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