Emergency Department-Initiated Buprenorphine Validation Network Trial

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.

Timeline

Start

2020-07-08

Primary completion

2024-12-06

Completion

2024-12-06

Publications

• D'Onofrio G, Herring AA, Hawk KF, Perrone J, Cowan E, McCormack RP, Dziura J, Matthews AG, Pantalon MV, Owens P, Martel S, Coupet E Jr, Lofwall MR, Walsh SL, Edelman EJ, Carpenter JE, Strout TD, Baumann MR, Anderson E, Barrett TW, Dorey A, Taillac P, Cochran G, Crandall CS, Wilson J, Manteuffel J, Cole JB, Whiteside LK, Jones C, Samuels E, Huntley K, Fiellin DA; ED INNOVATION Investigators. Emergency Department-Initiated Buprenorphine for Opioid Use Disorder: A Randomized Clinical Trial. JAMA. 2026 Mar 17;335(11):948-960. doi: 10.1001/jama.2025.27019.
• D'Onofrio G, Herring AA, Perrone J, Hawk K, Samuels EA, Cowan E, Anderson E, McCormack R, Huntley K, Owens P, Martel S, Schactman M, Lofwall MR, Walsh SL, Dziura J, Fiellin DA. Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal. JAMA Netw Open. 2024 Jul 1;7(7):e2420702. doi: 10.1001/jamanetworkopen.2024.20702.
• Snavely AC, Paradee BE, Ashburn NP, Allen BR, Christenson R, O'Neill JC, Nowak R, Wilkerson RG, Mumma BE, Madsen T, Stopyra JP, Mahler SA. Derivation and validation of a high sensitivity troponin-T HEART pathway. Am Heart J. 2023 Feb;256:148-157. doi: 10.1016/j.ahj.2022.11.012. Epub 2022 Nov 16.

Drugs

Indications