Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04562779 · ClinicalTrials.gov registry record · Early Phase 1
Inpatient Single Dose Interventions for Alcohol Use Disorder
A Early Phase 1 study, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 44
- Enrollment target
NCT04562779 is a Early Phase 1 study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 44 participants.
The verdict
NCT04562779, a Early Phase 1 study, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 44 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ketamine Hydrochloride
- DRUG Naltrexone 380 MG
- BEHAVIORAL Enhanced linkage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2022-02-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04562779
The ClinicalTrials.gov registry entry for NCT04562779 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ketamine Hydrochloride is the first listed.
NCT04562779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04562779 about?
NCT04562779 is a clinical study titled "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...
What is the current status of trial NCT04562779?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 44 participants. The study started on 2021-01-19. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT04562779?
The interventions under investigation include: Ketamine Hydrochloride (DRUG), Naltrexone 380 MG (DRUG), Enhanced linkage (BEHAVIORAL).
Who is sponsoring clinical trial NCT04562779?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.