Emergency Department-Initiated Buprenorphine Validation Network Trial
Key facts
- Who runs it
- Yale University
- Where
- Albuquerque, Atlanta, Baltimore, Camden, Charleston, Chicago, Dallas, Detroit, Durham, Lebanon, Martinsburg, Miami, Minneapolis, Nashville, New Haven, New York, Oakland, Philadelphia, Pittsburgh, Portland, Providence, Salt Lake City, San Leandro, Seattle, St Louis, Syracuse, Tampa, and Winston-Salem, United StatesSee the 35 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 2,000 people enrolled
- Started
- 8 Jul 2020
- Ended
- 6 Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CAM2038
- Buprenorphine Sublingual Product
- Record updated
- 10 January 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 36 criteriaShow less
Who can take part
- 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.)
- 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
Who cannot take part
- Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
- 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
- Have prior enrollment in the current study component; Ancillary Component:
- Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
- Be currently (anytime within the past 7 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction treatment but are not receiving MOUD are eligible
- Have prior enrollment in the current study
- Have a medical or psychiatric condition that requires hospitalization
- Require continued prescription opioids for a pain condition
- Require continued prescription opioids for a pain condition
- Have urine toxicology test that is positive for methadone
- Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Present from an extended care facility (e.g., skilled nursing facility)
- Be a prisoner or in police custody at the time of index ED visit
- 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 a urine toxicology test that is positive for methadone
- Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
- Be actively suicidal or severely cognitively impaired precluding informed consent
- Present from an extended care facility (e.g., skilled nursing facility)
- Be a prisoner or in police custody at the time of index ED visit
- 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 answer daily assessments until day 7)
Other criteria
- RCT Component:
Where in United States
- Presybterian Hospital, Albuquerque, NMAlbuquerque, United States
- University of New Mexico HospitalAlbuquerque, United States
- Grady Memorial HospitalAtlanta, United States
- Johns Hopkins HospitalBaltimore, United States
- Cooper University HospitalCamden, United States
- Medical University of South CarolinaCharleston, United States
- Northwestern Memorial HospitalChicago, United States
- University of Chicago MedicineChicago, United States
- Parkland Memorial HospitalDallas, United States
- Detroit Receiving HospitalDetroit, United States
- Henry Ford HospitalDetroit, United States
- Duke UniversityDurham, United States
- Dartmouth Hitchcock Medical CenterLebanon, United States
- West Virginia University - Berkeley Medical CenterMartinsburg, United States
- Jackson Memorial HospitalMiami, United States
- Hennepin County Medical CenterMinneapolis, United States
- Vanderbilt University Medical CenterNashville, United States
- Yale New Haven Health (Yale New Haven Hospital)New Haven, United States
- Bellevue HospitalNew York, United States
- Columbia University Irving Medical Center- NY PresbyterianNew York, United States
- Icahn School of MedicineNew York, United States
- Weill Cornell Medical CollegeNew York, United States
- Highland HospitalOakland, United States
- Pennsylvania Presbyterian Medical Center/Hospital of UPENNPhiladelphia, United States
- Temple University Hospital - Episcopal CampusPhiladelphia, United States
- UPMC-Mercy HospitalPittsburgh, United States
- Maine Medical CenterPortland, United States
- Rhode Island Hospital/The Miriam HospitalProvidence, United States
- University of Utah HospitalSalt Lake City, United States
- San Leandro HospitalSan Leandro, United States
- University of Washington Medical Center- Harborview/MontlakeSeattle, United States
- Barnes-Jewish HospitalSt Louis, United States
- Upstate Medical UniversitySyracuse, United States
- Tampa General HospitalTampa, United States
- Wake Forest School of MedicineWinston-Salem, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- XR-BUPTreatment being tested
Injectable buprenorphine
Treatment: CAM2038
- Standard SL-BUPExisting treatment, for comparison
Sublingual buprenorphine
Treatment: Buprenorphine Sublingual Product
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Publications
- Record updated
- 10 January 2025