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Stimulant AbuseNCT05845333

Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women

An observational study of Stimulant Abuse and Criminal Behavior, run by The Mind Research Network at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Stimulant Abuse, Criminal Behavior
What is being tested?
Decision task
How many people
334 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 31 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Incarcerated and non-incarcerated adult women

Who may be able to join

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

Who cannot join

  • Uncorrectable auditory or visual deficits
  • Currently pregnant
  • MRI contraindication
  • Central nervous system disease
  • Current major medical condition
  • Hypertension with complications (e.g., stroke)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carla Harenski contact

505-272-5028

charenski@mrn.org

United States1 site, 1 recruiting
  • The Mind Research Network

    Albuquerque, New Mexico, 87106

    Carla Harenski, 505-272-5028, charenski@mrn.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Decision task
Medical subject headings
Criminal Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decision taskOther

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

Study groups in NCT05845333
Study groupRoleWhat they receive
Stimulant Use Severity HighNot described
Receives: Other: Decision task
Stimulant Use Severity MediumNot described
Receives: Other: Decision task
Stimulant Use Severity LowNot described
Receives: Other: Decision task
Psychopathic Traits HighNot described
Receives: Other: Decision task
Psychopathic Traits MediumNot described
Receives: Other: Decision task
Psychopathic Traits LowNot described
Receives: Other: Decision task
Community (Healthy) ControlsNot described
Receives: Other: Decision task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: During MRI procedure

  2. 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)

    Measured: During MRI procedure

  3. 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)

    Measured: During MRI procedure

  4. 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)

    Measured: During MRI procedure

  5. 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)

    Measured: During MRI procedure

  6. 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)

    Measured: During MRI procedure

  7. 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)

    Measured: During MRI procedure

  8. 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)

    Measured: During MRI procedure

  9. 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)

    Measured: During MRI procedure

  10. 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)

    Measured: During MRI procedure

  11. 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)

    Measured: During MRI procedure

  12. 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)

    Measured: During MRI procedure

  13. 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)

    Measured: During MRI procedure

  14. 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)

    Measured: During MRI procedure

  15. 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)

    Measured: During MRI procedure

  16. 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)

    Measured: During MRI procedure

  17. 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)

    Measured: During MRI procedure

  18. 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)

    Measured: During MRI procedure

  19. 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)

    Measured: During MRI procedure

  20. 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)

    Measured: During MRI procedure

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Aug 2022
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05845333
Sponsor's protocol ID
15050
Status last verified
May 2025
First submitted
7 Apr 2023
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stimulant Abuse and Criminal Behavior, run by The Mind Research Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carla Harenski (505-272-5028, charenski@mrn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gray matter volume during MRI scan & stimulant use (time frame: During MRI procedure). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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