Measuring Distress Tolerance With Functional MRI
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      Background:

      - People who are in treatment for substance abuse often feel distress during the withdrawal
      period and afterward. Some individuals feel distress more acutely than others, and this
      distress has been linked to poor treatment outcomes and increased risk of relapse in smokers,
      alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the
      effects of distress on the brain, particularly in individuals who are seeking treatment for
      substance abuse. Researchers are interested in using functional magnetic resonance imaging
      (fMRI) scanning to study distress tolerance in both substance users seeking treatment and
      healthy non-drug-using volunteers.

      Objectives:

      - To use functional magnetic resonance imaging to study the effectiveness of a distress
      tolerance assessment.

      Eligibility:

      - Individuals between 18 and 50 years of age who are either cocaine dependent or healthy
      non-drug-using volunteers.

      Design:

        -  This study involves an initial screening visit and a scanning visit, with four followup
           visits.

        -  Participants will be screened with a medical history and physical examination, as well
           as blood samples and questionnaires about mood and past and current drug use.

        -  Participants will have a structural MRI scan of the brain to provide a baseline reading
           for comparison. Participants will then have an fMRI scanning session, which will include
           both the distress tolerance assessment and relevant control tasks. Heart rate, blood
           pressure, and other physical reactions will be monitored throughout the scan.
           Participants will also provide blood and saliva samples to measure stress hormone
           levels.

        -  Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6,
           and 12 months after the scanning visit.
    

Detailed description: 
      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.
    

Time perspective: Other
Keywords: Distress Tolerance; Cocaine Dependence; Relapse; Limbic System; Prefrontal Cortex; Healthy Volunteer; HV