Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Montefiore Medical Center
- Study ID
- NCT07631598
- Status
- Not Yet Recruiting
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Conditions
- Opioid Use Disorder
- Opioid Use Disorder, Moderate
- Opioid Use Disorder, Severe
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Standard of Care Referral — OTHERDuring 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.
- Low Threshold Buprenorphine — BEHAVIORALDuring 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.
Study Details
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.
Key Dates
- Start date
- Aug 10, 2026
- Status verified
- Jun 2026
- Primary completion
- Feb 29, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 512 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Treatment As Usual (TAU)Participants enrolled before the intervention is implemented at each syringe service program (SSP) will receive standard of care, consisting of referral to community-based buprenorphine treatment providers. SSP staff will offer information and referral support but will not provide on-site buprenorphine treatment or prescribing.
- Experimental: Low-threshold Buprenorphine (LTB)After implementation at each SSP site, participants will have access to on-site, low-threshold buprenorphine treatment integrated into SSP services. This model focuses on minimizing barriers to treatment initiation and retention and includes , flexible policies and procedures and collaboration with a peer outreach worker.
Primary Outcome Measure
3-month Buprenorphine treatment retention (3-month retention) [ Time Frame: Between baseline and 1-month following intervention, and between baseline and 3-months following intervention ]
Central Contacts
- Megan M Ghiroli12036068136
- Aaron D Fox, MD, MS718-920-7173
Locations (8)
| Facility | City | State | ZIP |
|---|---|---|---|
| Community Health Project Los Angeles (CHPLA) | Los Angeles | California | 90029 |
| HIPS | Washington D.C. | District of Columbia | 20002 |
| CARPBR/Be Safe Syringe Program | Baton Rouge | Louisiana | 70806 |
| Harm Reduction Sisters | Duluth | Minnesota | 55805 |
| Alianza of New Mexico | Roswell | New Mexico | 88203 |
| HIV Alliance | Grants Pass | Oregon | 97526 |
| Challenges, Inc/Prisma Health | Greenville | South Carolina | 29605 |
| Vivent Health | Milwaukee | Wisconsin | 53212 |
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