Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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
Phase
Start date July 10, 2014
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05054738 - CRP and S&A for Inpatient Veterans N/A
Completed NCT02233738 - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services N/A
Recruiting NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT00536146 - The Stress-Hormone System in Alcohol-Dependent Subjects N/A
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02939352 - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues Early Phase 1
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01389297 - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery N/A
Completed NCT00768508 - Combined Pharmacotherapies for Alcoholism Phase 3
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Completed NCT01113164 - Matching Genotypes and Serotonergic Medications for Alcoholism Phase 1
Completed NCT00127231 - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women N/A
Terminated NCT02842528 - Cognitive Vulnerability Factors in Alcohol-dependence N/A
Completed NCT00367575 - An Internet-based Intervention for Problem Drinking N/A
Completed NCT00583440 - 12-step Facilitation for the Dually Diagnosed Phase 1/Phase 2
Completed NCT00223639 - New Medications to Treat Alcohol Dependence Phase 2
Completed NCT00167687 - Prazosin Alcohol Dependence IVR Study Phase 4