Clinical trial NCT03150173: Onsite Buprenorphine Treatment at Syringe Exchange Programs
Official title: Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Addiction
Keywords: opioid use disorder, syringe exchange, HIV risk reduction
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years
2. opioid use disorder
3. interest in buprenorphine treatment
4. motivation for opioid use disorder treatment
5. willingness to accept community health center referral
6. syringe exchange participant

Exclusion Criteria:

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

Primary outcomes:
measure: Buprenorphine Engagement
timeFrame: 30 days after randomization
Secondary outcomes:
measure: Treatment Retention
timeFrame: 6 months
measure: HIV Risk Behaviors
timeFrame: 6 months
measure: Diversion
timeFrame: 6 months
measure: Incremental Cost-effectiveness Ratio (ICER)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: BOOM!Health Harm Reduction Center
state: New York
city: New York
country: United States
facility: Washington Heights CORNER Project
state: New York
city: New York
country: United States
facility: New York Harm Reduction Educators
state: New York
Study officials:
affiliation: Associate Professor of Medicine
name: Aaron Fox, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.