Recruiting

BRIXADI

Sponsor:

Yale University

Code:

NCT07176351

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine

Study Details

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

Study ID

NCT07176351

Start date

Sep 23, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Buprenorphine

Participants will be offered weekly or monthly Buprenorphine injections

Interventions

Buprenorphine

Weekly or monthly extended-release subcutaneous injection

Primary outcome measure

  • Retention of XR-B at month 6 [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Sandra Springer, MD

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

Angela Di Paola

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

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Angela Di Paola, PhD

475-306-1608angela.dipaola@yale.edu

More Information

Sponsor

Yale University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.