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Completed

NCT Number: NCT04391764

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone

Drug

Naltrexone at a dose of 50 mg per day

Placebo oral tablet

Drug

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

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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