NCT06316830

Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose

Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine	Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.

Timeline

• Start date: 2025-01-06
• Primary completion: 2027-08-01
• Completion: 2027-11-01
• First posted: 2024-03-18
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study