Young Houston Emergency Opioid Engagement System

Phase 4

Recruiting

• Conditions: Opioid Overdose; Opioid Dependence; Opioid-use Disorder; Substance Use Disorders; Opioid Use
• 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

• Registration Number: NCT04811014
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

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 Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-04-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOUD induction and behavioral interventions among opioid-dependent youths	Buprenorphine, Naloxone Drug Combination	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
MOUD induction and behavioral interventions among opioid-dependent youths	Referral to Medication Management	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
MOUD induction and behavioral interventions among opioid-dependent youths	Peer Recovery Support Services	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
MOUD induction and behavioral interventions among opioid-dependent youths	Support Group	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
MOUD induction and behavioral interventions among opioid-dependent youths	Individual Counseling	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions
MOUD induction and behavioral interventions among opioid-dependent youths	Assertive Outreach	Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions

Primary Outcome Measures

Name	Time	Method
Patient abstinence from opioids	30 days after enrollment	Days without substance use
Patient retention in treatment	30 days after enrollment	Percentage of enrolled youth in treatment over time

Secondary Outcome Measures

Name	Time	Method
Frequency of opioid emergencies among adolescents in Houston, Texas	Through study completion, an average of 3 years	Prevalence of opioid overdoses among youth

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States