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NCT04225598 · ClinicalTrials.gov registry record · Phase 2
Emergency Department-Initiated Buprenorphine Validation Network Trial
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,000
- Enrollment target
NCT04225598 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 2,000 participants.
The verdict
NCT04225598, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,000 participants
- Enrollment target
Study Summary
This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores \< 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.
Interventions
- DRUG Buprenorphine Sublingual Product
- DRUG CAM2038
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2024-12-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04225598
The ClinicalTrials.gov registry entry for NCT04225598 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine Sublingual Product is the first listed.
NCT04225598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04225598 about?
NCT04225598 is a clinical study titled "Emergency Department-Initiated Buprenorphine Validation Network Trial". This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medic...
What is the current status of trial NCT04225598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,000 participants. The study started on 2020-07-08. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT04225598?
The interventions under investigation include: Buprenorphine Sublingual Product (DRUG), CAM2038 (DRUG).
Who is sponsoring clinical trial NCT04225598?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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