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

Primary Purpose

Opiate Addiction

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Onsite treatment
Enhanced referral
Buprenorphine
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring opioid use disorder, syringe exchange, HIV risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • BOOM!Health Harm Reduction Center
  • Washington Heights CORNER Project
  • New York Harm Reduction Educators

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

O-BMT (onsite treatment)

Enhanced Referral

Arm 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

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

Outcomes

Primary Outcome Measures

Buprenorphine Engagement
Having an active buprenorphine prescription at 30 days after randomization

Secondary Outcome Measures

Treatment Retention
Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation
HIV risk behaviors
Change in HIV risk behaviors we will be assessed using the HIV risk behavior survey. A dichotomous measure (yes/no) of injecting 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).
Diversion
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.
Incremental cost-effectiveness ratio (ICER)
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.

Full Information

First Posted
May 9, 2017
Last Updated
September 28, 2023
Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03150173
Brief Title
Onsite Buprenorphine Treatment at Syringe Exchange Programs
Acronym
O-BMT
Official Title
Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
opioid use disorder, syringe exchange, HIV risk reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
O-BMT (onsite treatment)
Arm Type
Experimental
Arm 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
Arm Title
Enhanced Referral
Arm Type
Active Comparator
Arm Description
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Intervention Type
Behavioral
Intervention Name(s)
Onsite treatment
Intervention Description
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
Intervention Name(s)
Enhanced referral
Intervention Description
Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
all participants will receive buprenorphine
Primary Outcome Measure Information:
Title
Buprenorphine Engagement
Description
Having an active buprenorphine prescription at 30 days after randomization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Treatment Retention
Description
Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation
Time Frame
6 months
Title
HIV risk behaviors
Description
Change in HIV risk behaviors we will be assessed using the HIV risk behavior survey. A dichotomous measure (yes/no) of injecting 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).
Time Frame
6 months
Title
Diversion
Description
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.
Time Frame
6 months
Title
Incremental cost-effectiveness ratio (ICER)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Fox, MD, MS
Organizational Affiliation
Associate Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
BOOM!Health Harm Reduction Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Washington Heights CORNER Project
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
New York Harm Reduction Educators
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Onsite Buprenorphine Treatment at Syringe Exchange Programs

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