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NCT05589181 · ClinicalTrials.gov registry record · Phase 3
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
A Phase 3 study of Opioid Use Disorder, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05589181: Recruiting Phase 3 study of Opioid Use Disorder, sponsored by Rutgers, The State University of New Jersey.
NCT05589181 is a Phase 3 study of Opioid Use Disorder that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 140 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05589181, a Phase 3 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program.
Conditions Studied
Interventions
- DRUG High Dose Buprenorphine
- DRUG Standard Buprenorphine Dose
Study Locations (1)
New Jersey
- Rutgers University Hospital - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2023-04-06 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What NCT05589181 shows while recruiting
NCT05589181 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which High Dose Buprenorphine is the first listed.
NCT05589181 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05589181 about?
NCT05589181 is a clinical study titled "High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)". 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-h...
What is the current status of trial NCT05589181?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2023-04-06. Estimated completion is 2026-12-31.
What conditions does trial NCT05589181 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT05589181?
The interventions under investigation include: High Dose Buprenorphine (DRUG), Standard Buprenorphine Dose (DRUG).
Who is sponsoring clinical trial NCT05589181?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05589181 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05589181's enrollment target sits among peer trials
140 114th of 257 higher than 144 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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