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Behavioral Intervention
Real-Time Neurofeedback for Alcoholism (RP2B Trial)
N/A
Recruiting
Led By Stephen M LaConte, PhD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
be 21 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following the real time fmri scan
Awards & highlights
RP2B Trial Summary
This trial helps people use brain feedback to control drinking and value of alcohol, so they can make better choices.
Who is the study for?
This trial is for adults over 21 who drink heavily (AUDIT>15) and want to reduce their drinking but aren't planning to get treatment during the study. It's not for those with MRI contraindications, pregnant or breastfeeding women, people with psychotic disorders, severe drug use issues besides alcohol or nicotine, seizures, or brain injuries.Check my eligibility
What is being tested?
The study tests if real-time fMRI neurofeedback can help participants control their impulse to choose immediate rewards over larger future ones ('delay discounting'), potentially affecting how they value alcohol and their consumption behavior.See study design
What are the potential side effects?
Since this trial involves non-invasive fMRI neurofeedback rather than medication, typical drug side effects are not expected. However, some may experience discomfort from lying still in the MRI machine or anxiety related to the procedure.
RP2B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
RP2B Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following the real time fmri scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following the real time fmri scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol Demand
Delay Discounting
RP2B Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Real Time NeurofeedbackExperimental Treatment1 Intervention
Real time neurofeedback will be based on a classifier of increasing or decreasing delay discounting fMRI patterns. Participants will try to modulate their discounting rate based on neurofeedback via a visual dial, during an fMRI scan. Participants will be told they will be controlling the visual dial.
Group II: "Idealized"/Sham NeurofeedbackPlacebo Group1 Intervention
Rather than using the output of a classifier, the visual dial will display perfect "modulation" of increasing and decreasing delay discounting and participants will told that they will not be controlling the visual dial.
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
142 Previous Clinical Trials
27,657 Total Patients Enrolled
6 Trials studying Alcoholism
1,120 Patients Enrolled for Alcoholism
Fralin Biomedical Research InstituteUNKNOWN
Stephen M LaConte, PhDPrincipal InvestigatorFralin Biomedical Research Institute (FBRI) at VTC
2 Previous Clinical Trials
242 Total Patients Enrolled
2 Trials studying Alcoholism
242 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.I want to reduce or stop my drinking but don't plan to seek alcohol use disorder treatment soon.I have been diagnosed with a psychotic disorder.You have a serious addiction to drugs other than alcohol or nicotine, as defined by the DSM-5.I have a history of seizures or traumatic brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Real Time Neurofeedback
- Group 2: "Idealized"/Sham Neurofeedback
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alcoholism Patient Testimony for trial: Trial Name: NCT04828577 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial presently open for enrollment?
"This experiment, initially posted on January 13th 2023, is actively seeking out eligible patients according to information provided by clinicaltrials.gov. The trial's parameters were last updated on February 14th 2023."
Answered by AI
How extensive is the participation in this research endeavor?
"Affirmative. Clinicaltrials.gov stands as evidence that this clinical trial, which was first posted on January 13th 2023, is actively recruiting participants. Approximately 100 individuals are needed at a single medical site for the study to be successful."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Fralin Biomedical Research Institute at VTC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am hoping to reduce my alcohol consumption.
PatientReceived 1 prior treatment
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