Young Houston Emergency Opioid Engagement System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Houston Emergency Engagement System for Youths and Adolescents

Conditions
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Opioid-use Disorder, Opioid Dependence, Opioid Overdose, Opioid Use, Substance Use Disorders

Intervention / Treatment
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* Drug: Buprenorphine, Naloxone Drug Combination
* Behavioral: Individual Counseling
* Behavioral: Peer Recovery Support Services
* Behavioral: Support Group
* Behavioral: Referral to Medication Management
* Behavioral: Assertive Outreach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOUD induction and behavioral interventions among opioid-dependent youths<br>Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions | Drug: Buprenorphine, Naloxone Drug Combination<br>* 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<br>* Other names: Suboxone;Behavioral: Individual Counseling<br>* One-on-one counseling with a licensed chemical dependency counselor<br>* Other names: Therapy;Behavioral: Peer Recovery Support Services<br>* 24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management<br>* Other names: Recovery Coaching;Behavioral: Support Group<br>* Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups<br>* Other names: Group Therapy;Behavioral: Referral to Medication Management<br>* Study staff will refer patients to long-term MOUD providers in the community<br>Behavioral: Assertive Outreach<br>* 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.<br>* Other names: Community Outreach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient retention in treatment | Percentage of enrolled youth in treatment over time | 30 days after enrollment | 
| Patient abstinence from opioids | Days without substance use | 30 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of opioid emergencies among adolescents in Houston, Texas | Prevalence of opioid overdoses among youth | Through study completion, an average of 3 years |