Early Phase 1
N=44
Inpatient Single Dose Interventions for Alcohol Use Disorder
Alcohol Use Disorder, Severe
Bottom Line
View on ClinicalTrials.gov: NCT04562779 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Rate (%) of 30-day Hospital Re-admission — 3; 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Naltrexone 380 MG (Drug); Ketamine Hydrochloride (Drug); Enhanced linkage (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate (%) of 30-day Hospital Re-admission |
3; 2; 7 | — |
| PRIMARY Feasibility - Recruitment Rate (# Per Month) |
3.7 | — |
| PRIMARY Feasibility - Follow-up Rate (%) |
7; 8; 7 | — |
| SECONDARY Rate (%) of 30-day Emergency Department Visit |
8; 7; 12 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04562779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.