Inpatient Single Dose Interventions for Alcohol Use Disorder

Denver Health and Hospital Authority

Status and phase: Completed; Early Phase 1

Conditions: Alcohol Use Disorder, Severe

Treatments: Behavioral: Enhanced linkage; Drug: Naltrexone 380 MG; Drug: Ketamine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04562779

20-2008

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

XR Naltrexone

Experimental group

Description:

Participants will receive a single dose of extended-release, injectable naltrexone prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.

Treatment:

Behavioral: Enhanced linkage

Drug: Naltrexone 380 MG

IV Ketamine

Experimental group

Description:

Participants will receive a single dose of intravenous ketamine (0.5mg/kg over 40 minutes) prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.

Treatment:

Behavioral: Enhanced linkage

Drug: Ketamine Hydrochloride

Linkage

Active Comparator group

Description:

Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.

Treatment:

Behavioral: Enhanced linkage