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Opioid Partial Agonist

High Dose Buprenorphine for Opioid Use Disorder

Phase 3
Recruiting
Led By Ethan Cowan, MD, MS
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 240 minutes
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests if a higher buprenorphine dose is safe & can increase engagement in addiction services.

Who is the study for?
This trial is for adults in the emergency department with moderate to severe opioid use disorder, showing withdrawal symptoms and a positive test for fentanyl. They must understand the study and agree to participate. Excluded are those with legal issues, no additional contact point, unwillingness to follow procedures, recent naloxone use, pain management opioids need, methadone presence in tests, pregnancy, unstable conditions requiring hospitalization or current/formal addiction treatment.
What is being tested?
The trial compares two doses of Buprenorphine: a standard dose (12mg) versus a high dose (32mg), which can be reduced to 24mg if necessary. The goal is to see if higher doses are safe and increase engagement in addiction treatment after one week. It includes an initial head-to-head comparison followed by a small pilot randomized double-blinded trial.
What are the potential side effects?
Potential side effects of Buprenorphine may include nausea, vomiting, dizziness, constipation or headaches. High doses could potentially amplify these effects but this will be closely monitored during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 240 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 240 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
Secondary study objectives
Opioids
Change in number of times opioids used (Trial 2)
Daily assessment of opioid use (Trial 1)
+8 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Buprenorphine High DoseExperimental Treatment1 Intervention
The experimental arm tests the safety and tolerability of 32mg of BUP split as 16mg at time=0 and 16mg at time=30-60 min as an induction dose.
Group II: Buprenorphine Standard DoseActive Control1 Intervention
The standard arm will receive an induction dose of 12mg of buprenorphine (BUP) split as 8mg at time=0 and 4mg at time=30-60 min.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,681 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,408 Total Patients Enrolled
Ethan Cowan, MD, MSPrincipal InvestigatorIcahn School of Medicine

Media Library

Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05589181 — Phase 3
Opioid Use Disorder Research Study Groups: Buprenorphine Standard Dose, Buprenorphine High Dose
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT05589181 — Phase 3
Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05589181 — Phase 3
~45 spots leftby Sep 2025
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