ClinicalTrials.gg
RecruitingNCT04811014YHEROESUpdated Oct 1, 2025

Young Houston Emergency Opioid Engagement System

A Phase 4 interventional study of Buprenorphine, Naloxone Drug Combination and Individual Counseling in Opioid-use Disorder, Opioid Dependence and Opioid Overdose, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-01.

Primary conditionOpiate OverdoseRegistry: Opioid-Related DisordersReclassifiedWhy we changed it
Registry
Opioid-Related Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Opiate Overdose
Why
  1. The study's listed conditions name Opiate Overdose, a narrower term within Opioid-Related Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Opioid-use Disorder
  • Opioid Dependence
  • Opioid Overdose
  • Opioid Use
  • Substance Use Disorders

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03

In context

Opiate Overdose Reclassified

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's planned enrollment of 250 is above the median of 184 across 48 interventional studies indexed under Opiate Overdose.

Browse Opiate Overdose studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Compared within Opiate Overdose, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 - Text Revision (DSM-IV-TR) criteria for opioid dependence
  • Patients must be able to speak English
  • Be agreeable to and capable of signing the and assent (parent or guardian must consent, minor must assent)

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • 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 · Behavioral: Individual Counseling · Behavioral: Peer Recovery Support Services · Behavioral: Support Group · Behavioral: Referral to Medication Management · Behavioral: Assertive Outreach

Interventions

  • DrugBuprenorphine, 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

    Also known as: Suboxone

  • BehavioralIndividual Counseling

    One-on-one counseling with a licensed chemical dependency counselor

    Also known as: Therapy

  • BehavioralPeer Recovery Support Services

    24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management

    Also known as: Peer Coaching, Recovery Coaching

  • BehavioralSupport Group

    Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups

    Also known as: Group Therapy

  • BehavioralReferral to Medication Management

    Study staff will refer patients to long-term MOUD providers in the community

  • BehavioralAssertive 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.

    Also known as: Community Outreach

06

What researchers measure

Primary outcomes

  1. Patient retention in treatment

    Percentage of enrolled youth in treatment over time

    Time frame: 30 days after enrollment

  2. Patient abstinence from opioids

    Days without substance use

    Time frame: 30 days after enrollment

Secondary outcomes

  1. Frequency of opioid emergencies among adolescents in Houston, Texas

    Prevalence of opioid overdoses among youth

    Time frame: Through study completion, an average of 3 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04811014
Responsible party
James Langabeer (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Mar 23, 2021
Start date
Apr 19, 2021
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Oct 1, 2025

Study contacts

James R Langabeer, PhD
Contact
james.r.langabeer@uth.tmc.edu
713-500-3925
Meredith M O'Neal, MA
Contact
meredith.m.oneal@uth.tmc.edu
713-500-3624
James R Langabeer, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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