Starting buprenorphine treatment for opioid use disorder in patients using fentanyl
Rapid Outpatient Low-dose Initiation of Buprenorphine for Individuals With OUD Using Fentanyl
This study tests if starting buprenorphine treatment for people with opioid use disorder who are using fentanyl can be done safely without causing withdrawal symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06379984 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe opioid use disorder who have fentanyl detected in their urine.
Not a fit: Patients who are pregnant, actively lactating, or have significant medical or psychiatric conditions that would preclude participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective way to initiate treatment for patients struggling with opioid use disorder and fentanyl use.
How similar studies have performed: Other studies have explored buprenorphine initiation in opioid use disorder, but this specific rapid outpatient low-dose approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.