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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |