Phase 2 N=97 Randomized Treatment

Onsite Buprenorphine Treatment at Syringe Exchange Programs

Opiate Addiction

Bottom Line

View on ClinicalTrials.gov: NCT03150173 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Jan 2025

Primary outcome: Primary: Buprenorphine Engagement — 19; 19 Participants — p=0.94

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Onsite treatment (Behavioral); Enhanced referral (Behavioral); Buprenorphine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Buprenorphine Engagement	19; 19	0.94
SECONDARY Treatment Retention	2; 6	0.148
SECONDARY HIV Risk Behaviors	5; 4	0.6132
SECONDARY Buprenorphine Diversion	8; 2	.051
SECONDARY Incremental Cost-effectiveness Ratio (ICER)	-805067	—
SECONDARY Quality-adjusted Life-years (QALYs) Gained	0.20; 0.17	0.10
SECONDARY Mean Difference in Total Costs	2702.43; 26853.97	< 0.01 sig
SECONDARY Time to First Buprenorphine Prescription	3.0; 14.0	0.011 sig
SECONDARY Number/Percentage of Participants Who Received Any Buprenorphine Prescription	36; 29	0.098
SECONDARY Total Time Prescribed Buprenorphine	46.7; 56.6	0.256

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03150173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.