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

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Naltrexone
Placebo oral tablet
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone

Placebo

Arm Description

Naltrexone at a dose of 50 mg per day.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2020
Last Updated
March 27, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04391764
Brief Title
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.
Official Title
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Naltrexone at a dose of 50 mg per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Naltrexone at a dose of 50 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.
Primary Outcome Measure Information:
Title
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo
Time Frame
12 weeks
Title
Proportion of patients maintaining abstinence from alcohol at 6 months in both groups
Time Frame
6 months
Title
Proportion of patients maintaining abstinence from alcohol at 12 months in both groups
Time Frame
12 months
Title
difference in craving measures between groups at 4 weeks in both groups
Description
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Time Frame
4 weeks
Title
difference in craving measures between both groups at 8 weeks.
Description
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Time Frame
8 weeks
Title
difference in craving measures between both groups at 12 weeks.
Description
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Time Frame
12 weeks
Title
difference in craving measures between both groups at 6 months.
Description
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Time Frame
6 months
Title
difference in craving measures between both groups at 12 months.
Description
OCDS (Obsessive-Compulsive Drinking Scale) scale will be use to measure the craving
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consecutive alcohol dependent cirrhotic aged between 18-60 yrs. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013). Exclusion Criteria: 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.
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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