Real-Time Neurofeedback for Alcoholism

(RP2B Trial)

Overseen By Jeremy E Myslowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Substance-use disorders, Psychotic disorder, Seizure disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people reduce alcohol consumption through real-time brain feedback. Participants will receive neurofeedback in an MRI machine, allowing them to see and control their brain's response to delaying rewards. The study will compare this method, known as Real-Time Neurofeedback, to a sham version that does not provide real feedback. It suits individuals who drink heavily, wish to cut down, and do not plan to start other treatments soon. As an unphased trial, this study provides a unique opportunity to explore innovative methods for reducing alcohol consumption without the constraints of traditional trial phases.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a moderate to severe substance-use disorder other than alcohol or nicotine, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that real-time neurofeedback is safe for treating alcoholism?

Research has shown that real-time fMRI neurofeedback is generally safe. Studies involving individuals with alcohol use disorder have not identified any major safety issues, indicating that the treatment is well-tolerated. Participants use brain imaging feedback to help control certain behaviors. So far, these studies have reported no major negative side effects. This provides some confidence in the treatment's safety for those considering joining a clinical trial involving real-time neurofeedback. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for alcoholism, like medications and behavioral therapy, focus on reducing cravings or changing drinking habits. But this new approach, real-time neurofeedback, works differently by harnessing brain activity. Participants see a visual dial that reflects their brain's delay discounting patterns—essentially, how they value immediate versus future rewards—and they learn to adjust these patterns during a brain scan. Researchers are excited because this method could help retrain the brain's reward system, potentially offering a fresh, brain-based way to tackle addiction.

What evidence suggests that real-time neurofeedback is effective for alcoholism?

Research has shown that real-time neurofeedback, a treatment in this trial, can help individuals with substance use issues, such as alcoholism, by reducing cravings. One study found that this treatment enabled participants to control their brain activity, leading to reduced alcohol consumption. Another study discovered that neurofeedback could temporarily lower alcohol cravings and reduce anxiety and depression. The goal is to train the brain to react differently to cravings, making it easier to resist the urge to drink. Overall, these studies support neurofeedback's potential to aid those struggling with alcohol use. Participants in this trial will receive either real-time neurofeedback or an "idealized"/sham neurofeedback as a comparator. ^{1 2 5 6 7}

Who Is on the Research Team?

Warren K Bickel, PhD

Principal Investigator

Fralin Biomedical Research Institute (FBRI) at VTC

Stephen M LaConte, PhD

Principal Investigator

Fralin Biomedical Research Institute (FBRI) at VTC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 21 years old or older.

demonstrate high-risk or harmful drinking (AUDIT>15)

I want to reduce or stop my drinking but don't plan to seek alcohol use disorder treatment soon.

Exclusion Criteria

reporting current pregnancy or lactation

having any contraindication for participation in the MRI sessions

I have been diagnosed with a psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single Study Visit

Participants undergo a single study visit including fMRI scans and neurofeedback sessions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Idealized/Sham Neurofeedback
• Real Time Neurofeedback

Trial Overview 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.

How Is the Trial Designed?

Group I: Real Time Neurofeedback Experimental Treatment 1 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 Neurofeedback Placebo Group 1 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.

Real Time Neurofeedback is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Real-Time fMRI Neurofeedback for:

• Alcohol addiction
• Substance abuse
• Neurological disorders

Approved in European Union as rt-fMRI-NF for:

• Alcohol addiction
• Substance abuse
• Anxiety disorders

Approved in Japan as Decoded Neurofeedback for:

• Anxiety disorders
• Phobias
• Neurological disorders

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Fralin Biomedical Research Institute

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

In a study involving 52 patients with alcohol dependence, real-time functional MRI (rtfMRI) neurofeedback showed targeted modulation of brain responses associated with cravings, indicating a potential mechanism for reducing craving-related neural activation.

Although the rtfMRI neurofeedback did not lead to significantly better abstinence rates after 3 months compared to a placebo, the active group exhibited decreased brain activity in certain areas during training, suggesting that it may help some individuals manage their cravings more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of FMRI-based neurofeedback training in patients with alcohol dependence: a pilot study. Karch, S., Krause, D., Lehnert, K., et al.[2023]

In a study involving 38 heavy drinking students, real-time functional magnetic resonance imaging neurofeedback (rtfMRI NF) successfully reduced activation in the ventral striatum, a brain region associated with craving for alcohol, specifically in the group receiving real feedback.

The results suggest that rtfMRI NF could be a promising tool for treating alcohol addiction by helping individuals learn to downregulate their brain's response to alcohol-related cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. Kirsch, M., Gruber, I., Ruf, M., et al.[2022]

This study investigates the use of real-time functional magnetic resonance imaging (rtfMRI) neurofeedback training (NFT) in alcohol-dependent patients to help them manage cravings and prevent relapse, with participants receiving six NFT sessions over four months.

The primary goal is to determine if NFT can effectively teach participants to regulate their brain responses to alcohol-related stimuli, potentially leading to reduced alcohol consumption, as measured by various metrics such as days abstinent and drinking frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. Cox, WM., Subramanian, L., Linden, DE., et al.[2022]

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) shows promise as a treatment tool for addiction by helping individuals self-regulate brain activity related to cravings, particularly in substance users like nicotine, alcohol, and cocaine users.

While rtfMRI-nf has potential for clinical application, further research is necessary to refine study designs and establish its effectiveness as a practical treatment for addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies. Martz, ME., Hart, T., Heitzeg, MM., et al.[2023]

A clinical trial involving 52 alcohol-dependent patients showed that neurofeedback training (NFT) using real-time functional MRI (rtfMRI) is feasible and can help patients modulate their brain responses to alcohol cues, potentially aiding in relapse prevention.

Both the treatment group receiving NFT and the control group showed very low relapse rates, indicating that while NFT is a promising add-on treatment, standard care alone may also be effective in maintaining abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates. Subramanian, L., Skottnik, L., Cox, WM., et al.[2022]

In a study involving 30 adults with alcohol use disorder, real-time fMRI neurofeedback (rt-fMRI-NF) showed promise in helping participants downregulate brain activity related to cravings, particularly in key areas like the insula and dorsolateral prefrontal cortex.

The study found that using multi-region neurofeedback was more effective than support vector machine methods, especially in reducing self-reported cravings, indicating that specific feedback techniques may enhance the efficacy of craving regulation training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training. Fede, SJ., Kisner, MA., Dean, SF., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29343230/

The SyBil-AA Real-Time fMRI Neurofeedback Study Discussion: The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9095551/

Functional and clinical outcomes of FMRI-based ... This study investigates the application of real-time functional MRI (rtfMRI) neurofeedback (NF) to foster resistance towards craving-related neural activation ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424003348

Real-time fMRI-based neurofeedback to restore brain ... fMRI-neurofeedback has been used to target brain dysfunction in substance use disorders (SUDs) and to reduce craving, but a systematic synthesis of up-to-date ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-1604-3

The SyBil-AA real-time fMRI neurofeedback study The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback training in ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15622975.2022.2151043

The efficacy of neurofeedback for alcohol use disorders These alternative neurological therapies have been demonstrated to lower alcohol cravings and consumption temporarily, reduce anxiety and depression scores.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04828577?tab=history&a=1

Record History | ver. 1: 2021-03-30 | NCT04828577 Differences in alcohol demand will be compared between neurofeedback groups. [Time Frame: During the real time fMRI scan, approximately 1 hour]. Alcohol Demand.

7. withpower.com withpower.com/trial/phase-alcohol-drinking-8-2018-e6a16

Neurofeedback for Alcohol Use Disorder · Info for Participants Real-time fMRI neurofeedback has been used in studies with humans, including those with alcohol use disorder, without reports of significant safety concerns. It ...