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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: Completed Phase 2 study, sponsored by Yale University.
NCT04225598 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 2,000 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1404% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (O
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 |
What the finished NCT04225598 record still lists
NCT04225598 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1404% higher).
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine Sublingual Product is the first listed.
NCT04225598 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04225598's enrollment target sits among peer trials
2,000 8th of 2000 higher than 1,992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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