Clinical trial NCT03968237: Measures to Improve Outcomes After an Opioid Overdose
Official title: Measures to Improve Outcomes After an Opioid Overdose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Overdose
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Emergency Room Department

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* 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:

* Non-opioid substance overdose or overdose that does not respond to naloxone
* 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

Primary outcomes:
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: at screening
measure: Opioid Related Emergency Department (ED) Visits
timeFrame: up to 30 days
measure: Treatment Engagement
timeFrame: up to 6 months
Secondary outcomes:
measure: Demographic Data
timeFrame: at screening
measure: Brief Addiction Monitor (BAM)
timeFrame: up to 6 months
measure: Urine Drug Screen
timeFrame: up to 6 months
measure: HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Center for Leading Edge Addiction Research
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nassima Ait-Daoud Tiouririne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: