Onsite Buprenorphine Treatment at Syringe Exchange Programs

NCT03150173 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2017-7484R01DA044878
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.

Conditions

Opiate Addiction

Keywords

opioid use disorder, syringe exchange, HIV risk reduction

Outcome Measures

Primary Outcomes (1)

• Buprenorphine Engagement

  Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.

  30 days after randomization

Secondary Outcomes (9)

• Treatment Retention

  6 months

• HIV Risk Behaviors

  6 months

• Buprenorphine Diversion

  6 months

• Incremental Cost-effectiveness Ratio (ICER)

  6 months

• Quality-adjusted Life-years (QALYs) Gained

  6 months

Study Arms (2)

O-BMT (onsite treatment)

EXPERIMENTAL

Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment

Behavioral: Onsite treatment; Drug: Buprenorphine

Enhanced Referral

ACTIVE COMPARATOR

In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment

Behavioral: Enhanced referral; Drug: Buprenorphine

Interventions

Onsite treatment BEHAVIORAL

Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.

O-BMT (onsite treatment)

Enhanced referral BEHAVIORAL

Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment

Enhanced Referral

Buprenorphine DRUG

all participants will receive buprenorphine

Enhanced Referral; O-BMT (onsite treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• opioid use disorder
• interest in buprenorphine treatment
• motivation for opioid use disorder treatment
• willingness to accept community health center referral
• syringe exchange participant

You may not qualify if:

• receiving opioid agonist treatment in the past 30 days (confirmed by New York Prescription Drug Monitoring Program);
• inability to provide informed consent
• unstable mental illness (e.g., suicidality, psychosis, etc.)
• severe alcohol use disorder or benzodiazepine use disorder by the Diagnostic and Statistical Manual of Mental disorders, Fifth Edition (DSM-5) criteria
• hypersensitivity to buprenorphine or naloxone.
• pregnancy (confirmed via urine testing)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Washington Heights CORNER Project

New York, New York, 10033, United States

Location

New York Harm Reduction Educators

New York, New York, 10035, United States

Location

BOOM!Health Harm Reduction Center

The Bronx, New York, 10451, United States

Location

Related Publications (1)

• Perez-Correa A, Abbas B, Riback L, Ghiroli M, Norton B, Murphy S, Jakubowski A, Hayes BT, Cunningham CO, Fox AD. Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. Contemp Clin Trials. 2022 Mar;114:106674. doi: 10.1016/j.cct.2021.106674. Epub 2022 Jan 3.

  PMID: 34990854 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Aaron D. Fox, Professor, General Internal Medicine
• Organization: Montefiore Medical Center

adfox@montefiore.org

718-920-7173

Study Officials

• Aaron Fox, MD, MS

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: January 2, 2019
• Primary Completion: October 11, 2023
• Study Completion: March 31, 2024
• Last Updated: December 11, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)