Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Stimulant Use
研究概览
简要总结
This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. A variety of assessments and tasks including Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), blood draws, urine drug screens, and both self-report and clinician-rated assessments will be used to assess biomarkers in this population. This study has a visit schedule of four in-person visits and eight remote visits per year.
详细描述
This project is a five-year observational study that will use a variety of assessments and tasks to phenotype participants with lifetime or current Stimulant Use Disorder as well as healthy control individuals. The data collection will include collecting urine samples for diagnostic tracking, socio-demographic and lifestyle factors, clinical and behavioral assessments, blood-based biomarkers, genomics, cell-based assays, EEG, and MRI to establish phenotypic biosignature subtypes over the longitudinal timeline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be an adult between the ages of 18-85, inclusive.
- •Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
- •For participants with current/history of Stimulant Use Disorder: Subjects must meet MINI International Neuropsychiatric Inventory (MINI) criteria for current stimulant use disorder or meet MINI supplemental criterial for lifetime stimulant use disorder. For Healthy control individuals: Subjects must meet criteria for a healthy control: No history of substance use disorder or other mental illness as defined by the MINI International Neuropsychiatric Inventory (MINI).
- •Be willing to provide consent and comply with all procedure instructions.
- •Be willing to provide blood samples and participate in EEGs and MRIs.
排除标准
- •For participants with stimulus use disorder cohort: Have a history of schizophrenia, schizoaffective disorders, or chronic psychotic disorders based on the MINI. For healthy control individuals: Have a history of substance use disorder or any other psychiatric disorder as defined by the MINI and supplemental questions.
- •Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
- •Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
结局指标
主要结局
Stimulant Use
时间窗: 5 years
The primary outcome measure is maintaining a naturalistic database of stimulant use disorders using urine drug screens and self-reported use through the Timeline follow-back questionnaires.
次要结局
- Longitudinal changes from baseline in symptoms of mania assessed by the Altman Self-Rating Mania scale (ASRM).(5 years)
- Longitudinal changes from baseline on proteomic, metabolomic, transcriptomic, and epigenomic factors assessed using fluid-based biomarkers(5 years)
- Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)(5 years)
- Longitudinal changes from baseline Electroencephalogram (EEG) metrics(Baseline and every three months for five years)
- Longitudinal changes from baseline sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)(5 years)
- Demographic Differences in Stimulant Use(5 years)
- Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale(5 years)
- Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)(5 years)
- Longitudinal changes from baseline in quality of life assessed by the Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)(5 years)
- Longitudinal changes from baseline Magnetic Resonance Imaging (MRI) metrics(Baseline and every six months for five years)
研究者
Madhukar H. Trivedi, MD
Professor
University of Texas Southwestern Medical Center