Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic: A Pilot Study
Overview
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
- Drug Buprenorphine
Weekly or monthly extended-release subcutaneous injection
Primary outcome measures
- Retention of XR-B at month 6 [Time frame: Month 6]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale School of Medicine — New Haven
Identifiers
NCT: NCT07176351 · 2000040545