NCT06494904 Standard Versus High Dose ED-Initiated Buprenorphine Induction
| NCT ID | NCT06494904 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yale University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2024-12-06 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
Inclusion Criteria: All patients enrolled into the study must: 1. Be 18-65 years of age. 2. Be treated in the ED during study screening hours. 3. Meet DSM-5 diagnostic criteria for moderate to severe OUD. 4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment). 5. Have a urine toxicology test that is positive for opioids. 6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: All patients enrolled into the study must not: 1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit. 2. Have a known hypersensitivity reaction to buprenorphine/naloxone 3. Be actively suicidal or severely cognitively impaired precluding informed consent. 4. Require ongoing prescription for opioid analgesics. 5. Have a physical exam or reported history consistent with severe liver failure 6. Have a positive urine test for methadone and reported use in the past 72 hours 7. Be a prisoner or in police custody at the time of index ED visit. 8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments) 9. Have prior enrollment in the current study. 10. Receiving MOUD treatment within the past 7 days. 11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit 12. Have a respiratory rate \<8 or oxygen saturation \<93% 13. 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
Contact & Investigator
Gail D'Onofrio, MD, MS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06494904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06494904 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT06494904 currently recruiting?
Yes, NCT06494904 is actively recruiting participants. Contact the research team at gail.donofrio@yale.edu for enrollment information.
Where is the NCT06494904 trial being conducted?
This trial is being conducted at Oakland, United States, San Leandro, United States, Portland, United States, Camden, United States and 1 additional location.
Who is sponsoring the NCT06494904 clinical trial?
NCT06494904 is sponsored by Yale University. The principal investigator is Gail D'Onofrio, MD, MS at Yale University. The trial plans to enroll 360 participants.