Opioid Use DisorderEMS BUPNCT07475728
EMS-Initiated Buprenorphine
An observational study of Opioid Use Disorder, run by Yale University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Use Disorder
- How many people
- 495 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 May 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who lack decision making capacity
- Patients who are in police or protective custody
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gerard Carroll, MD contact
United States3 sites, 3 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Gerard Carroll, MD, Carroll-Gerard@CooperHealth.edu
Jessica Heil, heil-jessica1@CooperHealth.edu
- Recruiting
Hennepin Healthcare
Minneapolis, Minnesota, 55415
Nicholas Simpson, MD, 612-873-3000, Nick.Simpson@hcmed.org
- Recruiting
Alameda Health System
Oakland, California, 94602
Andrew Herring, MD, 510-437-4800, aherring@alamedahealthsystem.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Keywords
- Emergency Medical Services, Buprenorphine, Substance use disorder treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Within 10 days after EMS encounter
Secondary outcomes (4)
Engagement in Treatment (30)
The proportion of patients participating in MOUD treatment
Measured: Within 30 days after EMS encounter
Precipitated Withdrawal
The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine.
Measured: Baseline
ED Visits and Hospitalizations
Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine
Measured: 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
Measured: Within 30 days after EMS-BUP encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start21 May 2026
- Primary completionMar 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Gail D'Onofrio, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475728
- Sponsor's protocol ID
- 2000041916
- Other IDs
- 3UG1DA015831-24S1
- Acronym
- EMS BUP
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Medical Services (EMS)-Initiated Buprenorphine
- ClinicalTrials.gov ID
- NCT07475728
- Acronym / sponsor ID
- EMS BUP / 2000041916
- Conditions
- Opioid Use Disorder
- Keywords
- Emergency Medical Services, Buprenorphine, Substance use disorder treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA)
- Study start
- 21 May 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who lack decision making capacity
- Patients who are in police or protective custody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
4 secondary outcomes
Engagement in Treatment (30)
Time frame: Within 30 days after EMS encounter
Precipitated Withdrawal
Time frame: Baseline
ED Visits and Hospitalizations
Time frame: Within 30 days after EMS encounter
Adverse Events
Time frame: Within 30 days after EMS-BUP encounter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerard Carroll, MD contact
Gail D'Onofrio, MD, MS principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gail D'Onofrio, MD, MS (12037857059, gail.donofrio@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure for Pragmatic Field Study (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.