NCT05589181 · Rutgers, The State University of New Jersey
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
What this study 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).
View original scientific description
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).
Interventions
DRUG
High Dose Buprenorphine
32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose
DRUG
Standard Buprenorphine Dose
12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose
Primary outcome measures
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
Time frame: 7 days post-ED visit
The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 in
Where
- Newark, New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2025 · Source of record for eligibility and locations