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临床试验/NCT05845333
NCT05845333招募中不适用

Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women

The Mind Research Network1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2022年8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
334
试验地点
1
主要终点
White matter integrity during MRI scan & stimulant use

研究概览

简要总结

Substance use disorders and psychopathy are serious and costly mental health issues. Psychopathy is known to be associated with aberrant moral decision making and there is considerable interest in determining whether substance use disorders lead to impairments in these same cognitive processes. Recent large-scale research initiatives in forensic settings have begun to identify substance abuse and psychopathy-related disruption in the neural mechanisms involved in moral decision-making processes, and associations between these neural networks and future relapse and antisocial behavior. Here the investigators extend prior work (with incarcerated men) to examine these issues among incarcerated women in order to better understand sex differences. This project addresses the overall lack of neurocognitive research in criminal offenders with substance use disorders, thereby focusing on a major public health issue in an underserved and understudied population.

详细描述

There continues to be great interest and public health relevance with regard to understanding the neurobiological systems that underlie the comorbidity of substance use disorders and other psychiatric conditions. In a previous award, efforts were focused upon characterizing the neural circuitry underlying moral decision making in incarcerated men with varying levels of two frequently co-occurring conditions: stimulant abuse and psychopathy. Here this work will be extended to incarcerated women, to examine longitudinal outcomes and apply state-of-the-art network analyses for predictive models. Prior studies have demonstrated sex differences in the degree and expression of psychopathic traits, patterns of stimulant abuse, and moral decision-making. However, the neural circuitry that underlies these sex differences is not well understood. Substantial sex differences in regional gray matter volume and density in extant samples have also been identified. Collectively, sex differences in pathophysiology could have significant implications for treatment strategies and differential biomarkers of treatment prediction and outcome in men and women. The investigators will implement the research strategy with a large incarcerated population by deploying a unique mobile MRI scanner to the regional women's prison. Participants will be stratified by level of lifetime stimulant (cocaine, amphetamine) use severity and psychopathic traits (high, medium, low) and will undergo anatomical and functional MRI scanning while completing multi-modal (i.e., linguistic and picture) decision-making tasks. Results will be compared to those obtained in a prior award (incarcerated men, n>300). Functional network and dynamic network connectivity will also be examined in women using a new multiband echo planar imaging (EPI) pulse sequence, and longitudinal outcomes after release to the community will be collected to test behavioral and neuropredictive models of relapse and future antisocial behavior. This work is expected to generate a large, robust dataset that characterizes the overlapping and unique aspects of neural circuitry underlying stimulant use and psychopathy in females and males. The proposed research is in line with recent priorities emphasized by the National Institute on Drug Abuse (NIDA) for projects aimed at examining male-female differences, and effects specific to females, to improve understanding of the nature and etiology of drug abuse.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Biological sex is female
  • Intelligence Quotient 70 or higher
  • Reading level 5th grade or higher
  • Able to speak and understand English

排除标准

  • Uncorrectable auditory or visual deficits
  • Currently pregnant
  • MRI contraindication
  • Central nervous system disease
  • Current major medical condition
  • Hypertension with complications (e.g., stroke)
  • Diabetes with complications
  • Lifetime history of psychotic disorder
  • Self-report of psychotic disorder (with psychiatric hospitalization) in first degree relative
  • Drug use in past three months
  • (Healthy controls only):
  • History of arrest
  • Substance use beyond light alcohol or marijuana use
  • Currently taking psychotropic medications

结局指标

主要结局

White matter integrity during MRI scan & stimulant use

时间窗: During MRI procedure

White matter integrity (using relevant MRI analysis platforms - Functional Magnetic Resonance Imaging of the Brain software library (FSL)) correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Gray matter volume during MRI scan & stimulant use

时间窗: During MRI procedure

Gray matter volume (using relevant MRI analysis platforms - Statistical Parametric Mapping/SPM) correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional brain response during MRI scan & stimulant use during simple linguistic decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional connectivity during MRI scan & stimulant use during simple linguistic decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional brain response during MRI scan & stimulant use during simple picture decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional connectivity during MRI scan & stimulant use during moral linguistic decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Gray matter volume during MRI scan & psychopathic traits

时间窗: During MRI procedure

Gray matter volume (using relevant MRI analysis platforms - Statistical Parametric Mapping/SPM) correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional brain response during MRI scan & stimulant use during moral linguistic decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

White matter integrity during MRI scan & psychopathic traits

时间窗: During MRI procedure

White matter integrity (using relevant MRI analysis platforms - Functional Magnetic Resonance Imaging of the Brain software library (FSL)) correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional brain response during MRI scan & stimulant use during moral picture decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional connectivity during MRI scan & stimulant use during simple picture decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional brain response during MRI scan & psychopathic traits during simple linguistic decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional connectivity during MRI scan & stimulant use during moral picture decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index)

Functional brain response during MRI scan & psychopathic traits during simple picture decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional connectivity during MRI scan & psychopathic traits during simple linguistic decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional connectivity during MRI scan & psychopathic traits during simple picture decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT)) during Simple Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional connectivity during MRI scan & psychopathic traits during moral linguistic decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional brain response during MRI scan & psychopathic traits during moral linguistic decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional brain response during MRI scan & psychopathic traits during moral picture decision task

时间窗: During MRI procedure

Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Functional connectivity during MRI scan & psychopathic traits during moral picture decision task

时间窗: During MRI procedure

Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

Return to/change in antisocial behavior post-release

时间窗: Every 3 months post release for duration of grant (5 years)

Return to antisocial behavior (assessed via self report and/or official records) post-release from incarceration

Relapse to/change in stimulant use post-release

时间窗: Every 3 months post release for duration of grant (5 years)

Return to stimulant use (assessed using timeline follow back calendar (TLFB)) post-release from incarceration

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

Kent Kiehl

Professor of Psychology, Neuroscience and Law, Executive Science Officer

The Mind Research Network

研究点 (1)

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