- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05845333
Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women
March 12, 2024 updated by: Kent Kiehl, The Mind Research Network
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
334
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carla Harenski
- Phone Number: 505-272-5028
- Email: charenski@mrn.org
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Recruiting
- The Mind Research Network
-
Contact:
- Carla Harenski
- Phone Number: 505-272-5028
- Email: charenski@mrn.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Incarcerated and non-incarcerated adult women
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stimulant Use Severity High
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Stimulant Use Severity Medium
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Stimulant Use Severity Low
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Psychopathic Traits High
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Psychopathic Traits Medium
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Psychopathic Traits Low
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
Community (Healthy) Controls
|
Participants will complete a simple and/or moral decision making functional MRI task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse to/change in stimulant use post-release
Time Frame: 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
|
Every 3 months post release for duration of grant (5 years)
|
Return to/change in antisocial behavior post-release
Time Frame: 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
|
Every 3 months post release for duration of grant (5 years)
|
Gray matter volume during MRI scan & stimulant use
Time Frame: 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)
|
During MRI procedure
|
White matter integrity during MRI scan & stimulant use
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & stimulant use during simple linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & stimulant use during simple picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & stimulant use during moral linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & stimulant use during moral picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & stimulant use during simple linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & stimulant use during simple picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & stimulant use during moral linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & stimulant use during moral picture decision task
Time Frame: 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)
|
During MRI procedure
|
Gray matter volume during MRI scan & psychopathic traits
Time Frame: 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)
|
During MRI procedure
|
White matter integrity during MRI scan & psychopathic traits
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & psychopathic traits during simple linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & psychopathic traits during simple picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & psychopathic traits during moral linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional brain response during MRI scan & psychopathic traits during moral picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & psychopathic traits during simple linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & psychopathic traits during simple picture decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & psychopathic traits during moral linguistic decision task
Time Frame: 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)
|
During MRI procedure
|
Functional connectivity during MRI scan & psychopathic traits during moral picture decision task
Time Frame: 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)
|
During MRI procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
April 7, 2023
First Submitted That Met QC Criteria
April 25, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15050
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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