Menu
Recruiting NCT04811014

Young Houston Emergency Opioid Engagement System

Phase IV Interventional Opioid-use Disorder Opioid Dependence Opioid Overdose Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buprenorphine, Naloxone Drug Combination, Individual Counseling, Peer Recovery Support Services, Support Group.
Who it may be relevant to
Registry conditions: Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Houston Emergency Engagement System for Youths and Adolescents

Overview

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.

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.

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
  • Behavioral Individual Counseling
    One-on-one counseling with a licensed chemical dependency counselor
  • 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
  • Behavioral Support Group
    Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
  • 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.

Primary outcome measures

  • Patient retention in treatment [Time frame: 30 days after enrollment]
  • Patient abstinence from opioids [Time frame: 30 days after enrollment]
Secondary outcome measures (1)
  • Frequency of opioid emergencies among adolescents in Houston, Texas [Time frame: Through study completion, an average of 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT04811014 · HSC-MS-20-1376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗