Clinical TrialAlcohol Use Disorder (AUD)PlaceboKetamineCompleted

Inpatient Single Dose Interventions for Alcohol Use Disorder

This interventional, randomised pilot feasibility study (n=44, age 18-65) aims to assess the potential of single-dose interventions (including ketamine) in reducing re-admissions for hospitalised patients with severe alcohol use disorder (AUD).

Target Enrollment
44 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

Randomised, parallel-group pilot assessing single-dose XR naltrexone (380 mg IM) or IV ketamine (0.5 mg/kg over 40 minutes) versus enhanced linkage alone among hospitalised patients with severe AUD to evaluate feasibility and 30-day readmission.

Feasibility outcomes include recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events; the study will estimate 30-day re-admission rates to inform a future comparative effectiveness trial.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

XR Naltrexone

experimental

Single pre-discharge injection of extended-release naltrexone plus enhanced linkage to follow-up addiction care.

Interventions

  • Placebo380 mg
    via IM• single dose• 1 doses total

    XR naltrexone 380 mg injection prior to discharge

  • Compound
    • single

    Enhanced linkage to care (in-hospital intake at outpatient addiction clinic plus contingency management)

IV Ketamine

experimental

Single pre-discharge IV ketamine infusion (0.5 mg/kg over 40 minutes) plus enhanced linkage to follow-up addiction care.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg infusion over 40 minutes prior to discharge

  • Compound
    • single

    Enhanced linkage to care (in-hospital intake at outpatient addiction clinic plus contingency management)

Linkage

active comparator

Enhanced linkage to follow-up addiction care without single-dose medication prior to discharge.

Interventions

  • Compound
    • single

    Enhanced linkage to care (in-hospital intake at outpatient addiction clinic plus contingency management)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

Denver Health Medical Center — Denver, Colorado, United States

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