跳至主要内容
临床试验/NCT06136247
NCT06136247招募中不适用

Integrating Brain, Neurocognitive, and Computational Tools in Opioid Use Disorder (OUD) to Characterize Executive Function and to Predict Clinical Outcomes.

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
192
试验地点
1
主要终点
Mental health symptoms

研究概览

简要总结

The 5-year K01 Mentored Research Scientist proposal will employ brain, neurocognitive, and computational tools (e.g., machine learning) to understand the impact of opioid-use disorder (OUD) and common co-occurring issues on executive function and clinical outcomes. There have been record numbers of fatal and non-fatal overdoses (ODs) associated with opioids (and other drugs) in the past 12-months. Improving classification and predictive capabilities to enhance treatment and prevent relapse is of the upmost importance. Deficits in neurocognition often are associated with poor treatment outcomes (e.g., more drug use, medication non-adherence), yet co-occurring issues associated with OUD (e.g., depression, anxiety, physical/sexual abuse, neglect) make it difficult to parse which contributing factors lead to worse executive function (EF) and poorer treatment outcomes. Novel brain, neurocognitive, and computational tools are needed to help determine these differences, in order to lay the foundation for better treatments. This need has shaped both the training plan and the associated research project in a 5-year K01 Mentored Research Scientist proposal, building on Dr. Regier's prior preclinical and clinical addiction neuroscience experience (focused mostly on cocaine-use disorders, cue-reactivity, subcortical networks, prior adversity, and univariate imaging techniques).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • men and women with moderate to severe opioid use disorder by Diagnostic and Statistical Manual, version 5, (DSM-V) criteria on a stable (at least one week without change) dose of oral buprenorphine-naloxone or methadone. (for OUD group)
  • Eligible participants will be between 18-60 years of age;
  • able to read at an eighth-grade level;
  • able to speak English.

排除标准

  • unable to understand or complete the tasks.
  • Certain mental health conditions, including (but not limited to) bipolar I with current manic episode, schizophrenia, and schizoaffective disorder, determined by the Principal Investigator (PI) to interfere with study participation.
  • moderate or severe substance-use disorder (for Healthy Controls)

结局指标

主要结局

Mental health symptoms

时间窗: weeks 1 through 8

Patient self report of mental health symptoms on the weekly Follow Up Survey - days per week of experiencing symptoms of depression or anxiety

Drug use

时间窗: weeks 1 through 8

Patient self report of drug use on the weekly Follow Up Survey- days per week having taken any drugs

Medication adherence

时间窗: weeks 1 through 8

Patient self report of medication-assisted treatment (MAT) adherence on the weekly Follow Up Survey - days per week having taken their MAT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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