NCT07475728

EMS-Initiated Buprenorphine

Emergency Medical Services (EMS)-Initiated Buprenorphine

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 495 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Evaluating the EMS clinical protocol details and subsequent research procedures will be accomplished by enrolling approximately five EMS-initiated BUP encounters per site. Subsequently, a pragmatic field study will engage approximately thirty successful BUP initiations to assess the feasibility, acceptability, and safety of the EMS clinical protocol and follow up procedures. Investigators will also enroll a cohort of up to thirty patients per site who are eligible for BUP but refuse for informative purposes only, to understand reasons for refusal. Qualitative data on the refusal cohort will be analyzed separately. The outcomes of the pragmatic studies will inform revisions to the EMS clinical protocol. A single-arm prospective trial of approximately 100 patients per site will subsequently be conducted to collect preliminary data on the effectiveness of EMS-initiated BUP on engagement in MOUD treatment within 10 and 30 days after the EMS-initiated BUP encounter.

Conditions

• Opioid Use Disorder

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2029-05-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

3 sites across 1 country: United States