An observational study in Opioid Use Disorder, sponsored by Yale University. Recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Yale University · Observational
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 495 is above the median of 129 across 174 observational studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1
Exclusion Criteria:
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 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.
Time frame: 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
Time frame: Within 10 days after EMS encounter
Engagement in Treatment (30)
The proportion of patients participating in MOUD treatment
Time frame: Within 30 days after EMS encounter
Precipitated Withdrawal
The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine.
Time frame: Baseline
ED Visits and Hospitalizations
Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine
Time frame: 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
Time frame: Within 30 days after EMS-BUP encounter
Plan to share: 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.
No publications or documents are linked to this record.
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