Recruiting

Buprenorphine

Sponsor:

Montefiore Medical Center

Code:

NCT07631598

Conditions

Opioid Use Disorder

Opioid Use Disorder, Severe

Opioid Use Disorder, Moderate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard of Care Referral

Low Threshold Buprenorphine

Study Details

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.

Conditions

Opioid Use Disorder

Opioid Use Disorder, Severe

Opioid Use Disorder, Moderate

Study ID

NCT07631598

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

512 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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 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 and Locations

Central contacts

Megan M Ghiroli

12036068136mghiroli@montefiore.org

Aaron D Fox, MD, MS

adfox@montefiore.org

Locations

Community Health Project Los Angeles (CHPLA)

Recruiting

Los Angeles, California, United States, 90029

Contacts

Site PI

323-380-5469info@chpla.org

Principal Investigator:

Amanda Cowan, MSc

HIPS

Recruiting

Washington D.C., District of Columbia, United States, 20002

Contacts

Phyllis Bijole

202-834-3289phyllis@hips.org

CARPBR/Be Safe Syringe Program

Recruiting

Baton Rouge, Louisiana, United States, 70806

Contacts

Site PI

225-775-7988gjvar.carpbr@gmail.com

Principal Investigator:

Gjvar Payne

Harm Reduction Sisters

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Jack Research Coordinator

218-206-6482jack@harmreductionsisters.org

Principal Investigator:

Sue Purchase

Alianza of New Mexico

Recruiting

Roswell, New Mexico, United States, 88203

Contacts

Ryan Nix Site PI

575-623-1995ryan.nix@alianzanm.org

Principal Investigator:

Ryan Nix

HIV Alliance

Recruiting

Grants Pass, Oregon, United States, 97526

Contacts

Harmony Beckett

541-342-5088hbeckett@allianceor.org

Principal Investigator:

Harmony Beckett

Challenges, Inc/Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Liam Diaz, MPH

864-915-2528Liam.Diaz@prismahealth.org

Principal Investigator:

Alain Litwin, MD

Vivent Health

Recruiting

Milwaukee, Wisconsin, United States, 53212

Contacts

Site PI

800-359-9272ctgov.research@viventhealth.org

Principal Investigator:

Mikaela Becker

More Information

Sponsor

Montefiore Medical Center

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Buprenorphine
  • Overdose Prevention
  • Low-Threshold Treatment
  • Community-Based Treatment
  • Medication for Opioid Use Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.