Measures to Improve Outcomes After an Opioid Overdose

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.

Study Overview

• Status: Unknown
• Conditions: Opioid Overdose
• Intervention / Treatment: Drug: Buprenorphine/Naloxone

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Eva Jenkins-Mendoza; Phone Number: (434)243-0562; Email: emj9c@virginia.edu
• Study Contact Backup: Name: Tracie Kostelac; Phone Number: (434)243-0563; Email: tlk5d@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • UVA Center for Leading Edge Addiction Research
      • Contact: Tracie Kostelac; Phone Number: (434)243-0563; Email: tlk5d@virginia.edu
      • Contact: Eva Jenkins-Mendoza; Phone Number: 434-243-0562; Email: emj9c@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from Emergency Room Department

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Opiate Withdrawal Scale (COWS)	The COWS is an 11 item scale designed to be administered by a clinican. This tool is used to rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. Reduction in adverse events will be evaluated by the documentation of COWS scores right after administration of Naloxone, then buprenorphine/naloxone.	at screening
Opioid Related Emergency Department (ED) Visits	Reduce risk of opioid re-overdose following ED buprenorphine/naloxone induction protocol. This will be measured by calculating the percentage of opioid related visits to any ED at 7 days post discharge, at 30 days post discharge, and hospital admissions at 30 days discharge.	up to 30 days
Treatment Engagement	Improve addiction treatment engagement for patients receiving ED buprenorphine/naloxone induction following opioid overdose. This will be measured by the number of ED patients scheduled for follow-up at the office based opioid treatment (OBOT) clinic versus number of patients that attend the scheduled first appointment and number of patients that continue to follow-up at the OBOT clinic at 30 days and at 6 months.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Data	The investigator will collect the demographic data of the population served by this protocol.	at screening
Brief Addiction Monitor (BAM)	Report of substance use and social and health outcomes. It is a 17 item, multidimensional questionnaire which assess three substance use disorder related aspects (risk factors for substance use, protective factors that support sobriety, and drug and alcohol use).	up to 6 months
Urine Drug Screen	Percentage of urine toxicology positive for illicit drug and opioid use.	up to 6 months
HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale	Social and Health Outcomes. It is an 11 item validated scale for drug use and sexual behavior.	up to 6 months

Collaborators and Investigators

• Sponsor: Nassima Ait-Daoud Tiouririne

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: 21455 (University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No