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

NCT07176351 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2000040545
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Retention of XR-B at month 6

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

  Month 6

Study Arms (1)

Buprenorphine

EXPERIMENTAL

Participants will be offered weekly or monthly Buprenorphine injections

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

Weekly or monthly extended-release subcutaneous injection

Also known as: BRIXADI

Buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• Braeburn Inc: collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sandra Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Springer, MD

CONTACT

203-687-6680; sandra.springer@yale.edu

Angela Di Paola

CONTACT

+1 475-306-1608; angela.dipaola@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)