Effect of Functional Genetic Polymorphisms on Brain Morphology and Function
|First Received Date ICMJE||December 18, 2009|
|Last Updated Date||October 23, 2014|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To understand the relationship between genetic polymorphisms and brain morphology and their association to brain function and behavior.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01035723 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Functional Genetic Polymorphisms on Brain Morphology and Function|
|Official Title ICMJE||Effect of Functional Genetic Polymorphisms on Brain Morphology|
- New research on genetics and the human genome has helped to identify certain genes that affect specific parts of the brain, including the parts that may be involved in drug use and dependency. Researchers are interested in studying both genetic information and brain activity to better understand variations in brain function among individuals.
- To study brain activity in conjunction with specific genetic information provided by healthy volunteers including smokers, non-smokers, people with drug dependence, and those who do not have any dependence on any substance.
- Healthy volunteers between 18 and 50 years of age.
Functional genetic polymorphisms have been identified that influence the morphology and function of brain regions that have been implicated in addictive and neuropsychiatric disorders. This protocol aims to integrate genotyping with both structural and functional brain imaging to investigate the impact of specific functional polymorphisms on morphology and function of the amygdala and the hippocampus and on behavior mediated by these brain regions. Functional polymorphisms of the BDNF, SLC6A4, and DISC1 genes will be studied, as these are logical candidates to influence variability in brain morphology and function. The overall hypothesis is that variation in morphology and function of the amygdala and the hippocampus is explained, at least in part, by specific genotype differences.
The study population will consist of healthy male and female adult volunteers (18-50 years old).
After being medically cleared and giving written informed consent, each participant will undergo a structural MRI scan of the brain to be used for volumetric measurements of the amygdala, hippocampus, prefrontal cortex, and intracranial cavity. Each participant will undergo an fMRI scanning session, which will include an emotional context memory task specifically designed to require functioning of the amygdala and the hippocampus. A venous blood sample will be collected for genotyping of BDNF, SLC6A4, and DISC1 polymorphisms. Additionally, other functional polymorphisms that may influence brain structure may also be evaluated, in exploratory fashion. If participants have already had a blood sample collected for the genetics portion of another Neuroimaging Research Branch study, they may not need to have another sample taken.
This protocol will provide no direct benefits to research participants. Understanding the relationship between genetic polymorphisms and brain morphology and their association to brain function and behavior may provide further clues to the neurobiological mechanisms underlying addictive and neuropsychiatric disorders. The potential risks are related to acquiring MRI scans in general. Medical supervision will be provided throughout the study.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Drug Abuse|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||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||600|
|Completion Date||February 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for this study, subjects must:
Subjects will be excluded if they:
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|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||NCT01035723|
|Other Study ID Numbers ICMJE||999905406, 05-DA-N406|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP