Brain Network Modulation and Alcohol Use

NCT04828577 | Completed Results

• 1 other identifier: RP2B/22-016
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will use real-time fMRI neurofeedback to enhance participants' ability to control their ability to modulate alcohol valuation.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder (AUD); rt-fMRI; behavioral economics

Outcome Measures

Primary Outcomes (1)

• Neurofeedback Control

  Participants were asked to move a neurofeedback dial to "alcohol" or "goal" directions. For the "alcohol" they were instructed to attempt to crave alcohol, and for the "goal" they were instructed to attempt to project themselves into their future goals. The outcome was measured by the mean correlation of the needle movement compared to the instructed needle movement.

  During the real time fMRI scan, approximately 1 hour (single session)

Study Arms (1)

Real Time Neurofeedback

EXPERIMENTAL

Real time neurofeedback will be based on a classifier of increasing or decreasing alcohol craving/demand fMRI patterns. Participants will try to modulate their brain patterns based on neurofeedback via a visual dial during an fMRI scan. Participants will be told they will be controlling the visual dial.

Behavioral: Real Time Neurofeedback

Interventions

Real Time Neurofeedback BEHAVIORAL

Participants receive feedback from their own brain activity.

Real Time Neurofeedback

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-report alcohol abuse
• be 21 years of age or older
• have a desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period

You may not qualify if:

• meeting moderate to severe DSM-5 criteria for substance-use disorders other than alcohol or nicotine
• having a current diagnosis of any psychotic disorder
• having a history of seizure disorders or traumatic brain injury
• having any contraindication for participation in the MRI sessions
• reporting current pregnancy or lactation

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Fralin Biomedical Research Institute: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Stephen LaConte
• Organization: Virginia Tech

slaconte@vtc.vt.edu

5405262008

Study Officials

• Stephen M LaConte, PhD

  Fralin Biomedical Research Institute (FBRI) at VTC

  PRINCIPAL INVESTIGATOR

• Warren K Bickel, PhD

  Fralin Biomedical Research Institute (FBRI) at VTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: January 13, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon request after dissemination of results.
• Access Criteria: Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.

Locations

US (1)