NCT05589181 High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
| NCT ID | NCT05589181 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-04-06 |
| Primary Completion | 2026-09-01 |
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 140 participants in total. It began in 2023-04-06 with a primary completion date of 2026-09-01.
⚠ 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 project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.
Eligibility Criteria
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study * Treated in the ED during screening hours * Meet DSM-5 diagnostic criteria for moderate to severe OUD * Clinical Opioid Withdrawal Score (COWS) score ≥ 8 * Urine toxicology positive for fentanyl * Able to speak English or Spanish sufficiently to understand study procedures Exclusion Criteria: * UDS positive for methadone. * Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing * Have an unstable medical or psychiatric condition including suicidality requiring hospitalization * Require ongoing opioids for pain management * Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible * Be a prisoner or in custody at the time of the index visit * Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures. * Unable to provide one additional point of contact other than themselves * Unwilling to follow study procedures * Have prior enrollment in the current study * Have a known allergy or hypersensitivity to BUP * Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA) * Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration * Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study
Contact & Investigator
Ethan Cowan, MD, MS
PRINCIPAL INVESTIGATOR
The Rutgers Addiction Research Center
Frequently Asked Questions
Who can join the NCT05589181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT05589181 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 140 participants.
Is NCT05589181 currently recruiting?
Yes, NCT05589181 is actively recruiting participants. Contact the research team at ethan.cowan@rutgers.edu for enrollment information.
Where is the NCT05589181 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT05589181 clinical trial?
NCT05589181 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Ethan Cowan, MD, MS at The Rutgers Addiction Research Center. The trial plans to enroll 140 participants.