Not Yet RecruitingNot Applicable

EMS-Initiated Buprenorphine

United States495 participantsStarted 2026-03

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * Treated by the EMS-Initiated buprenorphine clinical protocol which includes: Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1 * Willing to follow study procedures. * Able to speak English sufficiently to understand study procedures, and to provide verbal and electronic/written consent. Exclusion Criteria: * Patients who lack decision making capacity * Patients who are in police or protective custody

What they're measuring

Primary Outcome Measure for Pragmatic Field Study

Timeframe: Baseline

Primary Outcome Measure for the Single Arm Prospective Trial

Timeframe: Within 10 days after EMS encounter

Trial details

NCT IDNCT07475728

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-03

Contact for this trial

Gail D'Onofrio, MD, MS

12037857059 gail.donofrio@yale.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials