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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: Recruiting Phase 2 study of Opioid Use Disorder, sponsored by University of Pennsylvania.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The proportion of subjects who complete buprenorphine initiation without precipitated withdrawal. Completing buprenorphine initiation is defined as reaching 8mg or more total daily dose of sublingual buprenorphine without termination of buprenorphine initiation for any reason. Precipitated withdrawal is defined as an increase in COWS of 6 or more (compared to the COWS immediately preceding the most recent dose of buprenorphine) within 2 hours of the most recent dose of sublingual buprenorphine.

Conditions Studied

Opioid Use Disorder

Interventions

  • DRUG Buprenorphine

Study Locations (1)

Pennsylvania

  • University of Pennsylvania Center for Studies of Addiction - Philadelphia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-05-08
Est. Completion 2026-12-31
Phase Phase 2
University of Pennsylvania

1,423 total trials

What NCT06379984 shows while recruiting

NCT06379984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

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 NCT06379984's enrollment target sits among peer trials

60 156th of 257 higher than 91 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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More recruiting context for NCT06379984

Source: ClinicalTrials.gov NCT06379984, the US trial registry maintained by the National Library of Medicine. NCT06379984 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.