Protocol Details

Behavioral and Functional 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 Years
Max Age: 65 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women

Keywords

fMRI;
Alcoholism;
Phenotype;
Imaging;
EEG;
Psychophysiology;
Near Infrared

Recruitment Keyword(s)

None

Condition(s)

Alcohol Dependence;
Alcohol Drinking;
Alcoholism;
Alcohol Use Disorder;
Addiction

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: 7T MRI

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 18-65 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.

Eligibility

INCLUSION CRITERIA:

-between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies*.

EXCLUSION CRITERIA:

-Are not cleared on a neuromotor examination

-Are currently receiving psychotropic medication

-Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the

past 30 days CIWA score > 8).

-MRI Exclusion Criteria:

--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;

--Are pregnant, as determined by a negative pregnancy test

--Left handed

--Claustrophobia.

*To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.


Citations:

Not Provided

Contacts:

Principal Investigator

Referral Contact

For more information:

Paule V. Joseph, C.R.N.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHBC 10 - CRC BG RM 1-5330
10 CENTER DR
BETHESDA MD 20892
(301) 827-5234
paule.joseph@nih.gov
Beth A. Lee, R.N.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 4C424
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6964
beth.lee@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:

NCT02108054
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