Addictions Neuroclinical Assessment (ANA)

• Conditions: Normal Physiology; Alcohol Use Disorder

• Registration Number: NCT04946851
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.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

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 Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-01
• Study Start: 2021-08-12
• Status Verified: 2025-05-20
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the relationship between the three ANA domains (i.e. Negative Emotionality, Incentive Salience, Executive Function).	1 visit	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.
To identify the different subtypes of AUD based on variation in the ANA domains.	1 visit	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.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States