Who is eligible for clinical trial NCT06494904?

Participants must meet protocol criteria for Opioid Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06494904 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-27

Standard Versus High Dose ED-Initiated Buprenorphine Induction (NCT06494904)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).

Location: Highland Hospital — Oakland, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

All patients enrolled into the study must:
Be 18-65 years of age.
Be treated in the ED during study screening hours.
Meet DSM-5 diagnostic criteria for moderate to severe OUD.
Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
Have a urine toxicology test that is positive for opioids.
Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Usually NOT eligible if any of the following apply:

Exclusion Criteria: All patients enrolled into the study must not:
Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
Have a known hypersensitivity reaction to buprenorphine/naloxone
Be actively suicidal or severely cognitively impaired precluding informed consent.
Require ongoing prescription for opioid analgesics.
Have a physical exam or reported history consistent with severe liver failure
Have a positive urine test for methadone and reported use in the past 72 hours
Be a prisoner or in police custody at the time of index ED visit.
Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
Have prior enrollment in the current study.
Receiving MOUD treatment within the past 7 days.
Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

Highland Hospital — Oakland, California
San Leandro Hospital — San Leandro, California
Maine Medical Center — Portland, Maine
Cooper University Hospital — Camden, New Jersey
University of Utah Hospital — Salt Lake City, Utah

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗