Acceptability and Feasibility of Extended-Release Subcuta... | NCT07176351

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

NCT07176351

Sponsor

Yale University

Status

Not yet recruiting

Last Update Posted

Apr 3, 2026Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Opioid Use Disorder

Interventions

Buprenorphine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Sep 8, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 3, 2026Actual

Name	Class
Braeburn Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buprenorphine	Experimental	Participants will be offered weekly or monthly Buprenorphine injections	Drug: Buprenorphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug	Weekly or monthly extended-release subcutaneous injection	Buprenorphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention of XR-B at month 6	Proportion of participants that were retained on 6 months of XR-B injections.	Month 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandra Springer, MD	Contact	203-687-6680		sandra.springer@yale.edu
Angela Di Paola	Contact	+1 475-306-1608		angela.dipaola@yale.edu

Overall Officials

Name	Affiliation	Role
Sandra Springer, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale School of Medicine		New Haven	Connecticut	06520	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002047	Buprenorphine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided