Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
Recruiting now · Phase 2/Phase 3
Conditions studied: Opioid Use Disorder
In brief
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).
Key facts
- Study ID
- NCT06316830
- Run by
- Rhode Island Hospital
- People needed
- 250
- Starts
- 2025-01-06
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2025-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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by the treating clinician *Participants that become incarcerated/or in police custody during the study will be withdrawn.
Where it is running
- Brown University — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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