Back to search results

Buprenorphine for Opioid Use Disorder with Fentanyl Use

This study is looking at whether buprenorphine, a medication for opioid use disorder (OUD), can be started safely and quickly in people who also use fentanyl, without causing withdrawal symptoms. To join, you must be 18 or older, have moderate to severe OUD, and have fentanyl detected in your urine. Participants will be admitted to a monitored research unit. You will be randomly assigned to start buprenorphine using either a standard method or a new approach called rapid outpatient low-dose initiation (ROLDI). The main goal is to see if buprenorphine can be started without causing withdrawal within 10 hours.

Study design
This is an interventional study planning to enroll 60 participants. Participants will be randomly assigned to one of two groups: standard buprenorphine initiation or rapid outpatient low-dose initiation (ROLDI).
What's involved
You will be admitted to a monitored research unit for the trial. For standard initiation, you will need to arrive at the unit at least 8 hours after your last fentanyl use.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 10 hours after starting buprenorphine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06379984

Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Pennsylvania
~60 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Buprenorphine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Initiation of buprenorphine maintenance without precipitated withdrawal
Measured over 10 hours

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Kyle M Kampman, MD
[email protected]
1 215 746 2764
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Ages 18 or older
Male, female, transgender, or non-binary
DSM-5 criteria for opioid use disorder, moderate to severe
Fentanyl positive on urine drug test
Able to provide written informed consent in English prior to any study-related procedure

Exclusion

Pregnancy or actively lactating
Previously documented hypersensitivity or allergy to buprenorphine or naloxone
DSM-5 criteria for substance use disorder other than opioid use disorder (e.g., cannabis, cocaine, alcohol)
Current benzodiazepine use
Urine drug testing at screening positive for buprenorphine and/or methadone
AST and/or ALT \>3x upper limit of normal or total bilirubin \>1.5x upper limit of normal
eGFR \<30 mL/min
Use of CYP3A4-metabolized agents such as azole antifungals, macrolides, and protease inhibitors
High risk of severe medetomidine withdrawal based on drug urine testing for medetomidine, prior withdrawal syndrome requiring intensive care unit admission, and/or patient-reported severe nausea/vomiting during early withdrawal, at the discretion of the study physicians.
Significant medical symptoms (e.g. severe respiratory insufficiency), psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participate in the study
Pending legal action that could prohibit participation and/or compliance in study procedures

What this trial measures

  • Initiation of buprenorphine maintenance without precipitated withdrawal10 hours

    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.