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Early Phase 1 N=44 Randomized Treatment

Inpatient Single Dose Interventions for Alcohol Use Disorder

Alcohol Use Disorder, Severe

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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