Addictions Neuroclinical Assessment (ANA)

Addictions Neuroclinical Assessment

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 If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.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....

Study Overview

• Status: Enrolling by invitation
• Conditions: Normal Physiology; Alcohol Use Disorder

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

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

• 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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 visit
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.	1 visit

Collaborators and Investigators

• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Nancy Diazgranados, M.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 29, 2026
• Last Verified: June 23, 2026

More Information

Terms related to this study

• Keywords: Natural History; Neurobiology; Executive Function; Alcohol Use Disorder; Incentive Salience; Negative emotionality
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 10000406; 000406-AA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No