Standard Versus High Dose ED-Initiated Buprenorphine Induction

Recruiting now · Phase 3

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT06494904

Run by

Yale University

People needed

360

Starts

2024-12-06

Expected to finish

2028-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Have a respiratory rate <8 or oxygen saturation <93%
• Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

Where it is running

• Highland Hospital — Oakland, California, United States (enrolling)
• San Leandro Hospital — San Leandro, California, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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