Emergency Medical Services (EMS)-Initiated Buprenorphine (EMS BUP)

NCT07475728 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Yale University
Status	NOT_YET_RECRUITING
Enrolment	495
Start date	2026-03
Completion	2029-05

Conditions

• Opioid Use Disorder

Primary outcomes

• Primary Outcome Measure for Pragmatic Field Study — Baseline
  Feasibility and acceptability will be measured by the proportion of patients who accept EMS-initiated BUP among all patients who are offered the EMS-initiated BUP clinical protocol.
• Primary Outcome Measure for the Single Arm Prospective Trial — Within 10 days after EMS encounter
  The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed

Countries

United States