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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: Completed Early Phase 1 study, sponsored by Denver Health and Hospital Authority.
NCT04562779 is a Early Phase 1 study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 44 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT04562779 record still lists
NCT04562779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketamine Hydrochloride is the first listed.
NCT04562779 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04562779's enrollment target sits among peer trials
44 589th of 2000 higher than 1,402 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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