Standard Versus High Dose ED-Initiated Buprenorphine Induction
ED-Initiated Standard Versus High Dose Buprenorphine Induction
Yale University
360 participants
Dec 6, 2024
INTERVENTIONAL
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 (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.
Eligibility
Inclusion Criteria7
- 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 Criteria14
- 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
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Interventions
All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06494904