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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * English-speaking * Age 18 years-old or older * Identified by the treating physician as having moderate to severe opioid use disorder (OUD) * Initiating or continuing buprenorphine for treatment of opioid use disorder * History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment) Exclusion Criteria: * Previous enrollment in the trial * Incarcerated or in police custody\* * Pregnant * Live outside of Rhode Island (RI) * Unable to provide informed consent * Allergy to Buprenorphine * Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.
About the study
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).
What is being tested
- Buprenorphine (drug)
Sponsor: Rhode Island Hospital · Participants: 250 · Started: Jan 6, 2025
Contact the study team
- Jackie Goldman · Phone: 401-808-6950
Official record on ClinicalTrials.gov — NCT06316830
Locations in the U.S.
| Rhode Island | Brown University, Providence |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.