Onsite Buprenorphine Treatment at Syringe Exchange Programs (O-BMT)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Opiate Addiction

Treatments: Drug: Buprenorphine; Behavioral: Onsite treatment; Behavioral: Enhanced referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03150173

2017-7484

R01DA044878 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

O-BMT (onsite treatment)

Experimental group

Description:

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

Treatment:

Behavioral: Onsite treatment

Drug: Buprenorphine

Enhanced Referral

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced referral

Drug: Buprenorphine