Skip to main content
OpenTrials
Completed

NCT Number: NCT03150173

Onsite Buprenorphine Treatment at Syringe Exchange Programs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opiate Addiction Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York Harm Reduction Educators, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Onsite treatment

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.

Enhanced Referral

Behavioral

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

buprenorphine

Drug

all participants will receive buprenorphine

Primary outcomes

  1. Buprenorphine Engagement

    Time frame: 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 outcomes

  1. Treatment Retention

    Time frame: 6 months

    Treatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm.

  2. HIV Risk Behaviors

    Time frame: 6 months

    Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection 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) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm.

  3. Buprenorphine Diversion

    Time frame: 6 months

    Buprenorphine 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 during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm.

  4. Incremental Cost-effectiveness Ratio (ICER)

    Time frame: 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. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure).

  5. Quality-adjusted Life-years (QALYs) Gained

    Time frame: 6 months

    The main 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. Mean years gained are summarized by study arm.

  6. Mean Difference in Total Costs

    Time frame: 6 months

    Mean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm.

  7. Time to First Buprenorphine Prescription

    Time frame: 1 month

    Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics.

  8. Number/Percentage of Participants Who Received Any Buprenorphine Prescription

    Time frame: 6 months

    The Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm.

  9. Total Time Prescribed Buprenorphine

    Time frame: 6 months

    Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: O-BMT

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
May 12, 2017
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.