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

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).

NCT Number	NCT06316830
Lead Sponsor	Rhode Island Hospital Collaborators: Brown University
Conditions	Opioid Use Disorder
Enrollment	250 participants
Start Date	2025-01-06
Primary Completion	2027-08-01 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-23