Young Houston Emergency Opioid Engagement System

Opioid Use Clinical Trial

— YHEROES  

Official title:

Houston Emergency Engagement System for Youths and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811014
• Other study ID #: HSC-MS-20-1376
• Status: Recruiting
• Phase: Phase 4
• Start date: April 19, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: James R Langabeer, PhD
• Phone: 713-500-3925
• Email: james.r.langabeer[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Opiate Overdose
• Opioid Dependence
• Opioid Overdose
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient retention in treatment	Percentage of enrolled youth in treatment over time	30 days after enrollment
Primary	Patient abstinence from opioids	Days without substance use	30 days after enrollment
Secondary	Frequency of opioid emergencies among adolescents in Houston, Texas	Prevalence of opioid overdoses among youth	Through study completion, an average of 3 years