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Protocol Details

Behavioral and Functional MRI Task Development, Implementation, and Testing

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-AA-0066

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

fMRI;
Alcoholism;
Phenotype;
Imaging

Recruitment Keyword(s)

None

Condition(s)

Alcohol Dependence;
Alcohol Drinking;
Alcoholism

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.

Objective:

- To develop tasks that investigate a person s behavior that can be used in later studies.

Eligibility:

- Inpatient participants of another study. They must be physically healthy right-handed adults 18 60 years old.

- Healthy right-handed volunteers 18 60 years old.

Design:

- Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.

- Participants will have between one and three visits.

- Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.

- Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.

- The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.

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Eligibility

INPATIENT PARTICIPANT WITH ALCOHOL DEPENDENCE:

a. We will study up to 100 male and 100 female individuals who meet criteria for current alcohol dependence. Inpatient participants will be recruited from the NIAAA protocol 14-AA-0181, Unit and Clinic Evaluation, Screening, Assessment, and Management

b. INCLUSION CRITERIA:

(1) Physically healthy;

(2) Between 18-60 years of age (since age effects fMRI signal in ways that have not yet been well-characterized);

c. EXCLUSION CRITERIA:

(1) Are not cleared on a neuromotor examination;

(2) Are currently receiving psychotropic medication;

(3) Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the past 30 days CIWA score greater than 8).

MRI Exclusion Criteria:

1. Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;

2. Are pregnant, as determined by a negative pregnancy test;

3. Left handed;

4. Claustrophobia;

HEALTHY VOLUNTEERS WITHOUT AN ALCOHOL USE DISORDER:

a. We will study up to 100 male and 100 female individuals who have never met criteria for an alcohol use disorder and are between the age of 18 and 60 years and will be recruited from the NIAAA creening protocols 98-AA-0009, Screening Evaluation for NIAAA Protocols, and 14-AA-0181, Unit and Clinic Evaluation, Screening, Assessment, and Management.

b. INCLUSION CRITERIA:

-Same as inpatient participants with alcohol dependence.

c. EXCLUSION CRITERIA:

-Same as inpatient participants with alcohol dependence (item 3 does not apply). In addition, healthy control participants cannot have met DSM-IV or DSM-5 criteria for an alcohol use disorder at any time.


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Citations:

Beatty WW, Tivis R, Stott HD, Nixon SJ, Parsons OA. Neuropsychological deficits in sober alcoholics: influences of chronicity and recent alcohol consumption. Alcohol Clin Exp Res. 2000 Feb;24(2):149-54.

Beck A, W(SqrRoot) stenberg T, Genauck A, Wrase J, Schlagenhauf F, Smolka MN, Mann K, Heinz A. Effect of brain structure, brain function, and brain connectivity on relapse in alcohol-dependent patients. Arch Gen Psychiatry. 2012 Aug;69(8):842-52. doi: 10.1001/archgenpsychiatry.2011.2026.

Beckmann CF, Smith SM. Tensorial extensions of independent component analysis for multisubject FMRI analysis. Neuroimage. 2005 Mar;25(1):294-311. Epub 2005 Jan 8.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Reza Momenan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 3C112
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6972
rezam@mail.nih.gov

Reza Momenan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 3C112
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6972
rezam@mail.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:

NCT02108054

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