Testing higher doses of buprenorphine for treating opioid use disorder
Official title: 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
Run by Rhode Island Hospital · NCT06316830 · Data updated 2026-11-12
This study tests if a higher daily dose of buprenorphine can help people with opioid use disorder, especially those who have used fentanyl, feel better and stay in treatment longer compared to the standard dose.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Status | Recruiting |
| Started | January 6, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | October 23, 2025 |
| Trial ID | NCT06316830 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 18 and older with moderate to severe opioid use disorder and a history of fentanyl use.
✕Probably not a fit
Patients who are pregnant, incarcerated, or have allergies to buprenorphine will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of a higher daily dose of buprenorphine (24 mg) compared to the standard dose (16 mg) in patients with opioid use disorder, particularly those with a history of fentanyl use. Participants will be randomly assigned to receive either dose, and the study will measure outcomes such as treatment retention, opioid use, cravings, and overdose risk. The goal is to determine if the higher dose leads to better treatment outcomes and reduced overdose incidents.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with opioid use disorder, potentially reducing overdose rates.
How similar studies have gone: Other studies have explored buprenorphine dosing, but this specific high-dose approach in the context of fentanyl use is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Brown University
Providence, Rhode Island, United States Recruiting
Study contacts
- Study coordinator: Jackie Goldman
- Email: jacqueline_goldman1@brown.edu
- Phone: 401-808-6950
Similar studies
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CBD for Opioid Dependence and Pain on Buprenorphine
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CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand
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STORC: Training a support person plus patient navigation after birth
We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.
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Personalized Addiction Treatment Enhancement for Opioid Use Disorder
A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.