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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391764
• Other study ID #: ILBS-Cirrhosis-28
• Status: Completed
• Phase: N/A
• Start date: December 6, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Naltrexone
Naltrexone at a dose of 50 mg per day
• Placebo oral tablet
Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups		12 weeks
Secondary	Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo		12 weeks
Secondary	Proportion of patients maintaining abstinence from alcohol at 6 months in both groups		6 months
Secondary	Proportion of patients maintaining abstinence from alcohol at 12 months in both groups		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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