Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04946851
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-17
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addictions Neuroclinical Assessment (ANA)
Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Organization:
Study Overview
Official Title:
Addictions Neuroclinical Assessment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.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....
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000406-AA | None | None | View |