EMS-Initiated Buprenorphine
EMS BUP
Emergency Medical Services (EMS)-Initiated Buprenorphine
2 other identifiers
observational
495
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
May 28, 2026
May 1, 2026
2.8 years
March 4, 2026
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Engagement in Treatment (30)
Within 30 days after EMS encounter
Precipitated Withdrawal
Baseline
ED Visits and Hospitalizations
Within 30 days after EMS encounter
Adverse Events
Within 30 days after EMS-BUP encounter
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients who lack decision making capacity
- Patients who are in police or protective custody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Emmes Company, LLCcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
- Yale Universitylead
- National Drug Abuse Treatment Clinical Trials Networkcollaborator
Study Sites (3)
Alameda Health System
Oakland, California, 94602, United States
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail D'Onofrio, MD, MS
Yale University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 16, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.