Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03968237 |
| Other study ID # |
21455 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
June 2021 |
Study information
| Verified date |
October 2020 |
| Source |
University of Virginia |
| Contact |
Eva Jenkins-Mendoza |
| Phone |
(434)243-0562 |
| Email |
emj9c[@]virginia.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a pilot study that aims to develop good clinical practices to improve outcomes after
an opioid overdose and transition of care from the Emergency Department (ED) into an Office
Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder
(OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with
buprenorphine waiver or an interest in becoming waived at our institution to implement early
initiation of buprenorphine protocol. We hope that this change in practice will result in
better management of patients with OUD and opioid overdose, reduce relapse and improve
engagement in addiction treatment.
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.
Description:
Every patient who is seen in the ED for opioid overdose and has received naloxone either by
emergency medical services (EMS) or in the ED will be eligible to participate in this study.
When patient is alert, they will be asked if they would be interested in participating in the
study and consented when appropriate. Patients will receive a buprenorphine/naloxone
induction protocol, prior to discharge and referral to the OBOT clinic.
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.
