Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.
Status:
Not yet recruiting
Trial end date:
2021-05-14
Target enrollment:
Participant gender:
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.