NCT07631598 Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
| NCT ID | NCT07631598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 512 participants |
| Start Date | 2026-08-17 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 512 participants in total. It began in 2026-08-17 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years old; 2. Meet DSM-5 criteria for moderate or severe OUD; 3. Interest in receiving buprenorphine treatment; 4. Speaks English or Spanish; 5. Currently an SSP client at the time of enrollment; 6. Ability to provide informed consent. Exclusion Criteria: 1. Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment; 2. Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care; 3. Allergy to buprenorphine; 4. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.
Contact & Investigator
Aaron D Fox, MD, MS
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine
Frequently Asked Questions
Who can join the NCT07631598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07631598 currently recruiting?
Yes, NCT07631598 is actively recruiting participants. Contact the research team at mghiroli@montefiore.org for enrollment information.
Where is the NCT07631598 trial being conducted?
This trial is being conducted at Los Angeles, United States, Washington D.C., United States, Baton Rouge, United States, Duluth, United States and 4 additional locations.
Who is sponsoring the NCT07631598 clinical trial?
NCT07631598 is sponsored by Montefiore Medical Center. The principal investigator is Aaron D Fox, MD, MS at Albert Einstein College of Medicine. The trial plans to enroll 512 participants.