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Objective: The primary objective of the current study is to implement a distress tolerance assessment for use in fMRI to determine the neurobiological differences between individuals with low and high distress tolerance. Additionally, other biological and physiological indicators will be assessed, including genetic polymorphisms, salivary cortisol, galvanic skin response, and blood pressure. The overall hypothesis is that individuals with low distress tolerance will exhibit hyperactivation in the extended amygdala and hypoactivation of the prefrontal cortex and anterior cingulate cortex when experiencing affective distress and failure during a stressful task, as compared to individuals with high distress tolerance.
Study Population: The study population will consist of healthy male and female adult volunteers (18-55 years old), as well as an otherwise healthy sample of male and female treatment seeking substance users with cocaine users (18-55 years old) (see exclusion criteria).
Experimental Design and Methods: After being medically cleared and giving written informed consent, each participant will undergo a structural MRI scan of the brain, and undergo an fMRI scanning session, which will include administration of the distress tolerance and relevant control tasks. Physiological response to the tasks, including heart rate, blood pressure, galvanic skin conductance, and salivary cortisol concentrations will be monitored throughout the fMRI scan. Follow-up assessments on control and cocaine dependent participants will occur at 1, 3, 6, and 12 months after the baseline assessment. Genetic data collected under the aegis of protocol 10-DA-N457 will be compared with data collected under this study.
Outcome Measures: Outcome measures include distress tolerance measured as latency in seconds to task termination on each of the distress tolerance tasks, neural indices of distress tolerance (for all participants), and substance use treatment outcomes (for cocaine users) including relapse to drug use, latency to first cocaine use, and number of substance use days per week at follow-ups.
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Inclusion and exclusion criteria
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing age before each experimental session.
Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
Have current major psychiatric disorders to include, but not limited to, mood, anxiety, borderline personality disorder, psychotic disorders, or substance-induced psychiatric disorders,
Have neurological illnesses including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
Control participants: Meet DSM-IV criteria for any past or current substance abuse or dependence; use of illicit substances in the last 30 days or nicotine if use is greater than 10 cigarettes per day and/or Fagerstrom score is greater than 3.
Cocaine using participants:
Regular use of any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling. Medications that could interfere with the BOLD signal include compounds that have been shown to be vasoactive, including alpha agonists, beta blockers, and calcium channel blockers.
Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above).
Acute drug intoxication or positive urine drug screen at the beginning of the study
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Data sourced from clinicaltrials.gov
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