Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorThe Mind Research Network
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Biological sex is female
Intelligence Quotient 70 or higher
Reading level 5th grade or higher
Able to speak and understand English
Disqualifiers
Uncorrectable auditory or visual deficits
Currently pregnant
MRI contraindication
Central nervous system disease
Trial population
Incarcerated and non-incarcerated adult women
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Decision task
Other interventionParticipants will complete a simple and/or moral decision making functional MRI task.
Treatment groups
334 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Stimulant Use Severity High1 intervention
Group B: Stimulant Use Severity Medium1 intervention
Group C: Stimulant Use Severity Low1 intervention
Group D: Psychopathic Traits High1 intervention
Group E: Psychopathic Traits Medium1 intervention
Group F: Psychopathic Traits Low1 intervention
Group G: Community (Healthy) Controls1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
During MRI procedure2
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)
Time frame
During MRI procedure3
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)
Time frame
During MRI procedure4
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)
Time frame
During MRI procedureSponsors and contacts
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Source ClinicalTrials.gov