Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.

20-2008

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.

2021-01-19

2022-01-01

2022-02-01

Completed

Early phase I

44

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

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2024-05-02