NCT07469501

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

Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Fentanyl

Interventions

Type	Name	Description
DRUG	Injectable buprenorphine	Starting 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)
DRUG	Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)	Starting 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

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study