EMS-Initiated Buprenorphine
Part of paid clinical trials in Oakland, California.
- Sponsor
- Yale University
- Study ID
- NCT07475728
- Status
- Not Yet Recruiting
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Conditions
- Opioid Use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
This is a multisite EMS study that will first conduct a sequence of pragmatic, prehospital field studies to provide preliminary feasibility, acceptability, and safety data for refinement and enhancement of a subsequent single-arm prospective trial that will provide preliminary effectiveness data, from which to build a larger randomized control trail (RCT) trial.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- May 2026
- Primary completion
- Mar 31, 2029
- Completion
- May 31, 2029
Study Design
- Enrollment
- 495 participants (estimated)
Arms
- Arm: ParticipantsIndividuals with opioid use disorder (OUD) who encounter Emergency Medical Services (EMS) in the prehospital setting under one of two circumstances: (1) They have experienced an overdose requiring naloxone reversal or (2) They are in acute opioid abstinence withdrawal and are offered an EMS-initiated BUP clinical protocol.
Primary Outcome Measure
Primary Outcome Measure for Pragmatic Field Study [ Time Frame: Baseline ]
Central Contacts
- Gail D'Onofrio, MD, MS12037857059
- Gerard Carroll, MD
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Alameda Health System | Oakland | California | 94602 | |
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | |
| Cooper University Hospital | Camden | New Jersey | 08103 | Gerard Carroll, MD Jessica Heil |
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