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NCT Number: NCT06379984

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 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, 0.5, 0.5, 0.5, 2, 16 mg with doses scheduled every 2 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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Kyle M Kampman, MD

CONTACT

[email protected]

1 215 746 2764

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Sublingual buprenorphine

Primary outcomes

  1. Initiation of buprenorphine maintenance without precipitated withdrawal

    Time frame: 10 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: ROLDI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 23, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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