Houston Emergency Opioid Engagement System

Opioid Use Disorder Clinical Trial

— HEROES  

Official title:

Houston Emergency Opioid Engagement System (HEROES)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03396276
• Other study ID #: HSC-SBMI-17-1021
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient enrollment in outpatient treatment		at the time of enrollment in outpatient treatment
Primary	Patient retention in outpatient treatment		30 days after induction in the emergency department