Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT07475728

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Study ID

NCT07475728

Start date

May 21, 2026

Status verified date

Aug, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

495 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Individuals 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 ]
  • Primary Outcome Measure for the Single Arm Prospective Trial [ Time Frame: Within 10 days after EMS encounter ]

Central Contacts and Locations

Central contacts

Gail D'Onofrio, MD, MS

12037857059gail.donofrio@yale.edu

Gerard Carroll, MD

Carroll-Gerard@CooperHealth.edu

Locations

Alameda Health System

Recruiting

Oakland, California, United States, 94602

Contacts

Andrew Herring, MD

510-437-4800aherring@alamedahealthsystem.org

Hennepin Healthcare

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Nicholas Simpson, MD

612-873-3000Nick.Simpson@hcmed.org

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Gerard Carroll, MD

Carroll-Gerard@CooperHealth.edu

Jessica Heil

heil-jessica1@CooperHealth.edu

More Information

Sponsor

Yale University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Emergency Medical Services
  • Buprenorphine
  • Substance use disorder treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-27.