Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1400 participants
OBSERVATIONAL
2021-08-12
2031-12-31
Brief Summary
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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 If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.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
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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
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
treatment-seeking individuals with alcohol use disorder
Volunteers with an AUD diagnosis who are seeking treatment for the condition
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Participants must be \> 18 years of age
2. Participants must have enrolled in the NIAAA Screening Protocol (14-AA-0181).
Exclusion Criteria
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.
18 Years
99 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Responsible Party
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Principal Investigators
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Nancy Diazgranados, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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References
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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. Erratum In: Am J Psychiatry. 2019 Jun 1;176(6):489. doi: 10.1176/appi.ajp.2019.1766correction2.
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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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000406-AA
Identifier Type: -
Identifier Source: secondary_id
10000406
Identifier Type: -
Identifier Source: org_study_id