Inpatient Single Dose Interventions for Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to:

1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study.

2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Ketamine; Naltrexone

Criteria

Inclusion Criteria:

• Age 18-65

• 1+ alcohol-related* admission(s) or emergency department visit(s) in past 12 mo.

• Has insurance (public or private)

• Seen by inpatient addiction consult service

Exclusion Criteria:

• Known or suspected active COVID-19 infection

• Hepatic: AST/ALT >5x upper-limit of normal, decompensated liver failure

• Renal: Glomerular filtration rate <30ml/min

• Cardiovascular: History of acute coronary syndrome, cerebrovascular event, hypertensive crisis, known cardiomyopathy

• Known elevated intracranial pressure

• Thrombocytopenia (<50/microliter)

• Active moderate/severe withdrawal (based on hospital withdrawal protocol)

• Active delirium (alcohol-related or otherwise)

• Already enrolled in study

• XR naltrexone or IV ketamine in last 30 days

• Known intolerance to naltrexone or ketamine

• Other active severe substance use disorder (tobacco, cannabis excluded)

• Pregnant or breast-feeding, or planning.

• Opioids: chronic, recent (<24h), or anticipated

• Unstable psychiatric illness (active psychosis, active suicidality)

• Moving from region within 30-days of discharge

• Discharge to acute/residential treatment

• Involuntary hold