Onsite Buprenorphine Treatment at Syringe Exchange Programs
Status: | Recruiting |
---|---|
Conditions: | Psychiatric, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/23/2018 |
Start Date: | November 19, 2018 |
End Date: | June 30, 2022 |
Contact: | Aaron Fox, MD, MS |
Email: | adfox@montefiore.org |
Phone: | 718-920-7173 |
Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
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.
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.
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.
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.
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. moderate or 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)
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