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.
Phase:
Phase 2
Details
Lead Sponsor:
Yale University
Collaborators:
Alameda Health System Harvard Medical School Harvard Medical School (HMS and HSDM) Icahn School of Medicine at Mount Sinai National Drug Abuse Treatment Clinical Trials Network NYU Langone Health The Emmes Company, LLC University of Pennsylvania Weill Medical College of Cornell University