Inpatient Single Dose Interventions for Alcohol Use Disorder

Ketamine

Brief 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.

Intervention / Treatment

  • Naltrexone 380 MG (DRUG)
    XR naltrexone to be given once prior to hospital discharge
  • Ketamine Hydrochloride (DRUG)
    IV ketamine infusion to be given once prior to hospital discharge
  • Enhanced linkage (BEHAVIORAL)
    Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up

Condition or Disease

  • Alcohol Use Disorder, Severe

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 44 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 19, 2021 ACTUAL
    Primary Completion: Jan 01, 2022 ACTUAL
    Completion Date: Feb 01, 2022 ACTUAL
    Study First Posted: Sep 24, 2020 ACTUAL
    Last Updated: Feb 02, 2022

    Sponsors / Collaborators

    Lead Sponsor: Denver Health and Hospital Authority
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • Participants will receive a single dose of extended-release, injectable naltrexone prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.

    • Participants will receive a single dose of intravenous ketamine (0.5mg/kg over 40 minutes) prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.

    • Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals)

    • Number of participants recruited per month during the enrollment period

    • Percentage of patients who presented to 1 week follow-up appointment

    Secondary Outcomes

    • Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.

    • Binary outcome: any all-cause ED visit ascertained by chart review

    • Obtained by urine EtG at outpatient follow-up

    • Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.

    More Details

    NCT Number: NCT04562779
    Other IDs: 20-2008
    Study URL: https://clinicaltrials.gov/study/NCT04562779
    Last updated: Sep 29, 2023