Onsite Buprenorphine Treatment at Syringe Exchange Programs

Opiate Addiction Clinical Trial

— O-BMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150173
• Other study ID #: 2017-7484
• Secondary ID: R01DA044878
• Status: Completed
• Phase: Phase 2
• Start date: January 2, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 31, 2024
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opiate Addiction
• Opioid-Related Disorders

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	BOOM!Health Harm Reduction Center	Bronx	New York
United States	New York Harm Reduction Educators	New York	New York
United States	Washington Heights CORNER Project	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buprenorphine Engagement	Having an active buprenorphine prescription at 30 days after randomization	30 days
Secondary	Treatment Retention	Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	6 months