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NCT Number: NCT07475728

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Alameda Health System, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary Outcome Measure for Pragmatic Field Study

    Time frame: 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.

  2. Primary Outcome Measure for the Single Arm Prospective Trial

    Time frame: 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

Secondary outcomes

  1. Engagement in Treatment (30)

    Time frame: Within 30 days after EMS encounter

    The proportion of patients participating in MOUD treatment

  2. Precipitated Withdrawal

    Time frame: Baseline

    The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine.

  3. ED Visits and Hospitalizations

    Time frame: Within 30 days after EMS encounter

    Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine

  4. Adverse Events

    Time frame: Within 30 days after EMS-BUP encounter

    The number of adverse events per participant after EMS-BUP initiation among all those who accepted EMS-BUP

Study contacts

Contact information is provided by the study sponsor or research team.

Gail D'Onofrio, MD, MS

CONTACT

[email protected]

12037857059

Gerard Carroll, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Drug Abuse Treatment Clinical Trials Network
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC

Registry information

Official study title

Emergency Medical Services (EMS)-Initiated Buprenorphine

Acronym: EMS BUP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 16, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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