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.
Brief Title
Onsite Buprenorphine Treatment at Syringe Exchange Programs
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Opiate Addiction
Eligibility Criteria
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)
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)
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
opioid use disorder, syringe exchange, HIV risk reduction
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03150173
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7484
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
Primary Outcomes
Outcome Description
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.
Outcome Measure
Buprenorphine Engagement
Outcome Time Frame
30 days after randomization
Secondary Ids
Secondary Id
R01DA044878
Secondary Outcomes
Outcome Description
Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation
Outcome Time Frame
6 months
Outcome Measure
Treatment Retention
Outcome 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).
Outcome Time Frame
6 months
Outcome Measure
HIV Risk Behaviors
Outcome 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.
Outcome Time Frame
6 months
Outcome Measure
Diversion
Outcome 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.
Outcome Time Frame
6 months
Outcome Measure
Incremental Cost-effectiveness Ratio (ICER)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aaron Fox
Investigator Email
adfox@montefiore.org
Investigator Phone
718-920-7173