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

Launched by UNIVERSITY OF PENNSYLVANIA · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to start treatment with buprenorphine for people who have opioid use disorder (OUD) and are using fentanyl. The trial aims to find out if a method called rapid outpatient low-dose initiation (ROLDI) is safe and effective. Unlike the traditional method, which requires patients to stop using fentanyl for at least 8 hours and experience moderate withdrawal symptoms before starting buprenorphine, ROLDI allows patients to begin the treatment with little to no withdrawal symptoms. This could make it easier for people to start their recovery without going through uncomfortable withdrawal.

To be eligible for this trial, participants need to be 18 years or older, have moderate to severe OUD, and test positive for fentanyl in their urine. They will spend time in a monitored research unit and will be randomly assigned to either the standard treatment or the new ROLDI method. Throughout the trial, participants will receive buprenorphine in small doses, which will gradually increase. The researchers will also collect information about fentanyl levels in the body to better understand how to prevent withdrawal symptoms. This study is currently recruiting participants and aims to gather valuable insights that could lead to more effective treatment options for people struggling with opioid use disorder.

Gender

ALL

Eligibility 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
• • 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