NCT03535129

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

Completed NA Last updated 4 June 2025

What this trial tests

NA trial testing Real time fMRI neurofeedback in Healthy Volunteers in 104 participants. Completed in 23 March 2025.

Timeline

20 September 2018

Primary endpoint
23 March 2025

23 March 2025

Quick facts

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	104
Start date	20 September 2018
Primary completion	23 March 2025
Estimated completion	23 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Real time fMRI neurofeedback

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →
• Alcohol Drinking Related Problems — all drugs for Alcohol Drinking Related Problems →
• Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

Adults 21 to 65, any sex, with Healthy Volunteers or Alcohol Drinking Related Problems. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training.
   Fede SJ, Kisner MA, Dean SF, Kerich M, et al · · 2023 · cited 4× · PMID 37326428 · DOI 10.1111/psyp.14367
2. Alcohol attention bias modulates neural engagement during moral processing.
   Fede SJ, Kisner MA, Dean SF, Buckler E, et al · · 2024 · PMID 39038485 · DOI 10.1080/17470919.2024.2377666