CTN-0099: Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION)

Gail D’Onofrio, MD, MS
Lead Investigator

Yale University School of Medicine
Department of Emergency Medicine

David Fiellin, MD
Lead Investigator

Yale University School of Medicine

Emergency Department (ED) initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to 7 days. This study will recruit, train, and provide resources to up to 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD.

Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus 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 use of XR-BUP will be assessed 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. Electronic health record (EHR) phenotypes of opioid-related illnesses will be developed and validated to characterize ED visits, better identify patients eligible for study inclusion, and facilitate future capacity for predictive analytics.

Funded by the NIH HEAL InitiativeSM.

    Node Involvement

    Lead Node(s):

  • New England Consortium Node

  • All Participating Nodes:

  • Appalachian Node
  • New England Consortium Node
  • Northstar Node
  • Pacific Northwest Node