Houston Emergency Opioid Engagement System (HEROES)

• ClinicalTrials.gov Identifier: NCT03396276
• Recruitment Status: Recruiting
• First Posted: January 10, 2018
• Last Update Posted: May 18, 2022
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): James Langabeer, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: January 4, 2018
• First Posted Date: January 10, 2018
• Last Update Posted Date: May 18, 2022
• Actual Study Start Date: April 1, 2018
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2018)

• Patient enrollment in outpatient treatment [ Time Frame: at the time of enrollment in outpatient treatment ]
• Patient retention in outpatient treatment [ Time Frame: 30 days after induction in the emergency department ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Houston Emergency Opioid Engagement System
• Official Title: Houston Emergency Opioid Engagement System (HEROES)
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Opioid Dependence

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

Study Arms

Experimental: Suboxone induction into MAT in the ED

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

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 7, 2019): 250
• Original Estimated Enrollment (submitted: January 9, 2018): 50
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: James R Langabeer, EMT, PhD; 713-500-3925; James.R.Langabeer@uth.tmc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03396276
• Other Study ID Numbers: HSC-SBMI-17-1021
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: James Langabeer, The University of Texas Health Science Center, Houston
• Original Responsible Party: James R Langabeer, The University of Texas Health Science Center, Houston, Professor
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: James R Langabeer, EMT, PhD; The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: May 2022