Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
ConditionOpioid Use Disorder
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Buprenorphine
DrugWeekly or monthly extended-release subcutaneous injection
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: BuprenorphineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Retention of XR-B at month 6
Proportion of participants that were retained on 6 months of XR-B injections.
Time frame
Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Braeburn Pharmaceuticals
Collaborator
Source ClinicalTrials.gov