- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396276
Houston Emergency Opioid Engagement System (HEROES)
September 26, 2025 updated by: James Langabeer, The University of Texas Health Science Center, Houston
Houston Emergency Opioid Engagement System (HEROES)
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.
Study Overview
Status
Enrolling by invitation
Conditions
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 Type
Interventional
Enrollment (Estimated)
3000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Suboxone induction into MAT in the ED
Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
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8mg of buprenorphine/2mg of naloxone
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.
A referral will be made to one of the affiliated MAT clinics.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient enrollment in outpatient treatment
Time Frame: at the time of enrollment in outpatient treatment
|
at the time of enrollment in outpatient treatment
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Patient retention in outpatient treatment
Time Frame: 30 days after induction in the emergency department
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30 days after induction in the emergency department
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James R Langabeer, EMT, PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
August 31, 2030
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 9, 2018
First Posted (Actual)
January 10, 2018
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 26, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Narcotic-Related Disorders
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Opioid-Related Disorders
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Pharmaceutical Preparations
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Heterocyclic Compounds, 4 or More Rings
- Drug Combinations
- Naloxone
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Buprenorphine
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- HSC-SBMI-17-1021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not sharing IPD
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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