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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05589181
The ClinicalTrials.gov registry entry for NCT05589181 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.