Measuring Distress Tolerance With Functional MRI
|First Received Date ICMJE||December 19, 2009|
|Last Updated Date||June 30, 2017|
|Start Date ICMJE||December 4, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To identify neural indices of distress tolerance using fMRI in healthy non-drug users, and examine the relationship between these neural indices and important physiological, biological, and behavioral correlates of distress tolerance.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01038232 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To determine if neural processes associated with distress tolerance predict sustained abstinence among treatment seeking cocaine dependent participants following 1, 3, 6, and 12 months follow-up.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Measuring Distress Tolerance With Functional MRI|
|Official Title ICMJE||Measuring Distress Tolerance With Functional MRI|
- 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.
- To use functional magnetic resonance imaging to study the effectiveness of a distress tolerance assessment.
- Individuals between 18 and 50 years of age who are either cocaine dependent or healthy non-drug-using volunteers.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cocaine Dependence|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||200|
|Estimated Completion Date||March 24, 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01038232|
|Other Study ID Numbers ICMJE||999910453
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||University of Maryland|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 24, 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP