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.
Age ≥ 18 years of age at Visit 1.
Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) Criteria for Opioid Use Disorder
Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline,
Fentanyl-positive urine drug screening at baseline,
Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
Methadone-positive urine drug screening at baseline
Buprenorphine-positive urine drug screening at baseline
Be unable to provide any locator or contact information at least one contact in addition to themselves
University of California, San Francisco
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator