Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04811014

Conditions

Opioid-use Disorder

Opioid Dependence

Opioid Overdose

Opioid Use

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Buprenorphine, Naloxone Drug Combination

Individual Counseling

Peer Recovery Support Services

Support Group

Referral to Medication Management

Study Details

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.

Conditions

Opioid-use Disorder

Opioid Dependence

Opioid Overdose

Opioid Use

Substance Use Disorders

Study ID

NCT04811014

Start date

Apr 19, 2021

Status verified date

Sep, 2025

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MOUD induction and behavioral interventions among opioid-dependent youths

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

Interventions

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

Individual Counseling

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

Peer Recovery Support Services

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

Support Group

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

Referral to Medication Management

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

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.

Primary outcome measure

  • Patient retention in treatment [ Time Frame: 30 days after enrollment ]
  • Patient abstinence from opioids [ Time Frame: 30 days after enrollment ]

Central Contacts and Locations

Central contacts

James R Langabeer, PhD

713-500-3925james.r.langabeer@uth.tmc.edu

Meredith M O'Neal, MA

713-500-3624meredith.m.oneal@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

James R Langabeer, PhD

713-500-3925james.r.langabeer@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-10-01.