CompletedNot Applicable

A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder

United States101 participantsStarted 2018-09-20

Plain-language summary

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 to 65 who have an alcohol use disorder. * Healthy volunteers ages 21 to 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.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 21 to 65 years old
. 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)
. Alcohol use disorder (AUD) participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5) diagnosis
. Significant history of head trauma or cranial surgery.
. 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 neuro-abnormalities that, in the PI or MAI's expert opinion, interfere with research neuroimaging data, the subject may be excluded from data analysis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alcohol Attention Bias Signal - Stage 1

Timeframe: On day of fMRI scan

Change in Alcohol Craving - Stage 1

Timeframe: On day of fMRI scan

Change in Alcohol Attention Bias - Stage 2

Timeframe: Week 4 - week 1

Change in Alcohol Craving - Stage 2

Timeframe: On day of scan during week 1 and week 4

Mean Alcohol Craving Score

Timeframe: 1, 3, & 6 months after discharge

Trial details

NCT IDNCT03535129

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-03-23

Results submitted2026-03-23

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 21 to 65 years old
. 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)
. Alcohol use disorder (AUD) participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5) diagnosis
. Significant history of head trauma or cranial surgery.
. 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 neuro-abnormalities that, in the PI or MAI's expert opinion, interfere with research neuroimaging data, the subject may be excluded from data analysis.

What they're measuring

Alcohol Attention Bias Signal - Stage 1

Timeframe: On day of fMRI scan

Change in Alcohol Craving - Stage 1

Timeframe: On day of fMRI scan

Change in Alcohol Attention Bias - Stage 2

Timeframe: Week 4 - week 1

Change in Alcohol Craving - Stage 2

Timeframe: On day of scan during week 1 and week 4

Mean Alcohol Craving Score

Timeframe: 1, 3, & 6 months after discharge