High dose buprenorphine induction for opioid use disorder in the emergency department
Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients
This study is testing if a higher dose of buprenorphine can help people with opioid use disorder in the emergency department feel better and stay engaged in treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT05589181 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a higher induction dose of buprenorphine (BUP) for patients with opioid use disorder in emergency departments. It consists of two trials: the first compares the safety and tolerability of a 32 mg dose against the standard 12 mg dose, while the second is a pilot study assessing the engagement in addiction treatment within 7 days post-induction. Participants will be monitored closely for any adverse effects during and after the dosing. The study aims to determine if a higher dose can improve patient outcomes and engagement in treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate to severe opioid use disorder who are treated in the emergency department and meet specific clinical criteria.
Not a fit: Patients who are pregnant, have unstable medical or psychiatric conditions, or are currently enrolled in formal addiction treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment engagement for patients with opioid use disorder, leading to better recovery outcomes.
How similar studies have performed: Other studies have explored buprenorphine dosing, but this specific high-dose approach in emergency settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newark, New Jersey
- Rutgers University Hospital — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Ethan Cowan, MD, MS — The Rutgers Addiction Research Center
- Study coordinator: Ethan Cowan, MD, MS
- Email: ethan.cowan@rutgers.edu
- Phone: (917) 447-4964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.