Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
NCT07631598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512
Last updated 2026-08-21
Summary
This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.
The study compares two ways of connecting people to treatment:
Referral to a community treatment provider (usual care before the new program begins).
Onsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.
Participants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.
The study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.
The overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.
Conditions
- Opioid Use Disorder
- Opioid Use Disorder, Severe
- Opioid Use Disorder, Moderate
Interventions
- OTHER
-
Standard of Care Referral
During the pre-implementation phase, SSP staff will refer participants with opioid use disorder to external community providers for buprenorphine treatment. Services offered include information, referral assistance, and linkage to care, but buprenorphine will not be initiated or managed at the SSP site.
- BEHAVIORAL
-
Low Threshold Buprenorphine
During the post-implementation phase, SSPs will implement a low-threshold model of care for buprenorphine treatment. This model includes: Low barrier to entry Flexible scheduling and follow-up procedures Risk reduction counseling Collaboration with a peer outreach worker Training and technical assistance for SSP staff and clinicians to deliver care in non-traditional, low-barrier settings This intervention focuses on implementing and evaluating a service delivery model to expand access to medication for opioid use disorder within SSPs.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
New York University
collaborator OTHER -
The Emmes Company, LLC
collaborator INDUSTRY -
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Aaron D Fox, MD, MS · Albert Einstein College of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-08-17
- Primary Completion
- 2028-02-29
- Completion
- 2028-06-30
Countries
- United States
Study Locations
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