Opioid Use Disorder
Conditions
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.
Interventions
DRUGBuprenorphine
Weekly or monthly extended-release subcutaneous injection
Sponsors
Yale University
Braeburn Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of XR-B at month 6 | Month 6 | Proportion of participants that were retained on 6 months of XR-B injections. |
Countries
United States
Contacts
CONTACTSandra Springer, MD
CONTACTAngela Di Paola
PRINCIPAL_INVESTIGATORSandra Springer, MD
Yale University
Outcome results
None listed