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Protocol Details

Cross-Sectional and Longitudinal Study of Structural Imaging

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-AA-0203

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 30
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Alcoholism;
MRI;
Structural MRI;
Cerebellum

Recruitment Keyword(s)

None

Condition(s)

Alcohol Dependence

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders.

Objectives:

To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops.

Eligibility:

People with alcohol dependence who are currently hospitalized in a particular unit at NIH.

Healthy volunteers 30 60 years old without an alcohol use disorder.

Design:

Participants will be screened under a separate protocol.

Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test.

At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.

They will do behavior and memory tasks outside the scanner.

They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed.

They will have tests of memory, thinking, and problem solving.

Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks.

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Eligibility

INCLUSION CRITERIA:

1. 30 to 60 years old

2. Physically healthy

3. Healthy volunteers only: Currently consuming 7 or less standard drinks per week if female; 14 or less drinks per week if male.

EXCLUSION CRITERIA:

1. Significant history of head trauma or cranial surgery,

2. History of diabetes or stroke which requires medical intervention,

3. Clinical or laboratory evidence of severe hepatic disease as determined by ALT or AST greater than 5 times the upper normal limit, INR greater than 2.0, total bilirubin greater than 2.5 mg/dL, and albumin lower than 3.0 g/dL.

4. Positive HIV test.

5. Healthy volunteers only: 5 or more binge drinking episodes in the past 30 days (5 or more standard drinks on one occasion for males, 4 or more standard drinks on one occasion for females within two hours)

6. Healthy volunteers only:

--Have fulfilled DSM-IV or DSM-5 criteria for current alcohol use disorder or substance abuse disorder

7. Inpatient participants only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the past 30 days CIWA score > 8)

8. Female participants only: Are currently pregnant

9. IPresence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire

10. Have calustrophobia


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Reza Momenan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)



Kelsey K. Sundby
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 1-5428
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5630
kelsey.sundby@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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02564991

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