Status:
NOT_YET_RECRUITING
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Lead Sponsor:
Yale University
Collaborating Sponsors:
Braeburn Inc
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This exploratory project will assess the acceptability and feasibility of monthly extended-release subcutaneous buprenorphine (BRIXADI; XR-B) to treat opioid use disorder (OUD) among persons in the co...
Detailed Description
This is a prospective cohort study, participants will be able to have a shared decision with the clinician if they would like to receive XR-B. The medication would be available for free for 6 months t...
Eligibility Criteria
Inclusion
- Able to provide written informed consent in English or Spanish
- Current or history of DSM-5 moderate-to-severe OUD per Rapid Opioid Use Disorder Assessment (ROUDA)
- Not planning to move out of state or to new location during study enrollment.
Exclusion
- Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment)
- Persons who are pregnancy
- People who show violent or threatening behavior toward staff and/or others
- Allergy, hypersensitivity, or medical contraindication to medication (the BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in persons with latex-sensitivity)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07176351
Start Date
December 1 2025
End Date
February 1 2027
Last Update
September 16 2025
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06520