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Protocol Details

Investigating a Response Modulation Hypothesis of Socioemotional Processing associated with Alcohol Use Disorder

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-AA-0098

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 65

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Functional Magnetic Resonance Imaging (fMRI);
Neurofeedback;
Drug Relapse

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers;
Alcohol Drinking Related Problems;
Alcohol-Related Disorders

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person s social behavior and brain structure, but researchers don t have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking.

Objectives:

To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking.

Eligibility:

Adults ages 21 65 who have an alcohol use disorder.

Healthy volunteers ages 21 65

Design:

Participants will be screened with

Physical exam

Medical history

Blood, urine, and heart tests

Mental health interview

Questions about their alcohol drinking.

At each session, participants will have:

A urine test for drugs and pregnancy. If they test positive, they cannot participate.

A breath alcohol test and assessment for alcohol withdrawal.

Participants will complete surveys, talk to researchers about behaviors, and play games.

Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1 2 hours.

Participants will do tasks in the scanner:

They will look at pictures, sometimes of alcohol.

They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else s changes.

Participants may have follow-up phone questions at least 3 times over about 6 months.

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Eligibility

INCLUSION CRITERIA:

Stage 1:

INCLUSION CRITERIA:

1. 21 to 65 years old

2. Physically healthy

3. Healthy volunteers only: Consuming on average 7 or less standard drinks/week if female; 14 or less standard drinks/week if male (as determined by the most recent measurement within the past 90 days Alcohol Timeline Followback)

4. AUD participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent SCID 5 diagnosis

EXCLUSION CRITERIA:

1. Significant history of head trauma or cranial surgery

2. History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research. Posthoc, clinical MRI scans done according to NIH Clinical Center policy may be reviewed and if there is evidence from that scan of past or current neuroabnormalities that, in the PI or MAI s expert opinion, interfere with research neuroimaging data, the subject may be excluded from data analysis.

3. Healthy volunteers only: Have fulfilled DSM-5 criteria for a current substance or alcohol use disorder

4. Female participants only: Currently pregnant

5. Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire of the screening protocol 14-AA-0181

6. History of non-substance related psychosis

7. Lack of experience with alcohol (defined as less than 3 lifetime drinks reported in history and physical or on Lifetime Drinking History)

Stage 2:

INCLUSION CRITERIA:

1. 21 to 65 years old

2. Physically healthy

3. Inpatient currently seeking treatment for alcohol use disorder

EXCLUSION CRITERIA:

1. Significant history of head trauma or cranial surgery,

2. History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.

3. Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire of the screening protocol 14-AA-0181

4. History of non-substance related psychosis

5. Female participants only: Currently pregnant


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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)



Samantha J. Fede
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 1-5417
10 Center Drive
Bethesda, Maryland 20892
(301) 594-7416
samantha.fede@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:

NCT03535129

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