Testing higher doses of buprenorphine for treating opioid use disorder
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
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 |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06316830 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, incarcerated, or have allergies to buprenorphine will not benefit from this study.
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 performed: Other studies have explored buprenorphine dosing, but this specific high-dose approach in the context of fentanyl use is relatively novel.
Eligibility criteria
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 this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Jackie Goldman
- Email: jacqueline_goldman1@brown.edu
- Phone: 401-808-6950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.