In Hospital IM Naltrexone: A Pilot Study

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 8, 2021

Keywords

ClinConnect Summary

I. Hypotheses and Specific Aims: This proof of concept comparative effectiveness study seeks to pilot the administration of IM naltrexone among hospitalized adults with Diagnostic and Stastistical Manual-5 (DSM-5) diagnosis of alcohol use disorder at the University of Colorado Hospital and examine its acceptability and feasibility among patients and healthcare providers.

Study Aim 1: Test the feasibility and acceptability of recruiting, enrolling, and randomizing hospitalized patients, age 18 to 65 years old, with alcohol use disorder to treatment with in-hospital administration of IM nalt...

Gender

ALL

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