Standard Versus High Dose ED-Initiated Buprenorphine Induction (NCT06494904)
ED-Initiated Standard Versus High Dose Buprenorphine Induction
🩺 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
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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).
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
📞 Contact the Study Coordinator
Phone: (203) 785-7059
Email: gail.donofrio@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Opioid Use Disorder
- Adversity, Brain and Opioid Use Study — Ann Arbor, Michigan
- Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder — Atlantic City, New Jersey
- Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD — Charleston, South Carolina
- Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis — Ann Arbor, Michigan
- Focused Ultrasound for the Complex Patient — Washington D.C., District of Columbia
Explore by condition: All Opioid Use Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.