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
Parallel
Injectable buprenorphine
DrugStarting dose (8-32mg) of long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly maintenance doses (e.g., 128mg Brixadi or 300mg Sublocade)
Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
DrugStarting dose (0.5mg) of sublingual buprenorphine tablets in blister packs (Brixadi or Sublocade) on day 1, followed by 0.5-1.0mg daily increases in week 1 and maintenance dosing based on shared decision-making with provider
Continuous retention in outpatient buprenorphine treatment by day 90
Receiving continuous treatment with buprenorphine sublingual prescriptions or injections administrations during the 90 days of follow up post-randomization as intended-to-treat. A period without buprenorphine treatment ≥8 days will be considered treatment discontinuation. Number of days of continuous treatment with the site clinician prescribing sublingual or injectable buprenorphine treatment during the 90 days post-randomization among RCT participants
Self-reported protocol satisfaction at day 7
Patient-reported satisfaction with buprenorphine initiation protocol measured by Likert-scale satisfaction survey administered on day 7 follow-up visit
Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90
Similar to the primary intention to treat analysis, though we will be analyzing data and individuals based on actual protocol received and treated, rather than assigned treatment at randomization
Successful buprenorphine initiation within first 7 days
Defined as successfully completing buprenorphine initiation. For LDI treatment arm, this means self-reported completion of initiation "blister pack" during Days 1-6 at clinical follow up and pick up of buprenorphine refill based on prescription data. For DTI, this means administration of initial weekly BRIXADI injection and subsequent monthly BRIXADI or SUBLOCADE buprenorphine injection within 7 days of the initial weekly injection.
Fentanyl use during days 1-7 determiend by urinary drug screen
Concurrent fentanyl use during days 1-7 following buprenorphine initiation, determined by urinary drug screen at day 7 follow-up visit.
Fentanyl use during days 8-30 determined by urinary drug screen
Concurrent fentanyl use during days 8-30 following buprenorphine initiation, determined by urinary drug screen at day 30 follow-up visit.
Overall number of adverse events in each arm within 30 days, and by relatedness to study intervention
Number of adverse events within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention.
Number of serious adverse events in each arm in 30 days, and by relatedness to the study intervention
Number of serious adverse events within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention.
Number of ED visits and hospital admissions in each arm in 30 days, and by relatedness to study intervention
Number of emergency department visits and hospital admissions within 30 days, coded by body system and MedDRA classification. All adverse events reported by participants or identified through clinical documentation will be recorded and categorized by severity, duration, and relationship to the study intervention.
Number of fatal opioid overdose events occurring during the 90-day follow-up period, by study arm
Documented deaths due to opioid overdose during the 90-day follow-up period will be identified through the EHR and, if available, linkage to external death records.
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University of California, San Francisco
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
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