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

NCT03535129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-04-23

Study results available
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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.

Conditions

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

Interventions

BEHAVIORAL

Real time fMRI neurofeedback

During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Melanie L Schwandt, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2025-03-23
Completion
2025-03-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535129 on ClinicalTrials.gov