Young Houston Emergency Opioid Engagement System (YHEROES)

October 18, 2023 updated by: James Langabeer, The University of Texas Health Science Center, Houston

Houston Emergency Engagement System for Youths and Adolescents

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. The study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention in 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 MOUD treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • In otherwise good health based on physician assessment and medical history
  • Drug screen positive 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 the informed consent and assent (parent or guardian must consent, minor must assent)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MOUD induction and behavioral interventions among opioid-dependent youths
Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
Drug: Buprenorphine, Naloxone Drug Combination
8mg of buprenorphine/2mg of naloxone to initiate MOUD treatment and bridge, if necessary, until referral to MOUD clinic can be made for ongoing treatment
Other Names:
  • Suboxone
Behavioral: Individual Counseling
One-on-one counseling with a licensed chemical dependency counselor
Other Names:
  • Therapy
Behavioral: Peer Recovery Support Services
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Other Names:
  • Peer Coaching
  • Recovery Coaching
Behavioral: Support Group
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Other Names:
  • Group Therapy
Behavioral: Referral to Medication Management
Study staff will refer patients to long-term MOUD providers in the community
Behavioral: Assertive Outreach
The investigators will conduct weekly outreach to youths who experienced an opioid overdose and attempt to initiate treatment. Outreach is completed by a paramedic and peer coach.
Other Names:
  • Community Outreach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient retention in treatment
Time Frame: 30 days after enrollment
Percentage of enrolled youth in treatment over time
30 days after enrollment
Patient abstinence from opioids
Time Frame: 30 days after enrollment
Days without substance use
30 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of opioid emergencies among adolescents in Houston, Texas
Time Frame: Through study completion, an average of 3 years
Prevalence of opioid overdoses among youth
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-20-1376

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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