Onsite Buprenorphine Treatment at Syringe Exchange Programs

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opiate Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Onsite treatment

Intervention Type BEHAVIORAL

Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.

Buprenorphine

Intervention Type DRUG

all participants will receive buprenorphine

Enhanced Referral

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

Group Type ACTIVE_COMPARATOR

Enhanced referral

Intervention Type BEHAVIORAL

Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment

Buprenorphine

Intervention Type DRUG

all participants will receive buprenorphine

Interventions

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Onsite treatment

Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.

Intervention Type BEHAVIORAL

Enhanced referral

Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment

Intervention Type BEHAVIORAL

Buprenorphine

all participants will receive buprenorphine

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No