Houston Emergency Opioid Engagement System

Phase 4

• Conditions: Opioid Use Disorder
• Interventions: Drug: Suboxone; Behavioral: Brief counseling in the ED; Behavioral: Referral to outpatient treatment; Behavioral: Follow-up coaching

• Registration Number: NCT03396276
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-10
• Study Start: 2018-04-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suboxone induction into MAT in the ED	Suboxone	Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Suboxone induction into MAT in the ED	Brief counseling in the ED	Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Suboxone induction into MAT in the ED	Referral to outpatient treatment	Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Suboxone induction into MAT in the ED	Follow-up coaching	Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States