Young Houston Emergency Opioid Engagement System

Официальное название

Houston Emergency Engagement System for Youths and Adolescents

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Поведенческое Individual Counseling
  One-on-one counseling with a licensed chemical dependency counselor
• Поведенческое Peer Recovery Support Services
  24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
• Поведенческое Support Group
  Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
• Поведенческое Referral to Medication Management
  Study staff will refer patients to long-term MOUD providers in the community
• Поведенческое 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.

Первичные конечные точки

• Patient retention in treatment [Срок оценки: 30 days after enrollment]
• Patient abstinence from opioids [Срок оценки: 30 days after enrollment]

Вторичные конечные точки (1)

• Frequency of opioid emergencies among adolescents in Houston, Texas [Срок оценки: Through study completion, an average of 3 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT04811014 · HSC-MS-20-1376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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