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Protocol Details

Development of Neuroimaging Methods to Assess the Neurobiology of Addiction

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-AA-0186

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: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking;
Adults who are or may become unable to consent;
Pregnant Women

Keywords

fMRI;
EEG

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: In vivo MRS
Other: fMRI
Other: EEG/EOG
Other: Stimulation tasks
Other: NSPRD
Other: Structural MRI

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

Abusing alcohol, drugs, and other substances can cause serious health problems. These substances also can affect brain function. Researchers want to learn more about brain function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio waves to take pictures of the brain.

Objective:

To develop new ways to use MRI to study the brain.

Eligibility:

Healthy people 18 years of age or older.

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests.

They will answer questions about their drug use and psychiatric history. They will be asked about family history of alcoholism or drug abuse.

Participants will answer questions to see if they can participate in MRI.

Participants will have MRI scans. 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. A device called a coil may be placed over the head.

Each sub-study will include up to 3 different MRI visits. Participants can be in multiple sub-studies. But they can have only 1 MRI per week and 20 per year.

During MRI visits, participants may have urine collected. They may get another MRI questionnaire.

Participants may have a clinical MRI brain scan. This may show physical problems in the brain.

During some scans, participants may perform simple movement, memory, and thinking tasks.

Participants may be connected to a machine to monitor brain activity during the scan. Small metal electrodes will be placed on the scalp. A gel will be placed in the space between the electrodes and the scalp.

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Eligibility

INCLUSION CRITERIA:

1. Eighteen years or older.

2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent.

3. Willingness to abstain from drug use on scheduled testing days.

EXCLUSION CRITERIA

1. Positive urine pregnancy test in females.

2. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to 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) or fear of enclosed spaces as determined by the self-report checklist.

3. Claustrophobia.

4. Body weight >550 lbs, which is the weight limit of the MR scanner.

5. Current DSM-5 diagnosis of a psychiatric disorder (other than nicotine/caffeine use disorders) as determined by history and clinical exam including substance use disorder, alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it was severe enough as to require hospitalization (any length), or chronic medication management (more than 4 weeks), or that could impact brain function at the time of the study. Subjects receiving psychotherapy may be included in the study.

6. Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month.

7. Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy.

8. Currently taking any psychoactive drugs such as Celexa (TM), Prozac (TM), Wellbutrin (TM), Zoloft (TM), and/or stimulants other than caffeine such as Adderall (TM), Dexedrine (TM) and Ritalin (TM). Subjects taking PRN medications (e.g., sleep medications) may be included in the study.

9. Clinically significant laboratory or examination results.

10. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).

11.*Non-English speakers (must also be able to read and comprehend English).

*The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since our fMRI paradigms (particularly the Delay Discounting task) require that the subject be able to speak, read and comprehend English.

Subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs/alcohol on initial screening. However, if they test positive on scheduled study procedure days involving MRI, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug or BAL screens. If the drug/BAL tests is/are positive on the third rescheduled visit, the participant will be withdrawn from the study.


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Citations:

Tomasi D, Wang GJ, Studentsova Y, Volkow ND. Dissecting Neural Responses to Temporal Prediction, Attention, and Memory: Effects of Reward Learning and Interoception on Time Perception. Cereb Cortex. 2014 Nov 11. pii: bhu269. [Epub ahead of print]

Tomasi D, Caparelli EC, Chang L, Ernst T. fMRI-acoustic noise alters brain activation during working memory tasks. Neuroimage. 2005 Aug 15;27(2):377-86.

Tomasi D, Wang R, Wang GJ, Volkow ND. Functional connectivity and brain activation: a synergistic approach. Cereb Cortex. 2014 Oct;24(10):2619-29. doi: 10.1093/cercor/bht119. Epub 2013 May 3.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Dardo G. Tomasi, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room B2L304
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1589
dardo.tomasi@nih.gov

Dardo G. Tomasi, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room B2L304
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1589
dardo.tomasi@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:

NCT02535702

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