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NCT06379984 · ClinicalTrials.gov registry record · Phase 2
Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use
A Phase 2 study of Opioid Use Disorder, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06379984 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 60 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06379984, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test. Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI). For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8 mg twice daily (or up to three times daily). This is the current standard of care. For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8mg twice daily (or up to three times daily). The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation.
Conditions Studied
Interventions
- DRUG Buprenorphine
Study Locations (1)
Pennsylvania
- University of Pennsylvania Center for Studies of Addiction - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-05-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06379984
The ClinicalTrials.gov registry entry for NCT06379984 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 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 (99% lower). The listed sponsor is University of Pennsylvania, which has 1,423 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 1 intervention - of which Buprenorphine is the first listed.
NCT06379984 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06379984 about?
NCT06379984 is a clinical study titled "Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use". The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug te...
What is the current status of trial NCT06379984?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-05-08. Estimated completion is 2026-12-31.
What conditions does trial NCT06379984 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06379984?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT06379984?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06379984 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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