Status:
RECRUITING
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 (SD...
Detailed Description
This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MO...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06494904
Start Date
December 6 2024
End Date
December 1 2028
Last Update
April 25 2025
Active Locations (5)
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1
Highland Hospital
Oakland, California, United States, 94602
2
San Leandro Hospital
San Leandro, California, United States, 94578
3
Maine Medical Center
Portland, Maine, United States, 04102
4
Cooper University Hospital
Camden, New Jersey, United States, 08103