O-BMT: Onsite Buprenorphine Treatment at Syringe Exchange Programs

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03150173

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

250

Enrollment

Locations

Arms

53.9

Anticipated Duration (Months)

83.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opiate Addiction	Behavioral: Onsite treatment Behavioral: Enhanced referral Drug: Buprenorphine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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. Drug: Buprenorphine all participants will receive buprenorphine
Active Comparator: Enhanced Referral In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment	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

Arm

Intervention/Treatment

Experimental: 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

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.

Drug: Buprenorphine

all participants will receive buprenorphine

Active Comparator: Enhanced Referral

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment Retention [6 months]
Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation
HIV risk behaviors [6 months]
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 [6 months]
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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BOOM!Health Harm Reduction Center	Bronx	New York	United States	10451
2	Washington Heights CORNER Project	New York	New York	United States	10033
3	New York Harm Reduction Educators	New York	New York	United States	10035

Sponsors and Collaborators

Montefiore Medical Center
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Aaron Fox, MD, MS, Associate Professor of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aaron D. Fox, Associate Professor, Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT03150173

Other Study ID Numbers:

2017-7484
R01DA044878

First Posted:

May 12, 2017

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Aaron D. Fox, Associate Professor, Montefiore Medical Center

opioid use disorder, syringe exchange, HIV risk reduction

Additional relevant MeSH terms:

Opioid-Related Disorders

Buprenorphine

Study Results

No Results Posted as of Jan 18, 2022