NCT03150173

Onsite Buprenorphine Treatment at Syringe Exchange Programs

Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opiate Addiction

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Enhanced referral	Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
DRUG	Buprenorphine	all participants will receive buprenorphine

Timeline

• Start date: 2019-01-02
• Primary completion: 2023-10-11
• Completion: 2024-03-31
• First posted: 2017-05-12
• Last updated: 2025-12-11
• Results posted: 2025-01-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study