Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses

NCT07631598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2026-08-21

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631598 on ClinicalTrials.gov