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High Dose Buprenorphine Induction in the Emergency Department for Opioid Use Disorder

This study is looking at whether a higher dose of buprenorphine (BUP) given in the emergency department (ED) is safe and helps more people with Opioid Use Disorder (OUD) get into addiction treatment. Researchers are comparing a standard dose of BUP (12mg) with a higher dose (32mg). They want to see if the higher dose helps more people connect with comprehensive addiction services within 7 days after leaving the ED. To join, you must be at least 18 years old, have moderate to severe OUD, show signs of opioid withdrawal, and test positive for fentanyl. The study is currently unclear on its recruitment status, but plans to enroll 140 participants.

Study design
This is an interventional study comparing two groups: one receiving a standard buprenorphine dose and another receiving a high buprenorphine dose. It will enroll 140 participants.
What's involved
You would receive buprenorphine in two doses within 30-60 minutes and be monitored for 4 hours after the last dose. You would also be assessed at 7 days post-ED visit.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 7 days after their emergency department visit.

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NCT05589181

High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~140 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:High Dose BuprenorphineStandard Buprenorphine Dose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
Measured over 7 days post-ED visit

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Ethan Cowan, MD, MS · PRINCIPAL_INVESTIGATOR · The Rutgers Addiction Research Center

Who to contact

Ethan Cowan, MD, MS
[email protected]
(917) 447-4964
Email the study team

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Eligibility criteria

Inclusion

Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
Treated in the ED during screening hours
Meet DSM-5 diagnostic criteria for moderate to severe OUD
Clinical Opioid Withdrawal Score (COWS) score ≥ 8
Urine toxicology positive for fentanyl
Able to speak English or Spanish sufficiently to understand study procedures

Exclusion

UDS positive for methadone.
Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing
Have an unstable medical or psychiatric condition including suicidality requiring hospitalization
Require ongoing opioids for pain management
Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible
Be a prisoner or in custody at the time of the index visit
Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.
Unable to provide one additional point of contact other than themselves
Unwilling to follow study procedures
Have prior enrollment in the current study
Have a known allergy or hypersensitivity to BUP
Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA)
Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration
Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study

What this trial measures

  • The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction7 days post-ED visit

    The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program.