Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women

Sponsor
The Mind Research Network (Other)
Overall Status
Recruiting
CT.gov ID
NCT05845333
Collaborator
(none)
334
1
58
5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Decision task

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
334 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 31, 2027
Anticipated Study Completion Date :
May 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Stimulant Use Severity High

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Stimulant Use Severity Medium

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Stimulant Use Severity Low

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Psychopathic Traits High

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Psychopathic Traits Medium

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Psychopathic Traits Low

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Community (Healthy) Controls

Other: Decision task
Participants will complete a simple and/or moral decision making functional MRI task.

Outcome Measures

Primary Outcome Measures

  1. Gray matter volume during MRI scan & stimulant use [During MRI procedure]

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

  2. White matter integrity during MRI scan & stimulant use [During MRI procedure]

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

  3. Functional brain response during MRI scan & stimulant use during simple linguistic decision task [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 association with stimulant use (assessed using a modified version of the Addiction Severity Index)

  4. Functional brain response during MRI scan & stimulant use during simple picture decision task [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 association with stimulant use (assessed using a modified version of the Addiction Severity Index)

  5. Functional brain response during MRI scan & stimulant use during moral linguistic decision task [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 association with stimulant use (assessed using a modified version of the Addiction Severity Index)

  6. Functional brain response during MRI scan & stimulant use during moral picture decision task [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 association with stimulant use (assessed using a modified version of the Addiction Severity Index)

  7. Functional connectivity during MRI scan & stimulant use during simple linguistic decision task [During MRI procedure]

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

  8. Functional connectivity during MRI scan & stimulant use during simple picture decision task [During MRI procedure]

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

  9. Functional connectivity during MRI scan & stimulant use during moral linguistic decision task [During MRI procedure]

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

  10. Functional connectivity during MRI scan & stimulant use during moral picture decision task [During MRI procedure]

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

  11. Gray matter volume during MRI scan & psychopathic traits [During MRI procedure]

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

  12. White matter integrity during MRI scan & psychopathic traits [During MRI procedure]

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

  13. Functional brain response during MRI scan & psychopathic traits during simple linguistic decision task [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 association with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

  14. Functional brain response during MRI scan & psychopathic traits during simple picture decision task [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 association with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

  15. Functional brain response during MRI scan & psychopathic traits during moral linguistic decision task [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 association with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

  16. Functional brain response during MRI scan & psychopathic traits during moral picture decision task [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 association with psychopathic traits (assessed using the Psychopathy Checklist-Revised)

  17. Functional connectivity during MRI scan & psychopathic traits during simple linguistic decision task [During MRI procedure]

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

  18. Functional connectivity during MRI scan & psychopathic traits during simple picture decision task [During MRI procedure]

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

  19. Functional connectivity during MRI scan & psychopathic traits during moral linguistic decision task [During MRI procedure]

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

  20. Functional connectivity during MRI scan & psychopathic traits during moral picture decision task [During MRI procedure]

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

  21. Relapse to/change in stimulant use post-release [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

  22. Return to/change in antisocial behavior post-release [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Biological sex is female

  • Intelligence Quotient 70 or higher

  • Reading level 5th grade or higher

  • Able to speak and understand English

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Mind Research Network Albuquerque New Mexico United States 87106

Sponsors and Collaborators

  • The Mind Research Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kent Kiehl, Professor of Psychology, Neuroscience and Law, Executive Science Officer, The Mind Research Network
ClinicalTrials.gov Identifier:
NCT05845333
Other Study ID Numbers:
  • 15050
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023