Houston Emergency Opioid Engagement System

NCT ID: NCT03396276

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2030-08-31

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Suboxone induction into MAT in the ED

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

Group Type: EXPERIMENTAL

Suboxone

Intervention Type: DRUG

8mg of buprenorphine/2mg of naloxone

Brief counseling in the ED

Intervention Type: 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.

Referral to outpatient treatment

Intervention Type: BEHAVIORAL

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

Follow-up coaching

Intervention Type: 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.

Interventions

Suboxone

8mg of buprenorphine/2mg of naloxone

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Referral to outpatient treatment

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

James Langabeer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James R Langabeer, EMT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-SBMI-17-1021

Identifier Type: -

Identifier Source: org_study_id