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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Previous enrollment in the trial

Incarcerated or in police custody*

Pregnant

Live outside of Rhode Island (RI)

Trial design

Treatments tested in this trial

  • Buprenorphine

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rhode Island Hospital

Lead sponsor

Brown University

Collaborator