Clinical Trial

Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation

Study acronym: COPILOT
Not Yet Recruiting Phase 4
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Summary
The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to: 1. Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and 2. Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability. Participants will: 1. Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic, 2. Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and 3. Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.
Trial Details
NCT Number NCT07469501
Lead Sponsor University of California, San Francisco
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder, Fentanyl
Enrollment 50 participants
Start Date 2026-06
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-13