NCT05845333

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2022May 2027

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

April 7, 2023

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (22)

  • Gray matter volume during MRI scan & stimulant use

    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)

    During MRI procedure

  • White matter integrity during MRI scan & stimulant use

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

  • Gray matter volume during MRI scan & psychopathic traits

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

    During MRI procedure

  • White matter integrity during MRI scan & psychopathic traits

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

    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)

    During MRI procedure

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

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

    During MRI procedure

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

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

    During MRI procedure

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

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

    During MRI procedure

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

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

    During MRI procedure

  • Relapse to/change in stimulant use post-release

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

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

  • Return to/change in antisocial behavior post-release

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

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

Study Arms (7)

Stimulant Use Severity High

Other: Decision task

Stimulant Use Severity Medium

Other: Decision task

Stimulant Use Severity Low

Other: Decision task

Psychopathic Traits High

Other: Decision task

Psychopathic Traits Medium

Other: Decision task

Psychopathic Traits Low

Other: Decision task

Community (Healthy) Controls

Other: Decision task

Interventions

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

Community (Healthy) ControlsPsychopathic Traits HighPsychopathic Traits LowPsychopathic Traits MediumStimulant Use Severity HighStimulant Use Severity LowStimulant Use Severity Medium

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Incarcerated and non-incarcerated adult women

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

RECRUITING

MeSH Terms

Conditions

Criminal Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Carla Harenski

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology, Neuroscience and Law, Executive Science Officer

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 6, 2023

Study Start

August 1, 2022

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations