Actively Recruiting
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
Led by Rutgers, The State University of New Jersey · Updated on 2025-10-23
140
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent indicating understanding of the study
- Treated in the Emergency Department during screening hours
- Meet DSM-5 criteria for moderate to severe opioid use disorder
- Clinical Opioid Withdrawal Score (COWS) of 8 or higher
- Urine test positive for fentanyl
- Able to speak English or Spanish well enough to understand study procedures
You will not qualify if you...
- Urine drug screen positive for methadone
- Pregnant as determined by urine pregnancy test
- Unstable medical or psychiatric condition requiring hospitalization, including suicidality
- Require ongoing opioid treatment for pain
- Enrolled in formal addiction treatment with medication for opioid use disorder in the last 30 days
- Prisoner or in custody at the time of the visit
- Pending legal issues that prevent full participation
- Unable to provide contact information for one reliable person besides self
- Unwilling to follow study procedures
- Prior enrollment in this study
- Known allergy or hypersensitivity to buprenorphine
- Engaged in formal addiction treatment with medication in the 30 days before the visit
- Received naloxone within 60 minutes before first buprenorphine dose
- Currently receiving another investigational treatment or enrolled in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rutgers University Hospital
Newark, New Jersey, United States, 07103
Actively Recruiting
Research Team
E
Ethan Cowan, MD, MS
CONTACT
C
Clare O'Brien-Lambert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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