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Houston Emergency Opioid Engagement System (HEROES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03396276
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
James Langabeer, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: Suboxone Behavioral: Brief counseling in the ED Behavioral: Referral to outpatient treatment Behavioral: Follow-up coaching Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Houston Emergency Opioid Engagement System (HEROES)
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Suboxone induction into MAT in the ED
Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient enrollment in outpatient treatment [ Time Frame: at the time of enrollment in outpatient treatment ]
  2. Patient retention in outpatient treatment [ Time Frame: 30 days after induction in the emergency department ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396276


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

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: James R Langabeer, EMT, PhD    713-500-3925    James.R.Langabeer@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: James R Langabeer, EMT, PhD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: James Langabeer, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03396276    
Other Study ID Numbers: HSC-SBMI-17-1021
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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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
Additional relevant MeSH terms:
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Emergencies
Opioid-Related Disorders
Disease Attributes
Pathologic Processes
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists