EMS-Initiated Buprenorphine (EMS BUP)

Emergency Medical Services (EMS)-Initiated Buprenorphine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 495

Contacts and Locations

• Study Contact: Name: Gail D'Onofrio, MD, MS; Phone Number: 12037857059; Email: gail.donofrio@yale.edu
• Study Contact Backup: Name: Gerard Carroll, MD; Email: Carroll-Gerard@CooperHealth.edu

Study Locations

• United States
  • California
    • Oakland, California, United States, 94602
      • Alameda Health System
      • Contact: Andrew Herring, MD; Phone Number: (510) 437-4800; Email: aherring@alamedahealthsystem.org
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare
      • Contact: Nicholas Simpson, MD; Phone Number: (612) 873-3000; Email: Nick.Simpson@hcmed.org
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
      • Contact: Gerard Carroll, MD; Email: Carroll-Gerard@CooperHealth.edu
      • Contact: Jessica Heil; Email: heil-jessica1@CooperHealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals in the prehospital setting with OUD 1) presenting with overdose requiring naloxone reversal or 2) in acute opioid abstinence withdrawal offered an EMS clinical protocol across approximately three ED-EMS systems.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure for Pragmatic Field Study	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.	Baseline
Primary Outcome Measure for the Single Arm Prospective Trial	The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed	Within 10 days after EMS encounter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in Treatment (30)	The proportion of patients participating in MOUD treatment	Within 30 days after EMS encounter
Precipitated Withdrawal	The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine.	Baseline
ED Visits and Hospitalizations	Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine	Within 30 days after EMS encounter
Adverse Events	The number of adverse events per participant after EMS-BUP initiation among all those who accepted EMS-BUP	Within 30 days after EMS-BUP encounter

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; National Drug Abuse Treatment Clinical Trials Network
• Investigators: Principal Investigator: Gail D'Onofrio, MD, MS, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Buprenorphine; Substance use disorder treatment
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000041916; 3UG1DA015831-24S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In line with the National Institutes of Health Helping to End Addiction Long-term (NIH HEAL) Initiative Public Access and Data Sharing Policy, publications and underlying primary data will be made available to the public.
• IPD Sharing Time Frame: Data will be made available after 1) The primary outcome paper has been accepted for publication, or 2) the data is locked for more than 18 months, whichever comes first.
• IPD Sharing Access Criteria: De-identified scientific data generated from this study will be made available to the public in the NIDA data repository, per NIDA CTN policy and the Data Management and Sharing Plan for the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No