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Brain Network Modulation and Alcohol Use

Brain Network Modulation and Alcohol Use

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04828577
Acronym
RP2B
Enrollment
21
Registered
2021-04-02
Start date
2023-01-13
Completion date
2025-08-31
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder (AUD)

Keywords

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

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALReal Time Neurofeedback

Participants receive feedback from their own brain activity.

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER
Fralin Biomedical Research Institute
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neurofeedback ControlDuring 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephen M LaConte, PhD

Fralin Biomedical Research Institute (FBRI) at VTC

PRINCIPAL_INVESTIGATORWarren K Bickel, PhD

Fralin Biomedical Research Institute (FBRI) at VTC

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
16 Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 21
other
Total, other adverse events
0 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026