NCT04811014

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
51mo left

Started Apr 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Apr 2021Aug 2030

First Submitted

Initial submission to the registry

March 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

9.4 years

First QC Date

March 17, 2021

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient retention in treatment

    Percentage of enrolled youth in treatment over time

    30 days after enrollment

  • Patient abstinence from opioids

    Days without substance use

    30 days after enrollment

Secondary Outcomes (1)

  • Frequency of opioid emergencies among adolescents in Houston, Texas

    Through study completion, an average of 3 years

Study Arms (1)

MOUD induction and behavioral interventions among opioid-dependent youths

EXPERIMENTAL

Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions

Drug: Buprenorphine, Naloxone Drug CombinationBehavioral: Individual CounselingBehavioral: Peer Recovery Support ServicesBehavioral: Support GroupBehavioral: Referral to Medication ManagementBehavioral: Assertive Outreach

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

Also known as: Suboxone
MOUD induction and behavioral interventions among opioid-dependent youths

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

Also known as: Therapy
MOUD induction and behavioral interventions among opioid-dependent youths

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
MOUD induction and behavioral interventions among opioid-dependent youths
Support GroupBEHAVIORAL

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

Also known as: Group Therapy
MOUD induction and behavioral interventions among opioid-dependent youths

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

MOUD induction and behavioral interventions among opioid-dependent youths

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
MOUD induction and behavioral interventions among opioid-dependent youths

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Non-English-speaking patients
  • Have a known sensitivity to buprenorphine or naloxone
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersOpiate OverdoseSubstance-Related Disorders

Interventions

Buprenorphine, Naloxone Drug CombinationTherapeuticsSelf-Help GroupsPsychotherapy, GroupCommunity-Institutional Relations

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersDrug OverdosePrescription Drug MisuseDrug Misuse

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsOrganizationsHealth Care Economics and OrganizationsSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesPublic RelationsOrganization and AdministrationHealth Services Administration

Study Officials

  • James R Langabeer, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James R Langabeer, PhD

CONTACT

Meredith M O'Neal, MA

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 23, 2021

Study Start

April 19, 2021

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2030

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations