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NCT04094584 · ClinicalTrials.gov registry record · Phase 4
Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
A Phase 4 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 4
- Development phase
- 179
- Enrollment target
NCT04094584: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
NCT04094584 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 179 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04094584, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 179 participants
- Enrollment target
Study Summary
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED. Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and there is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD. The rationale for including each component of the multimodal treatment is outlined below. Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent. ED patients with alcohol use disorders frequently suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs. Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar w
Primary Outcome
Percentage of enrolled participants who attend final study visit at the end of the intervention period
Interventions
- DRUG Vivitrol (Extended Release Naltrexone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2022-05-01 |
| Phase | Phase 4 |
Why NCT04094584 stopped before completion
NCT04094584 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Vivitrol (Extended Release Naltrexone) is the first listed.
NCT04094584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04094584 about?
NCT04094584 is a clinical study titled "Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder". This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED. Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency dep...
What is the current status of trial NCT04094584?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 179 participants. The study started on 2020-08-14. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT04094584?
The interventions under investigation include: Vivitrol (Extended Release Naltrexone) (DRUG).
Who is sponsoring clinical trial NCT04094584?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04094584's enrollment target sits among peer trials
179 476th of 2000 higher than 1,524 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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