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OpenTrials
Completed

NCT Number: NCT04828577

Brain Network Modulation and Alcohol Use

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

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

All study procedures will take place during a single study visit. Before the imaging session, a research assistant will aid the participant to select salient images related to individualized future goals as well as alcohol images which elicit self-reported craving. All participants will complete two fMRI runs within a single session. In run 1 of the scan (offline classifier training), participants will perform an image viewing task displaying alternating blocks of these goal- and alcohol-related images. Between the image viewing blocks we will assess reinforcer pathology with brief in-scanner measures of alcohol valuation (BAAD). In total, there will be six blocks each of the goal-oriented images, alcohol-related images, and BAAD (18 blocks total). Since this is a proof-of-concept experiment, the interspersed BAAD blocks will enable monitoring and validating changes in the participant's alcohol valuation after the image viewing blocks. Only the fMRI measures of goal- and alcohol-related image viewing will be used to build a support vector classifier (SVC). The participants will see a dial with a needle on the screen along with instructions to think of either future goals or alcohol cues. The dial will be directly controlled by ongoing output from the SVC, updating the needle position as participants imagine immediate (alcohol-related) or delayed (goal-related) cues. Based on this, it is expected that participants will have increased whole-brain signal-to-noise for alcohol vs. goal fMRI analyses and increased recruitment of frontal-parietal networks from enhanced visual attention to the task.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Real Time Neurofeedback

Behavioral

Participants receive feedback from their own brain activity.

Primary outcomes

  1. Neurofeedback Control

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

    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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Fralin Biomedical Research Institute

Registry information

Acronym: RP2B

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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