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临床试验/NCT04811014
NCT04811014招募中4 期

Houston Emergency Engagement System for Youths and Adolescents

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年4月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
250
试验地点
1
主要终点
Patient abstinence from opioids

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Buprenorphine, Naloxone Drug Combination (Drug)

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Individual Counseling (Behavioral)

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Peer Recovery Support Services (Behavioral)

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Support Group (Behavioral)

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Referral to Medication Management (Behavioral)

MOUD induction and behavioral interventions among opioid-dependent youths

Experimental

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

干预措施: Assertive Outreach (Behavioral)

结局指标

主要结局

Patient abstinence from opioids

时间窗: 30 days after enrollment

Days without substance use

Patient retention in treatment

时间窗: 30 days after enrollment

Percentage of enrolled youth in treatment over time

次要结局

  • Frequency of opioid emergencies among adolescents in Houston, Texas(Through study completion, an average of 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Langabeer

Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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