Onsite Buprenorphine Treatment at Syringe Exchange Programs
- Conditions
- Opiate Addiction
- Interventions
- Registration Number
- NCT03150173
- Lead Sponsor
- Montefiore Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description O-BMT (onsite treatment) 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 Enhanced Referral Enhanced referral In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment O-BMT (onsite treatment) Buprenorphine 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 Enhanced Referral Buprenorphine In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
- Primary Outcome Measures
Name Time Method Buprenorphine Engagement 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 Outcome Measures
Name Time Method Treatment Retention 6 months Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation
HIV Risk Behaviors 6 months Change in HIV risk behaviors we will be assessed using the HIV risk behavior survey. A dichotomous measure (yes/no) of injecting risk will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes).
Diversion 6 months Diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion.
Incremental Cost-effectiveness Ratio (ICER) 6 months The ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure.
Trial Locations
- Locations (3)
New York Harm Reduction Educators
🇺🇸New York, New York, United States
BOOM!Health Harm Reduction Center
🇺🇸Bronx, New York, United States
Washington Heights CORNER Project
🇺🇸New York, New York, United States