Houston Emergency Opioid Engagement System

NCT03396276 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: HSC-SBMI-17-1021
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Patient enrollment in outpatient treatment

  at the time of enrollment in outpatient treatment

• Patient retention in outpatient treatment

  30 days after induction in the emergency department

Study Arms (1)

Suboxone induction into MAT in the ED

EXPERIMENTAL

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

Drug: Suboxone; Behavioral: Brief counseling in the ED; Behavioral: Referral to outpatient treatment; Behavioral: Follow-up coaching

Interventions

Suboxone DRUG

8mg of buprenorphine/2mg of naloxone

Suboxone induction into MAT in the ED

Brief counseling in the ED BEHAVIORAL

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.

Suboxone induction into MAT in the ED

Referral to outpatient treatment BEHAVIORAL

A referral will be made to one of the affiliated MAT clinics.

Suboxone induction into MAT in the ED

Follow-up coaching BEHAVIORAL

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.

Suboxone induction into MAT in the ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English-speaking patients
• Have a known sensitivity to buprenorphine or naloxone
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• James R Langabeer, EMT, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: April 1, 2018
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)