.

Contacts and Locations

Locations

India

Institute of Liver and Biliary Sciences

New Delhi, Delhi, India, 110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

More Information

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT04391764
• Other Study ID Numbers: ILBS-Cirrhosis-28
• First Posted: May 18, 2020
• Last Update Posted: March 28, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Naltrexone; Alcohol Deterrents; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents