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临床试验/NCT03396276
NCT03396276Enrolling By Invitation4 期

Houston Emergency Opioid Engagement System (HEROES)

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2018年4月1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
Enrolling By Invitation
入组人数
3,000
试验地点
1
主要终点
Patient enrollment in outpatient treatment

研究概览

简要总结

The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.

详细描述

The Houston Emergency Response Opioid Engagement System (HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study seeks to develop an emergency- initiated opioid system of care for individuals with prior opioid overdose and opioid use disorder. The study involves both assertive outreach on individuals who have recent overdoses within the last 72 hours, as well as individuals who are admitted to local hospital emergency departments. The study explores the effect of the combination of assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention 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 MAT treatment in the emergency department, who receive routine follow-up, are more likely to engage and be retained in a longer-term treatment program for their addiction.

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
18 Years 至 —(Adult, Older Adult)
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
  • Tests positive in urine sample 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 informed consent

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

Suboxone induction into MAT in the ED

Experimental

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

干预措施: Suboxone (Drug)

Suboxone induction into MAT in the ED

Experimental

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

干预措施: Brief counseling in the ED (Behavioral)

Suboxone induction into MAT in the ED

Experimental

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

干预措施: Referral to outpatient treatment (Behavioral)

Suboxone induction into MAT in the ED

Experimental

Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)

干预措施: Follow-up coaching (Behavioral)

结局指标

主要结局

Patient enrollment in outpatient treatment

时间窗: at the time of enrollment in outpatient treatment

Patient retention in outpatient treatment

时间窗: 30 days after induction in the emergency department

次要结局

未报告次要终点

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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