Neurofeedback for Alcohol Use Disorder

Overseen By Beth A Lee, R.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Disqualifiers: Head trauma, Neurological disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

104 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, they will collect information on any medications you are taking to consider in their analysis.

What data supports the effectiveness of the treatment Real time fMRI neurofeedback for Alcohol Use Disorder?

Real-time fMRI neurofeedback has shown potential in helping people with alcohol use disorder by reducing brain activity related to cravings, as seen in studies where participants successfully decreased craving-related brain activity and showed improved self-control over these cravings. While more research is needed, these findings suggest that this treatment could help manage alcohol cravings and support abstinence. ^{1 2 3 4 5}

Is real-time fMRI neurofeedback safe for humans?

Real-time fMRI neurofeedback has been used in studies with humans, including those with alcohol use disorder, without reports of significant safety concerns. It involves using MRI technology to help individuals regulate brain activity, and while more research is needed, it appears to be generally safe as a non-invasive technique. ^{1 2 4 5 6}

How does neurofeedback treatment differ from other treatments for alcohol use disorder?

Neurofeedback treatment for alcohol use disorder is unique because it uses real-time functional MRI to help patients learn to control brain activity related to cravings. Unlike traditional treatments, this method provides immediate feedback on brain function, allowing individuals to actively modulate their neural responses to alcohol-related cues. ^{1 2 4 5 6}

What is the purpose of this trial?

Background: Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person s social behavior and brain structure, but researchers don t have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking. Objectives: To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking. Eligibility: Adults ages 21 65 who have an alcohol use disorder. Healthy volunteers ages 21 65 Design: Participants will be screened with Physical exam Medical history Blood, urine, and heart tests Mental health interview Questions about their alcohol drinking. At each session, participants will have: A urine test for drugs and pregnancy. If they test positive, they cannot participate. A breath alcohol test and assessment for alcohol withdrawal. Participants will complete surveys, talk to researchers about behaviors, and play games. Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1 2 hours. Participants will do tasks in the scanner: They will look at pictures, sometimes of alcohol. They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else s changes. Participants may have follow-up phone questions at least 3 times over about 6 months.

Research Team

Abdolreza Momenan, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria

Adults aged 21-65 with moderate to severe alcohol use disorder (AUD) and healthy volunteers who drink minimally are eligible. AUD participants must be diagnosed according to SCID 5 criteria and may include inpatients seeking treatment for AUD. Healthy individuals should consume less than 7 drinks/week for females, or 14 drinks/week for males.

Inclusion Criteria

Stage 1: Healthy volunteers only: Consuming on average 7 or less standard drinks/week if female; 14 or less standard drinks/week if male (as determined by the most recent measurement within the past 90 days Alcohol Timeline Followback)

I am in the hospital seeking treatment for alcohol use.

I am between 21 and 65 years old.

Exclusion Criteria

I am currently pregnant.

I do not have any neurological conditions that would affect brain imaging studies.

History of non-substance related psychosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Stage 1: Pilot Portion

Participants undergo fMRI while looking at socioemotional stimuli and alcohol cues, and pilot a neurofeedback training protocol.

4 weeks

Multiple sessions (in-person)

Stage 2: Main Clinical Trial

Inpatient participants with alcohol use disorder receive active or sham neurofeedback, including fMRI sessions and real-time neurofeedback during alcohol craving.

8 weeks

Multiple sessions (in-person)

Follow-up

Participants are contacted to assess outcomes related to alcohol craving, attention bias, and community functioning.

6 months

3 follow-up phone calls

Treatment Details

Interventions

• Real time fMRI neurofeedback

Trial Overview The trial is testing real-time fMRI neurofeedback to understand brain activity related to socioemotional processing in people with AUD when exposed to social and alcohol-related images, aiming to see if controlling this activity can help treat problem drinking.

Participant Groups

Group I: Stage 2 Experimental Treatment 1 Intervention

Main Clinical Trial with random assignment

Group II: Stage 1 Active Control 1 Intervention

Pilot portion to optimize intervention and achievecorrelational research aims

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials

865

Recruited

1,091,000+

Findings from Research

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]

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]

The study found that patients with tobacco use disorder who remained abstinent for at least 3 months showed reduced brain activity in specific areas during their first real-time fMRI neurofeedback session, indicating a potential marker for successful treatment outcomes.

In contrast, patients who relapsed exhibited heightened brain responses, particularly in the anterior cingulate cortex and other related areas, suggesting that these neural responses could help predict which patients are more likely to succeed in quitting smoking after neurofeedback training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time fMRI Neurofeedback in Patients With Tobacco Use Disorder During Smoking Cessation: Functional Differences and Implications of the First Training Session in Regard to Future Abstinence or Relapse. Karch, S., Paolini, M., Gschwendtner, S., et al.[2020]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging neurofeedback can reduce striatal cue-reactivity to alcohol stimuli. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of FMRI-based neurofeedback training in patients with alcohol dependence: a pilot study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time fMRI Neurofeedback in Patients With Tobacco Use Disorder During Smoking Cessation: Functional Differences and Implications of the First Training Session in Regard to Future Abstinence or Relapse. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Selecting an optimal real-time fMRI neurofeedback method for alcohol craving control training. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. [2022]