HEROES: Houston Emergency Opioid Engagement System

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT03396276
Collaborator
(none)
250
1
1
69
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Suboxone
  • Behavioral: Brief counseling in the ED
  • Behavioral: Referral to outpatient treatment
  • Behavioral: Follow-up coaching
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Houston Emergency Opioid Engagement System (HEROES)
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Suboxone induction into MAT in the ED

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

Drug: Suboxone
8mg of buprenorphine/2mg of naloxone

Behavioral: Brief counseling in the ED
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.

Behavioral: Referral to outpatient treatment
A referral will be made to one of the affiliated MAT clinics.

Behavioral: Follow-up coaching
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.

Outcome Measures

Primary Outcome Measures

  1. Patient enrollment in outpatient treatment [at the time of enrollment in outpatient treatment]

  2. Patient retention in outpatient treatment [30 days after induction in the emergency department]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: James R Langabeer, EMT, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Langabeer, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03396276
Other Study ID Numbers:
  • HSC-SBMI-17-1021
First Posted:
Jan 10, 2018
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022