YHEROES: Young Houston Emergency Opioid Engagement System

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04811014
Collaborator
(none)
15
1
1
59.4
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Buprenorphine, Naloxone Drug Combination
  • Behavioral: Individual Counseling
  • Behavioral: Peer Recovery Support Services
  • Behavioral: Support Group
  • Behavioral: Referral to Medication Management
  • Behavioral: Assertive Outreach
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Houston Emergency Engagement System for Youths and Adolescents
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Patient retention in treatment [30 days after enrollment]

      Percentage of enrolled youth in treatment over time

    2. Patient abstinence from opioids [30 days after enrollment]

      Days without substance use

    Secondary Outcome Measures

    1. Frequency of opioid emergencies among adolescents in Houston, Texas [Through study completion, an average of 3 years]

      Prevalence of opioid overdoses among youth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Langabeer, Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT04811014
    Other Study ID Numbers:
    • HSC-MS-20-1376
    First Posted:
    Mar 23, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022