Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

Alcoholism Clinical Trial

Official title: Characterization Imaging Instruments for Addiction Neuroimaging Assessments

Status Recruiting

Clinical Trial Summary

Background:

• 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.

Objective:

• To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.

Eligibility:

• Adults age 18 and older.

Design:

• 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.

Clinical Trial Description

Objective

The purpose of this protocol is to obtain a standard set of imaging assessments, referred to hereinafter as Characterization Imaging Instruments for Addiction Neuroimaging Assessments (CII-ANiA), including but not limited to brain behavioral, structural, functional, and connectivity (structural and functional) information, on all NIAAA research participants: a) to determine how individual differences in brain structure and function relate to various stages of alcohol use disorder, 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-ANiA is to identify the brain (structural and functional), behavioral, genetic, and other phenotypic factors that are associated with alcoholism.

Study population

Non-treatment seeking adult volunteers and inpatient participants with alcohol use disorder (AUDs). Inpatient AUDs refer to individuals diagnosed with alcohol dependence based on DSM-IV-RT criteria or Alcohol Use Disorder as determined by DSM-5 criteria.

Design

This study will require one or more visit(s) that will include MRI scan(s) (if the participant is determined eligible) consisting of a whole brain structural MRI, Diffusion Tensor MRI, Resting State functional MRI (rs-fMRI), several task-based functional MRIs, while performing computerized motivational, cognitive, and emotional tasks.

Outcome measures

Outcome measures of interest include differences in brain structural data and in blood oxygenation level dependent (BOLD) signals collected cross-sectionally and/or longitudinally at various stages of alcohol use disorder. Imaging outcomes will be measured with standard techniques and analyzed using established image analysis approaches and software tools such as AFNI, SPM, FSL, DTI Studio, etc. In this effort, we will also utilize BOLD signals elicited by each task which have been shown to be associated with various aspects of neurocircuitries in the phases of addiction. To this end, the outcome measures of interest will include, but will not be not limited to, BOLD signals for the binge/intoxication phase in the nucleus accumbens, thalamus and dorsolateral prefrontal cortex; for the withdrawal/negative emotionality phase in the amygdala, hippocampus, and ventral striatum; and for the preoccupation/anticipation phase in the prefrontal cortex, ventral striatum, and insula. Other primary outcome measures include structural and functional connectivity in salience, default mode, and executive control networks associated with the above-mentioned addiction phases, respectively. Secondary outcome measures include comparisons of the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols. ;

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Drinking
• Alcohol-Related Disorders
• Alcoholism
• Brain Mapping

• NCT number: NCT02108080
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Beth A Lee, R.N.
• Phone: (301) 451-6964
• Email: beth.lee@nih.gov
• Status: Recruiting
• Start date: July 10, 2014
• Completion date: December 31, 2025