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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Buprenorphine

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yale University

Lead sponsor

Braeburn Pharmaceuticals

Collaborator