Emergency Department-Initiated Buprenorphine Validation Network Trial
Public ClinicalTrials.gov record NCT04225598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04225598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2020
- Primary completion
- Dec 5, 2024
- Completion
- Dec 5, 2024
- Last update posted
- Jan 9, 2025
2020 – 2024
United States locations
- U.S. sites
- 35
- U.S. states
- 23
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highland Hospital | Oakland | California | 94602 | — |
| San Leandro Hospital | San Leandro | California | 94578 | — |
| Yale New Haven Health (Yale New Haven Hospital) | New Haven | Connecticut | 06510 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Presybterian Hospital, Albuquerque, NM | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | — |
| Bellevue Hospital | New York | New York | 10016 | — |
| Icahn School of Medicine | New York | New York | 10029 | — |
| Columbia University Irving Medical Center- NY Presbyterian | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Upstate Medical University | Syracuse | New York | 13210 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27101 | — |
| Pennsylvania Presbyterian Medical Center/Hospital of UPENN | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital - Episcopal Campus | Philadelphia | Pennsylvania | 19125 | — |
| UPMC Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | — |
| Rhode Island Hospital/The Miriam Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| University of Washington Medical Center- Harborview/Montlake | Seattle | Washington | 98195 | — |
| West Virginia University - Berkeley Medical Center | Martinsburg | West Virginia | 25401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04225598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 9, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04225598 live on ClinicalTrials.gov.