Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder
• Interventions: Drug: Buprenorphine

• Registration Number: NCT07176351
• Lead Sponsor: Yale University

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 community receiving care on a mobile pharmacy clinic (MPC).

Participants who are interested in initiating monthly or weekly injections of subcutaneous XR-B (BRIXADI) as a treatment for their OUD will be enrolled in a 6-month study assessing the acceptability and feasibility of receiving XR-B on an MPC.

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 to determine the acceptability and feasibility of being able to provide XR-B from the first mobile pharmacy clinic in the nation. Medical visit data will be collected for 6 months along with medical record data.

BRIXADI (by Braeburn), subcutaneous long-acting buprenorphine in weekly and monthly formulations will be used for this project. Participants will be engaged in shared decision making with a project clinician regarding the weekly or monthly formulation. Dosing will be based on medical need. Participants will be able to access to free medication for 6 months.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-12-01
• Primary Completion: 2027-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Buprenorphine	Buprenorphine	Participants will be offered weekly or monthly Buprenorphine injections

Primary Outcome Measures

Name	Time	Method
Retention of XR-B at month 6	Month 6	Proportion of participants that were retained on 6 months of XR-B injections.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States