Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    1000
  • sponsor
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Updated on 30 July 2021
alcoholism
alcohol use disorder

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.

Description

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 in blood oxygenation level dependent (BOLD) signal measured using standard techniques and analyzed using established image analysis approaches and software tools such as AFNI, SPM, FSL, DTI, Studio, etc. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols.

Details
Condition Drug abuse, Alcohol use, Alcohol-Related Disorders, Brain Mapping, Alcohol abuse, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Alcohol Use Disorder, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Substance Abuse, Drug use, Alcohol Dependence, alcohol related disorders, alcoholism, alcohol dependence syndrome, chronic alcoholism
Clinical Study IdentifierNCT02108080
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last Modified on30 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All adult participants must be
Age 18 years or older
Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any
NIAAA study (including 14-AA-0181)

Exclusion Criteria

As this is a natural history protocol, there are no exclusionary criteria for
Exclusion criteria for MR scan
this study
Participants should have been tested negative at the time of consent and study
procedures using an alcohol breathalyzer, Individuals with a positive breath
Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner
alcohol concentration (BrAC) will be re-scheduled or withdrawn from the study
Are left-handed
session. On the study session day, the following exclusion criteria will be
applied
Upon completion of the consent, the participant will be invited for the study
Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, opiates and tetrahydrocannabinol (THC) for outpatients. Positive UDT for benzodiazepines and THC are not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes
Task performance (behavioral, fMRI) only: cleared based on neuromotor examination
Positive BrAC#
Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner
Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score >= 8
Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data
Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion
Women: are pregnant#
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