Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
BISTRO
3 other identifiers
interventional
512
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedStudy Start
First participant enrolled
August 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
June 8, 2026
June 1, 2026
1.5 years
June 1, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-month Buprenorphine treatment retention (3-month retention)
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.
Between baseline and 1-month following intervention, and between baseline and 3-months following intervention
Secondary Outcomes (18)
Buprenorphine Adherence
Baseline to 3-months following intervention
6-month Buprenorphine Treatment Retention (6-month retention)
From baseline to 6-months following intervention
Treatment and Recovery Activities
6-months following intervention
Non-prescribed Opioid Use
1-month, 3-months, and 6-months following intervention
Overdose (non-fatal and fatal)
6-months following intervention
- +13 more secondary outcomes
Study Arms (2)
Treatment As Usual (TAU)
ACTIVE COMPARATORParticipants 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.
Low-threshold Buprenorphine (LTB)
EXPERIMENTALAfter 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- National Institute on Drug Abuse (NIDA)collaborator
- New York Universitycollaborator
- The Emmes Company, LLCcollaborator
Study Sites (8)
Community Health Project Los Angeles (CHPLA)
Los Angeles, California, 90029, United States
HIPS
Washington D.C., District of Columbia, 20002, United States
CARPBR/Be Safe Syringe Program
Baton Rouge, Louisiana, 70806, United States
Harm Reduction Sisters
Duluth, Minnesota, 55805, United States
Alianza of New Mexico
Roswell, New Mexico, 88203, United States
HIV Alliance
Grants Pass, Oregon, 97526, United States
Challenges, Inc/Prisma Health
Greenville, South Carolina, 29605, United States
Vivent Health
Milwaukee, Wisconsin, 53212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron D Fox, MD, MS
Albert Einstein College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 8, 2026
Study Start (Estimated)
August 10, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Datasets will be available when either (1) the primary outcome paper has been accepted for publication, (2) the data has been locked for more than 18 months, or (3) the grant concludes; whichever comes first. Datasets will remain accessible via the National Institute on Drug Abuse (NIDA) Data Share contingent on NIDA's continued support of the archive. To date, NIDA Data Share has not deleted any deposited data.
- Access Criteria
- Access to the scientific data will be controlled via a registration agreement for data use on the NIDA Data Share Website. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
De-identified demographic, clinical, laboratory, survey, qualitative data collected from case report forms (CRFs) will be preserved and shared. The following data will be preserved but not shared as they may contain a large volume of personally identifiable information (PII): data derived from qualitative interviews, participant locator and other administrative forms. Likewise, data from all free-text and/or comments fields will not be shared due to the nature of the data and risk of exposing PI. Scientific data will be processed and analyzed with Statistical Analysis System (SAS) software and shared in SAS and ASCII formats.