Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06316830

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

Led by Rhode Island Hospital · Updated on 2025-10-23

250

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

R

Rhode Island Hospital

Lead Sponsor

B

Brown University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 positive urine drug screen at intake, recent positive urine test while on treatment, or self-reported ongoing fentanyl use
Not Eligible

You will not qualify if you...

  • Previous enrollment in the trial
  • Currently incarcerated or in police custody
  • Pregnant
  • Living outside of Rhode Island (RI)
  • Unable to provide informed consent
  • Allergy to Buprenorphine
  • Use of medications with potential serious interactions as judged by the treating clinician
  • Participants who become incarcerated or in police custody during the study will be withdrawn

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 02912

Actively Recruiting

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Research Team

J

Jackie Goldman

CONTACT

R

Rachel Wightman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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