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Enrolling by invitationNCT04946851Updated Nov 9, 2026

Addictions Neuroclinical Assessment (ANA)

An observational study in Normal Physiology and Alcohol Use Disorder, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,400
Ages
18 Years to 99 Years
Sex
All
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Study summary

Background:

Alcohol use disorder (AUD) is a major public health problem. In the U.S., 16 to 18 million adults have an AUD. Researchers want to test an assessment tool called the ANA. It uses self-report and behavioral measures to assess 3 neuroscience domains of addiction. They hope to better understand, manage, prevent, and treat AUD.

Objective:

To learn how people s brains function related to their drinking.

Eligibility:

People ages 18 years and older who have enrolled in NIAAA natural history study 14-AA-0181.

Design:

Participants will complete surveys and tasks on a computer. The surveys and tasks assess a range of aspects of thinking and making decisions. The surveys and tasks also assess behaviors and feelings about alcohol and other rewards, and negative emotions. Participants will spend 90 minutes on the computer. Then they will take a break. In total, they will spend 4 blocks of time on the computer. Each block will last 90 minutes. They will take a break in between each block of time. They can take more breaks if needed.

Outpatient participants and healthy volunteers will complete this study in 1 visit. It will last about 6 hours. A second visit may be scheduled if needed. Outpatient participants will take a breath alcohol test. If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.

Inpatient participants will complete this study over several days.

Data collected from participants in this study may be combined and analyzed with their data from NIAAA study 14-AA-0181 and/or NIAAA imaging study 14-AA-0080.

Read the detailed description

Study Description:

This is a protocol examining a battery of assessments designed to study three neurofunctional domains relevant to alcohol use disorder (AUD), negative emotionality, incentive salience and executive function. The study will examine the relationships among the three ANA domains with the goal of identifying sub-types of AUD based on variation in the ANA domains.

Objectives:

Primary Objectives:

  1. To examine the relationship between the three ANA domains

    (i.e. Negative Emotionality, Incentive Salience, Executive Function).

  2. To identify the different subtypes of AUD based on variation in the ANA domains.

Secondary Objectives: None

Endpoints: Primary Endpoint: Latent factors of each of the ANA domains:

  • Negative emotionality
  • Incentive Salience
  • Executive Function

Secondary Endpoints: None

02

Conditions studied

  • Normal Physiology
  • Alcohol Use Disorder

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Keywords

  • Executive Function
  • Incentive Salience
  • Negative emotionality
  • Neurobiology
  • Alcohol Use Disorder
  • Natural History
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's planned enrollment of 1,400 is above the median of 159 across 183 observational studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The target population for this study includes adults across the spectrum of alcohol use who have been screened under the NIAAA screening protocol (14-AA-0181). This sample includes non-drinkers, light drinkers, non-treatment-seeking heavy drinkers, and treatment-seeking individuals with alcohol use disorder. Recruitment will be open to all participants from the NIAAA screening protocol.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet both of the following criteria:

  1. Participants must be > 18 years of age
  2. Participants must have enrolled in the NIAAA Screening Protocol (14-AA-0181).

Exclusion criteria

EXCLUSION CRITERIA:

There are no formal exclusionary criteria for this study. Based on enrollment criteria for the NIAAA Screening Protocol, individuals less than 18 years of age, or prisoners will not be enrolled in this study.

Outpatients will be tested for acute intoxication/impairment at the time of consent and study procedures using an alcohol breathalyzer and a clinical evaluation. Individuals with a positive breath alcohol concentration (BrAC), or those who are determined to be acutely intoxicated or impaired by the clinicians will be re-scheduled or withdrawn from the study.

In addition, individuals who are determined by the clinicians to be uncooperative or unable to provide consent, will not be invited to participate in this study. Individuals who report not being able to use a mouse and keyboard, or who are determined by the clinical research team to be unable to use a mouse and keyboard, will not be invited to participate in this study.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,400 participants (estimated)

Groups and cohorts

  • non-treatment-seeking individuals

    Participants across the spectrum of drinking (from non-drinkers to heavy drinkers) who are not interested in treatment for alcohol use disorder

  • treatment-seeking individuals with alcohol use disorder

    Volunteers with an AUD diagnosis who are seeking treatment for the condition

06

What researchers measure

Primary outcomes

  1. To examine the relationship between the three ANA domains (i.e. Negative Emotionality, Incentive Salience, Executive Function).

    Once the latent factors associated with each of the three ANA domains are identified, structural relationships between the latent factors can be modeled and described.

    Time frame: 1 visit

  2. To identify the different subtypes of AUD based on variation in the ANA domains.

    Additionally, once the latent factors are identified, they can be used to categorize individuals into latent groups (AUD subtypes) based on the variation of their scores on each of the domains.

    Time frame: 1 visit

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Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
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References and documents

Publications

  • Kwako LE, Schwandt ML, Ramchandani VA, Diazgranados N, Koob GF, Volkow ND, Blanco C, Goldman D. Neurofunctional Domains Derived From Deep Behavioral Phenotyping in Alcohol Use Disorder. Am J Psychiatry. 2019 Sep 1;176(9):744-753. doi: 10.1176/appi.ajp.2018.18030357. Epub 2019 Jan 4. PubMed 30606047 ↗
  • Kwako LE, Momenan R, Grodin EN, Litten RZ, Koob GF, Goldman D. Addictions Neuroclinical Assessment: A reverse translational approach. Neuropharmacology. 2017 Aug 1;122:254-264. doi: 10.1016/j.neuropharm.2017.03.006. Epub 2017 Mar 7. PubMed 28283392 ↗
  • Kwako LE, Momenan R, Litten RZ, Koob GF, Goldman D. Addictions Neuroclinical Assessment: A Neuroscience-Based Framework for Addictive Disorders. Biol Psychiatry. 2016 Aug 1;80(3):179-89. doi: 10.1016/j.biopsych.2015.10.024. Epub 2015 Nov 17. PubMed 26772405 ↗
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Updates

4 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and description
4 updates, last Nov 9, 2026
Show all 4 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 3, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 19, 2026
    Minor edits only
    + 1 other change: verification date
  4. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT04946851
Responsible party
Sponsor
First posted
Jul 1, 2021
Start date
Aug 12, 2021
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Nov 9, 2026

Study contacts

Nancy Diazgranados, M.D.
principal investigator · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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