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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
XR naltrexone to be given once prior to hospital discharge
IV ketamine infusion to be given once prior to hospital discharge
Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up
Denver Health Medical Center
Denver, Colorado, United States
Rate (%) of 30-day Hospital Re-admission
Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals). Note that it is not dependent on study completion, so it is analyzed by intent to treat.
Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.
Feasibility - Recruitment Rate (# Per Month)
Number of participants recruited per month during the enrollment period
Time frame: The enrollment period is 12 months
Feasibility - Follow-up Rate (%)
Percentage of patients who presented to follow-up appointment within 14 days
Time frame: 14 days
Rate (%) of 30-day Emergency Department Visit
Binary outcome: any all-cause ED visit ascertained by chart review
Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.
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