Recruiting soon

Extended-Release Buprenorphine on Mobile Pharmacy Clinic for Opioid Use Disorder

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What is being tested

Buprenorphine

Drug
Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Opioid-Related Disorders

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorYale University
Study ContactSandra Springer, MDMore contacts
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study aims to explore the use of an extended-release form of buprenorphine, known as BRIXADI, delivered through a mobile pharmacy clinic. It focuses on individuals who may benefit from a sustained-release medication for certain medical needs. The goal is to see if this method of delivery is both acceptable and feasible over a six-month period. This is significant as it could offer a more flexible and accessible way to receive important medication, particularly for those who have difficulty accessing traditional healthcare facilities. Participants in the study will have the option to choose, along with their clinician, whether they want to receive the medication in weekly or monthly doses. The medication is administered as an injection under the skin, and it will be provided at no cost for the duration of the study. Researchers will gather data from medical visits and records over the six months to evaluate how well this approach works. This may help in understanding the benefits and any challenges involved in using a mobile pharmacy clinic to distribute extended-release medications.

Official TitleAcceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic: A Pilot Study
NCT07176351
Principal SponsorYale University
Study ContactSandra Springer, MDMore contacts
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

3 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will be offered weekly or monthly Buprenorphine injections

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yale School of Medicine

New Haven, United StatesOpen Yale School of Medicine in Google Maps
Recruiting soonOne Study Center