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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
Must not have
having a current diagnosis of any psychotic disorder
having a history of seizure disorders or traumatic brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following the real time fmri scan
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a psychotic disorder.
Select...
I have a history of seizures or traumatic brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the real time fmri scan, approximately 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the real time fmri scan, approximately 1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol Demand
Delay Discounting
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.
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
156 Previous Clinical Trials
25,645 Total Patients Enrolled
6 Trials studying Alcoholism
1,155 Patients Enrolled for Alcoholism
Fralin Biomedical Research InstituteUNKNOWN
Stephen M LaConte, PhDPrincipal InvestigatorFralin Biomedical Research Institute (FBRI) at VTC
2 Previous Clinical Trials
277 Total Patients Enrolled
2 Trials studying Alcoholism
277 Patients Enrolled for Alcoholism
Warren K Bickel, PhDPrincipal InvestigatorFralin Biomedical Research Institute (FBRI) at VTC
9 Previous Clinical Trials
1,167 Total Patients Enrolled
4 Trials studying Alcoholism
381 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