- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04811014
Young Houston Emergency Opioid Engagement System (YHEROES)
September 26, 2025 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
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)
250
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
- Name: James R Langabeer, PhD
- Phone Number: 713-500-3925
- Email: james.r.langabeer@uth.tmc.edu
Study Contact Backup
- Name: Meredith M O'Neal, MA
- Phone Number: 713-500-3624
- Email: meredith.m.oneal@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- James R Langabeer, PhD
- Phone Number: 713-500-3925
- Email: james.r.langabeer@uth.tmc.edu
-
-
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
|
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:
One-on-one counseling with a licensed chemical dependency counselor
Other Names:
24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
Other Names:
Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
Other Names:
Study staff will refer patients to long-term MOUD providers in the community
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:
|
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.
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, 2030
Study Completion (Estimated)
August 31, 2030
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 (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 26, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Narcotic-Related Disorders
- Drug Misuse
- Mental Disorders
- Chemically-Induced Disorders
- Drug Overdose
- Prescription Drug Misuse
- Opiate Overdose
- Opioid-Related Disorders
- Substance-Related Disorders
- Organization and Administration
- Health Services Administration
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Pharmaceutical Preparations
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Psychotherapy
- Behavioral Disciplines and Activities
- Organizations
- Health Care Economics and Organizations
- Heterocyclic Compounds, 4 or More Rings
- Drug Combinations
- Naloxone
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Socioenvironmental Therapy
- Buprenorphine
- Public Relations
- Buprenorphine, Naloxone Drug Combination
- Therapeutics
- Psychotherapy, Group
- Self-Help Groups
- Community-Institutional Relations
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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