Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2019-08-01
2021-06-30
Brief Summary
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Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.
Detailed Description
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OBOT Follow-up The patient's follow-up care will take place at the OBOT clinic, supervised by an Addiction Medicine specialist (physician) with a buprenorphine-waiver and an license clinical social worker (LCSW). Scheduling of all OBOT visits during this study are in alignment with the OBOT standard of care, including frequency and duration of visits. A total of 10 visits will be scheduled over the course of 6 months.
Month 1:
Visit 1:
The first OBOT visit will last approximately 60 minutes and will entail the following:
A standard initial evaluation, urine drug screen, urine pregnancy test, method of contraception, administration of the Brief Addiction Monitor (BAM), HIV-Risk Taking Behavior Scale, discussion of treatment plan and goals, and buprenorphine/naloxone prescription from physician.
Visits 2 through 4:
Each visit will last between 16 minutes to 1 hour. During each visit, the following tasks will be accomplished:
The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, and buprenorphine/naloxone prescription from physician.
Month 2:
Visits 5 and 6:
Each visit will last between16 minutes to 1 hour. During each visit, the following tasks will be accomplished:
The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, administration of BAM and HIV-Risk Taking Scale once (either of Visit 5 or 6), HIV-Risk Taking Behavior Scale and buprenorphine/naloxone prescription from physician.
Months 3 to 6:
Visits 7 through 10:
Each visit will last between 16 minutes to 1 hour. During each visit, the following tasks will be accomplished:
The subject will be asked about their drug use, urine drug screen, urine pregnancy test, method of contraception, discussion of treatment progress and adherence to plan and goals, therapy, administration of BAM and HIV-Risk Taking Scale, and buprenorphine/naloxone prescription from physician.
Conditions
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Study Design
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OTHER
OTHER
Interventions
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Buprenorphine/Naloxone
Controlled substances
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Person can read, write, and speak in English.
* Presenting to the University of Virginia ED with opioid overdose and administration of naloxone either by EMS or in the ED.
* Experiencing some withdrawal symptoms (COWS score of 12 or higher) or experiencing 3 of the following symptoms: tremor/twitching, irritability, joint or bone aches, bad chills or sweating, goose bumps
* Express an interest in receiving a buprenorphine/naloxone induction with the goal to continue the same treatment outpatient
Exclusion Criteria
* Patients requiring admission secondary to medical or psychiatric complications
* Patients on prescribed methadone
* Women who are pregnant; This medication may precipitate opioid withdrawal in pregnant patients with opioid use disorder. Withdrawal can harm the placenta function, preterm labor, fetal convulsions (seizures), stunted fetal growth and fetal death during pregnancy.
* Mothers who are breastfeeding
* Persons under the age of 18
* Persons not able to attend follow-up clinic visits
* Persons not able to consent
* Known allergy or sensitivity to buprenorphine
18 Years
ALL
No
Sponsors
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Nassima Ait-Daoud Tiouririne
OTHER
Responsible Party
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Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Leading Edge Addiction Research
Principal Investigators
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Nassima Ait-Daoud Tiouririne, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21455
Identifier Type: -
Identifier Source: org_study_id