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NCT Number: NCT07176351

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

buprenorphine

Drug

Weekly or monthly extended-release subcutaneous injection

Other names: BRIXADI

Primary outcomes

  1. Retention of XR-B at month 6

    Time frame: Month 6

    Proportion of participants that were retained on 6 months of XR-B injections.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Di Paola

CONTACT

[email protected]

+1 475-306-1608

Sandra Springer, MD

CONTACT

[email protected]

203-687-6680

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Braeburn Pharmaceuticals

Registry information

Official study title

Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic: A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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