Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 97
- Locations
- 3
- Primary Endpoint
- Buprenorphine Engagement
Study Overview
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.
Detailed Description
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, 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. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
O-BMT (onsite treatment)
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
Intervention: Onsite treatment (Behavioral)
O-BMT (onsite treatment)
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
Intervention: Buprenorphine (Drug)
Enhanced Referral
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Intervention: Enhanced referral (Behavioral)
Enhanced Referral
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Intervention: Buprenorphine (Drug)
Outcomes
Primary Outcomes
Buprenorphine Engagement
Time Frame: 30 days after randomization
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.
Secondary Outcomes
- Treatment Retention(6 months)
- Incremental Cost-effectiveness Ratio (ICER)(6 months)
- Quality-adjusted Life-years (QALYs) Gained(6 months)
- Mean Difference in Total Costs(6 months)
- Time to First Buprenorphine Prescription(1 month)
- HIV Risk Behaviors(6 months)
- Buprenorphine Diversion(6 months)
- Total Time Prescribed Buprenorphine(6 months)
- Number/Percentage of Participants Who Received Any Buprenorphine Prescription(6 months)