Emergency Department-Initiated Buprenorphine Validation Network Trial

Completed · Phase 2

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID

NCT04225598

Run by

Yale University

People needed

2000

Starts

2020-07-08

Expected to finish

2024-12-06

Last updated by the study team

2025-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 18 years or older
• Treated in the ED during study screening hours
• Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate to severe OUD
• Have a COWS score of > or equal to 4
• Have a urine toxicology test that is positive for opioids (opiates, oxycodone, buprenorphine). Patients with urines that are only positive for fentanyl will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD.
• Able to speak English sufficiently to understand the study the study procedures and provide written informed consent to participate in the study. (Exception may be made if sites with large population of Spanish speaking patients are accepted for participation in the study and study materials are translated into Spanish. Translated study materials will be reviewed and approved by the Institutional Review Board) IRB of record prior to use.)

You may not qualify if…

• Have urine toxicology test that is positive for methadone
• Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
• Have a medical or psychiatric condition that requires hospitalization
• Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
• Be actively suicidal or severely cognitively impaired precluding informed consent
• Present from an extended care facility (e.g., skilled nursing facility)
• Require continued prescription opioids for a pain condition
• Be a prisoner or in police custody at the time of index ED visit
• Be currently (anytime within the past 14 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction who are not receiving MOUD are eligible
• Be unable to provide reliable locator information including 2 contact numbers in addition to their own
• Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
• Have prior enrollment in the current study component
• Ancillary Component:
• Inclusion Criteria:
• Be 18 years or older
• Treated in the ED during study screening hours
• Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
• Have a COWS <8
• Have a urine toxicology test that is positive for opioids (opiates, oxycodone, or buprenorphine). Patients with urines that are only positive for fentanyl on the point of care test strip will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD.
• Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
• Exclusion Criteria:
• Have a urine toxicology test that is positive for methadone
• Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
• Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
• Be actively suicidal or severely cognitively impaired precluding informed consent

Where it is running

• 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
• Icahn School of Medicine — New York, New York, United States
• Columbia University Irving Medical Center- NY Presbyterian — 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

Full record on ClinicalTrials.gov

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