Young Houston Emergency Opioid Engagement System (YHEROES)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

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

Treatments: Behavioral: Assertive Outreach; Drug: Buprenorphine, Naloxone Drug Combination; Behavioral: Peer Recovery Support Services; Behavioral: Support Group; Behavioral: Individual Counseling; Behavioral: Referral to Medication Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04811014

HSC-MS-20-1376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental group

Description:

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

Treatment:

Behavioral: Referral to Medication Management

Behavioral: Individual Counseling

Behavioral: Support Group

Behavioral: Peer Recovery Support Services

Drug: Buprenorphine, Naloxone Drug Combination

Behavioral: Assertive Outreach