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CompletedEarly Phase 1Results posted

Inpatient Single Dose Interventions for Alcohol Use Disorder

NCT04562779 · Denver Health and Hospital Authority

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
44
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Rate (%) of 30-day Hospital Re-admission

    Measured over Within 30 days of index hospital discharge. The enrollment period is 12 months.

  • Feasibility - Recruitment Rate (# Per Month)

    Measured over The enrollment period is 12 months

  • Feasibility - Follow-up Rate (%)

    Measured over 14 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Denver Health Medical CenterDenverColoradoUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04562779 on ClinicalTrials.gov →

Last updated in the registry 2024-05-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in