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

Tracking Information

• First Submitted Date: May 8, 2020
• First Posted Date: May 18, 2020
• Last Update Posted Date: March 28, 2023
• Actual Study Start Date: December 6, 2020
• Actual Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 15, 2020): Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 15, 2020)

• Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo [ Time Frame: 12 weeks ]
• Proportion of patients maintaining abstinence from alcohol at 6 months in both groups [ Time Frame: 6 months ]
• Proportion of patients maintaining abstinence from alcohol at 12 months in both groups [ Time Frame: 12 months ]
• 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
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Liver Cirrhosis

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2020): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 31, 2022
• Actual Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT04391764
• Other Study ID Numbers: ILBS-Cirrhosis-28
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Institute of Liver and Biliary Sciences, India
• Original Responsible Party: Same as current
• Current Study Sponsor: Institute of Liver and Biliary Sciences, India
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institute of Liver and Biliary Sciences, India
• Verification Date: March 2023