In Hospital IM Naltrexone: A Pilot Study (IM-NTX)
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
Participants will include hospitalized adults, aged 18 to 65 years old, who receive care from the ACS during their hospitalization and who meet DSM - 5 criteria for alcohol use disorder.
Exclusion Criteria:
Naltrexone is contraindicated in acute hepatitis or liver failure and its use in patients with active liver disease must be carefully considered in light of the potential for hepatotoxic effects.23 It is also contraindicated in patients taking opioids for pain due to its antagonism at the opioid receptor.23 The investigators will exclude people who meet the following criteria:
- Liver function test (AST/ALT) more than five times the upper limit of normal
- Decompensated liver failure defined as use of lactulose for prevention of hepatic encephalopathy, ascites, use of spironolactone and/or lasix for ascites, presence of hepatic encephalopathy, International Normalized Ratio (INR) >2, or thrombocytopenia in the setting of known liver disease
- Renal failure, defined as a glomerular filtration rate of <30 ml/min
- On opioids for acute or chronic pain at time of study enrollment
- Pregnancy, IM naltrexone is not FDA approved in pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Oral naltrexone
injectable naltrexone
patients will receive a 30 day supply of oral naltrexone 50 mg daily at hospital discharge. This medication was FDA approved in 1984 for the treatment of alcohol use disorder
patient will receive 360 mg injection of naltrexone prior to hospital discharge