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Houston Emergency Opioid Engagement System (HEROES)

Primary Purpose

Opioid Dependence

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suboxone
Brief counseling in the ED
Referral to outpatient treatment
Follow-up coaching
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In otherwise good health based on physician assessment and medical history
  • Tests positive in urine sample for opioids
  • Patients express a willingness to stop opioid use
  • Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence
  • Patients must be able to speak English
  • Be agreeable to and capable of signing informed consent

Exclusion Criteria:

  • Non-English-speaking patients
  • Have a known sensitivity to buprenorphine or naloxone
  • Be physiologically dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.
  • Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)
  • Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
  • Be a nursing or pregnant female

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suboxone induction into MAT in the ED

Arm Description

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

Outcomes

Primary Outcome Measures

Patient enrollment in outpatient treatment
Patient retention in outpatient treatment

Secondary Outcome Measures

Full Information

First Posted
January 4, 2018
Last Updated
May 17, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03396276
Brief Title
Houston Emergency Opioid Engagement System
Acronym
HEROES
Official Title
Houston Emergency Opioid Engagement System (HEROES)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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

5. Study Description

Brief Summary
The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.
Detailed Description
The Houston Emergency Response Opioid Engagement System (HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study seeks to develop an emergency- initiated opioid system of care for individuals with prior opioid overdose and opioid use disorder. The study involves both assertive outreach on individuals who have recent overdoses within the last 72 hours, as well as individuals who are admitted to local hospital emergency departments. The study explores the effect of the combination of assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MAT treatment in the emergency department, who receive routine follow-up, are more likely to engage and be retained in a longer-term treatment program for their addiction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suboxone induction into MAT in the ED
Arm Type
Experimental
Arm Description
Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Intervention Type
Drug
Intervention Name(s)
Suboxone
Intervention Description
8mg of buprenorphine/2mg of naloxone
Intervention Type
Behavioral
Intervention Name(s)
Brief counseling in the ED
Intervention Description
Patients will receive brief counseling from ED physician prior to discharge about the options for outpatient treatment, as well as opioid dependency.Consented patients will be provided with a pamphlet from the Substance Abuse and Mental Health Services Administration called "Facts About Buprenorphine", as well as an information packet for study contact information for the opioid recovery network providers.
Intervention Type
Behavioral
Intervention Name(s)
Referral to outpatient treatment
Intervention Description
A referral will be made to one of the affiliated MAT clinics.
Intervention Type
Behavioral
Intervention Name(s)
Follow-up coaching
Intervention Description
A designated paramedic with the Houston Fire Department (called the navigator or care coordinator) will work with UTHealth to jointly follow-up on patients both telephonically and in-person. The Houston Fire Department paramedic will provide brief information sharing and assist with coordination in scheduling or registering with MAT clinics or recovery coaching.
Primary Outcome Measure Information:
Title
Patient enrollment in outpatient treatment
Time Frame
at the time of enrollment in outpatient treatment
Title
Patient retention in outpatient treatment
Time Frame
30 days after induction in the emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In otherwise good health based on physician assessment and medical history Tests positive in urine sample for opioids Patients express a willingness to stop opioid use Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence Patients must be able to speak English Be agreeable to and capable of signing informed consent Exclusion Criteria: Non-English-speaking patients Have a known sensitivity to buprenorphine or naloxone Be physiologically dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary. Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease) Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk Be a nursing or pregnant female
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James R Langabeer, EMT, PhD
Phone
713-500-3925
Email
James.R.Langabeer@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Langabeer, EMT, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James R Langabeer, EMT, PhD
Phone
713-500-3925
Email
James.R.Langabeer@uth.tmc.edu

12. IPD Sharing Statement

Learn more about this trial

Houston Emergency Opioid Engagement System

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