Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02108080|
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : February 15, 2019
- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA.
- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.
- Adults age 18 and older.
- Participants will visit the NIH Clinical Center once during the study.
- Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview.
- Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder.
- Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner.
- MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.
|Condition or disease|
|Alcohol Dependence Alcohol Drinking Alcohol-Related Disorders Alcoholism Brain Mapping|
Objective: The purpose of this protocol is to obtain a standard set of assessments, including brain behavioral, structural, functional, and connectivity (structural and functional) information, on all NIAAA research participants, referred to hereinafter as Characterization Imaging Instruments (CII); a) to determine how individual differences in brain structure and evoked responses relate to generalized trait personality and behavior differences (as assessed by psychometric questionnaire instruments and behavioral measures); and b) to determine whether these individual differences relate specifically to genetic polymorphisms in genes governing neurotransmitter activity. Thus, our goal of the CII is to identify the brain structural, functional, behavioral, genetic, and other phenotypic factors that are associated with alcoholism.
Study population: Non-treatment seeking adult volunteers and inpatient participants with alcohol dependence (ADs). Inpatient ADs refer to individuals diagnosed as alcohol dependent through DSM-IV-RT criteria or at least Moderate Alcohol Use Disorder as determined by DSM-5.
Design: This study will require one visit that will include an MRI scan (if the participant is determined to be eligible for the scanner) consisting of a whole brain structural MRI, Diffusion Tensor MRI, Resting State MRI (rsMRI) as well as several task-based functional MRIs, while performing computerized behavioral, motivational, and cognitive/emotional tasks. If the participant does not qualify for the MR scans, he/she will perform only the computerized behavioral, motivational, and cognitive/emotional tasks outside the scanner. These instruments include instruments in common with a similar protocol at NIDA.
Outcome measures: The outcome measures are differences in behavioral responses using standard statistical methods, in brain structural data using AFNI, FSL, SPM and FreeSurfer software, and in blood oxygenation level dependent (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI and FSL software. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Characterization Imaging Instruments in Alcoholics and Non-Alcoholics|
|Study Start Date :||April 8, 2014|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- The purpose of this protocol is to obtain a standard set of assessments, including brain behavioral, structural, functional, and connectivity (structural and functional) information, on all NIAAA research participants, referred to hereinafter as... [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108080
|Contact: Reza Momenan, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Reza Momenan, Ph.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|