Skip to main content
OpenTrials
Completed

NCT Number: NCT04562779

Inpatient Single Dose Interventions for Alcohol Use Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Use Disorder, Severe Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Rate (%) of 30-day Hospital Re-admission

    Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.

    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.

  2. Feasibility - Recruitment Rate (# Per Month)

    Time frame: The enrollment period is 12 months

    Number of participants recruited per month during the enrollment period

  3. Feasibility - Follow-up Rate (%)

    Time frame: 14 days

    Percentage of patients who presented to follow-up appointment within 14 days

Secondary outcomes

  1. Rate (%) of 30-day Emergency Department Visit

    Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.

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

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2020
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.