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Protocol Details

Addictions Neuroclinical Assessment

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000406-AA

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology;
Alcohol Use Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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 If their test is positive, their visit may be rescheduled or they may be withdrawn from the study.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

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Eligibility

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.


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Citations:

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nancy Diazgranados, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5334
10 CENTER DR
BETHESDA MD 20892
(301) 496-7515
nancy.diazgranados@nih.gov

Megan S. Carraco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-3471
10 CENTER DR
BETHESDA MD 20814
(301) 496-5055
megan.carraco@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04946851

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