Starting buprenorphine treatment for opioid use disorder in patients using fentanyl

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if buprenorphine can be safely initiated in patients with opioid use disorder who are actively using fentanyl, without causing withdrawal symptoms. Participants will be monitored in a research unit and randomly assigned to either a standard initiation protocol or a new rapid outpatient low-dose initiation approach. The study will assess the effectiveness and safety of these two methods in managing opioid use disorder. Eligible participants must have moderate to severe opioid use disorder and test positive for fentanyl.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pennsylvania Center for Studies of Addiction
  Philadelphia, Pennsylvania, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.