Clinical trialNCT04225598CompletedPhase 2Interventional

Emergency Department-Initiated Buprenorphine Validation Network Trial

SponsorYale UniversityEnrollment2,000Opioid-use Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

David Fiellin, MD
Yale School of Medicine, Department of Internal Medicine
Principal Investigator
clinicaltrials.gov ↗
Gail D'Onofrio, MD, MS
Yale School of Medicine, Department of Emergency Medicine
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

35 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Highland Hospital
Oakland, California, United States
San Leandro Hospital
San Leandro, California, United States
Yale New Haven Health (yale New Haven Hospital)
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Presybterian Hospital, Albuquerque, Nm
Albuquerque, New Mexico, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Bellevue Hospital
New York, New York, United States
Columbia University Irving Medical Center- Ny Presbyterian
New York, New York, United States
Icahn School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Upstate Medical University
Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Pennsylvania Presbyterian Medical Center/hospital of Upenn
Philadelphia, Pennsylvania, United States
Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania, United States
Upmc Mercy Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital/the Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Parkland Memorial Hospital
Dallas, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Washington Medical Center- Harborview/montlake
Seattle, Washington, United States
West Virginia University - Berkeley Medical Center
Martinsburg, West Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Buprenorphine →CAM2038

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Jul 2020
Primary completion: 6 Dec 2024
Completion: 6 Dec 2024
Last update posted: 10 Jan 2025
Registered enrollment: 2,000
Registry id: NCT04225598

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.