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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 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 179 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04094584
The ClinicalTrials.gov registry entry for NCT04094584 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vivitrol (Extended Release Naltrexone) is the first listed.
NCT04094584 reports 0 study locations.
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.
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