NCT02108080

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jul 2014Dec 2026

First Submitted

Initial submission to the registry

April 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2014

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 14, 2026

Status Verified

April 8, 2026

Enrollment Period

12.5 years

First QC Date

April 8, 2014

Last Update Submit

April 11, 2026

Conditions

Alcohol DependenceAlcohol DrinkingAlcohol-Related DisordersAlcoholismBrain Mapping

Keywords

AlcoholBiomarkersAdultsPhenotypeImagingNatural History

Outcome Measures

Primary Outcomes (2)

  • Addiction Neuroimaging Assessments & blood oxygenation level

    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

    Multiple sessions

  • Addiction Neuroimaging Assessments

    structural and functional connectivity in salience, default mode, and executive control networks

    Multiple sessions

Secondary Outcomes (1)

  • AFNI, FSL, SPM and FreeSurfer software

    MRI STUDY VISIT

Study Arms (2)

Inpatient AUD

This group includes individuals who are in the alcohol use treatment.

Outpatient

This group includes individuals who are not seeking treatment for alcohol use disorder.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of outpatient and inpatient participants who are 18 years of age or older who are eligible for or enrolled in other NIAAA protocols. The participant s AUD status at the time of this study will be evaluated as part of the screening procedures of the NIAAA screening protocol 14-AA-0181. The participant s status will be determined using either the DSM-IV-TR or the DSM-5, which also classifies present AUD as mild, moderate, or severe.

You may qualify if:

  • 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).

You may not qualify if:

  • Participants should have been tested negative prior to the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be re-scheduled or withdrawn from the study.
  • Positive BrAC#,
  • Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,
  • 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),
  • Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,
  • Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,
  • Women: are pregnant#,
  • Are left-handed.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • Andrews MM, Meda SA, Thomas AD, Potenza MN, Krystal JH, Worhunsky P, Stevens MC, O'Malley S, Book GA, Reynolds B, Pearlson GD. Individuals family history positive for alcoholism show functional magnetic resonance imaging differences in reward sensitivity that are related to impulsivity factors. Biol Psychiatry. 2011 Apr 1;69(7):675-83. doi: 10.1016/j.biopsych.2010.09.049. Epub 2010 Dec 3.

    PMID: 21126735BACKGROUND

  • Baker KG, Harding AJ, Halliday GM, Kril JJ, Harper CG. Neuronal loss in functional zones of the cerebellum of chronic alcoholics with and without Wernicke's encephalopathy. Neuroscience. 1999;91(2):429-38. doi: 10.1016/s0306-4522(98)90664-9.

    PMID: 10366000BACKGROUND

  • Bjork JM, Hommer DW, Grant SJ, Danube C. Impulsivity in abstinent alcohol-dependent patients: relation to control subjects and type 1-/type 2-like traits. Alcohol. 2004 Oct-Nov;34(2-3):133-50. doi: 10.1016/j.alcohol.2004.06.012.

    PMID: 15902907BACKGROUND

Related Links

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Officials

  • Nancy Diazgranados, M.D.

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth A Lee, R.N.

CONTACT

(301) 451-6964beth.lee@nih.gov

Nancy Diazgranados, M.D.

CONTACT

(301) 496-7515nancy.diazgranados@nih.gov

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 9, 2014

Study Start

July 10, 2014

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04-08

Locations

US(1)