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New buprenorphine start aims to sidestep fentanyl withdrawal

NCT ID NCT06379984

Disease control Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests a new method called ROLDI (rapid outpatient low-dose initiation) for starting buprenorphine in people with opioid use disorder who use fentanyl. The goal is to see if this approach can begin treatment without causing severe withdrawal symptoms. Participants will be randomly assigned to either the standard start or the new ROLDI method in a monitored research unit. The trial focuses on safety, feasibility, and whether the method is acceptable to patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine
What this could lead to
If successful, this approach could make it easier and safer for people using fentanyl to start buprenorphine treatment without severe withdrawal.
What could go wrong
This is a small early-phase trial (60 people) testing feasibility, not effectiveness. The new method may still cause withdrawal or not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pennsylvania Center for Studies of Addiction

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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