NCT07631598 · Montefiore Medical Center
Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
(BISTRO)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
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
Buprenorphine (BUP) treatment retention will be defined as having an active buprenorphine prescription between baseline and 1-month and between the 1-month (days 1-30) and 3-month (days 31-90) time points. Participants will be asked to provide evidence of BUP prescriptions at study visits (i.e., confirmed prescriptions). If a participant receives a second BUP prescription before the 1-month follow-up and the number of days dispensed covers dates after day 30 (i.e., carries over into the 31-90 days interval), this participant will have met the primary outcome. The primary outcome will require at least one day of an active BUP prescription based on confirmed prescriptions within the 2 time-points. BUP treatment retention will be summarized as a binary ("Yes/No") variable. The number/percentage of participants who are retained at each timepoint will be summarized by arm. BUP treatment retention is the primary measure of effectiveness.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years old;
- Meet DSM-5 criteria for moderate or severe OUD;
- Interest in receiving buprenorphine treatment;
- Speaks English or Spanish;
- Currently an SSP client at the time of enrollment;
- Ability to provide informed consent.
Exclusion criteria
- Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;
- Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;
- Allergy to buprenorphine;
- 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.
Where
- Los Angeles, California
- Washington D.C., District of Columbia
- Baton Rouge, Louisiana
- Duluth, Minnesota
- Roswell, New Mexico
- Grants Pass, Oregon
- Greenville, South Carolina
- Milwaukee, Wisconsin
Collaborators
National Institute on Drug Abuse (NIDA), New York University, The Emmes Company, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations