NCT04225598

Emergency Department-Initiated Buprenorphine Validation Network Trial

Completed Phase 2 Last updated 10 January 2025

What this trial tests

Phase 2 trial testing CAM2038 in Opioid-use Disorder in 2,000 participants. Completed in 6 December 2024.

Timeline

8 July 2020

Primary endpoint
6 December 2024

6 December 2024

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,000
Start date	8 July 2020
Primary completion	6 December 2024
Estimated completion	6 December 2024
Sites	35 locations across United States

Drugs / interventions tested

• CAM2038 — full drug profile →
• Buprenorphine Sublingual Product — full drug profile →

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Yale University

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incidence of Precipitated Withdrawal During a Multisite Emergency Department-Initiated Buprenorphine Clinical Trial in the Era of Fentanyl.
   D'Onofrio G, Hawk KF, Perrone J, Walsh SL, et al · · 2023 · cited 49× · PMID 36995717 · DOI 10.1001/jamanetworkopen.2023.6108
2. Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal.
   D'Onofrio G, Herring AA, Perrone J, Hawk K, et al · · 2024 · cited 17× · PMID 38976265 · DOI 10.1001/jamanetworkopen.2024.20702
3. Emergency department-initiated buprenorphine protocols: A national evaluation.
   Guo CZ, D'Onofrio G, Fiellin DA, Edelman EJ, et al · · 2021 · cited 13× · PMID 34877567 · DOI 10.1002/emp2.12606
4. URINE TOXICOLOGY PROFILES OF EMERGENCY DEPARTMENT PATIENTS WITH UNTREATED OPIOID USE DISORDER: A MULTI-SITE VIEW.
   Cowan E, Perrone J, Dziura J, Edelman EJ, et al · · 2023 · cited 4× · PMID 37716904 · DOI 10.1016/j.jemermed.2023.06.007
5. Emergency Department-Initiated Buprenorphine for Opioid Use Disorder: A Randomized Clinical Trial.
   D'Onofrio G, Herring AA, Hawk KF, Perrone J, et al · · 2026 · cited 1× · PMID 41670966 · DOI 10.1001/jama.2025.27019