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Protocol Details

Characterization Imaging Instruments for Addiction Neuroimaging Assessments

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-AA-0080

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: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Alcohol;
Biomarkers;
Adults;
Phenotype;
Imaging;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Alcohol Dependence;
Alcohol Drinking;
Alcohol-Related Disorders;
Alcoholism;
Brain Mapping

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA.

Objective:

- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.

Eligibility:

- Adults age 18 and older.

Design:

- Participants will visit the NIH Clinical Center once during the study.

- Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview.

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

- Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner.

-MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.

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Eligibility

INCLUSION CRITERIA:

All adult participants must be:

-Age 18 years or older,

-Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any

NIAAA study (including 14-AA-0181).

EXCLUSION CRITERIA:

As this is a natural history protocol, there are no exclusionary criteria for this study.

Participants should have been tested negative at the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be rescheduled or withdrawn from the study.

Upon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.

-Exclusion criteria for MR scan*

--Positive BrAC#,

--Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, opiates and tetrahydrocannabinol (THC) for outpatients. Positive UDT for benzodiazepines and THC are not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes.

--Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,

--Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments),

--Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,

--Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,

--Women: are pregnant#,

--Are left-handed.

--Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score > 8.

*Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.

#Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion.


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Citations:

Andrews MM, Meda SA, Thomas AD, Potenza MN, Krystal JH, Worhunsky P, Stevens MC, O'Malley S, Book GA, Reynolds B, Pearlson GD. Individuals family history positive for alcoholism show functional magnetic resonance imaging differences in reward sensitivity that are related to impulsivity factors. Biol Psychiatry. 2011 Apr 1;69(7):675-83. doi10.1016/j.biopsych.2010.09.049. Epub 2010 Dec 3.

Baker KG, Harding AJ, Halliday GM, Kril JJ, Harper CG. Neuronal loss in functional zones of the cerebellum of chronic alcoholics with and without Wernicke's encephalopathy. Neuroscience. 1999;91(2):429-38.

Bjork JM, Hommer DW, Grant SJ, Danube C. Impulsivity in abstinent alcohol-dependent patients: relation to control subjects and type 1-/type 2-like traits. Alcohol. 2004 Oct-Nov;34(2-3):133-50.

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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@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:

NCT02108080

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