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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how neurofeedback, a technique providing real-time feedback on brain activity, might help treat alcohol use disorder. Researchers aim to understand brain responses when individuals who drink alcohol view images related to social settings or alcohol, and whether they can learn to control their brain activity to manage their drinking. Participants will undergo MRI scans while performing tasks and may receive feedback on their brain activity through real-time fMRI neurofeedback. The study is suitable for adults aged 21 to 65 with alcohol use disorder or healthy volunteers who drink within certain limits. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for alcohol use disorder.

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 prior data suggests that neurofeedback is safe for treating alcohol use disorder?

Research has shown that real-time fMRI neurofeedback in studies with people, including those with alcohol use disorder, has not raised major safety concerns. Previous results suggest this method can help individuals manage their symptoms. Participants in these studies did not experience significant side effects, indicating that the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about real-time fMRI neurofeedback for Alcohol Use Disorder because it offers a unique approach compared to standard treatments like medication or counseling. Unlike traditional methods, this technique gives patients real-time feedback on their brain activity, helping them learn to control it consciously. This innovative approach targets the brain's reward system directly, which could lead to more effective management of cravings and reduce relapse rates. By engaging patients in actively training their brains, this method has the potential to empower individuals with a more hands-on role in their recovery journey.

What evidence suggests that neurofeedback is effective for alcohol use disorder?

Research has shown that real-time fMRI neurofeedback can help treat alcohol use disorder. Some studies found that this technique temporarily reduces alcohol cravings and lowers drinking levels. It might also decrease anxiety and depression, often linked to problem drinking. By providing feedback on brain activity, this method helps individuals learn to control their brain responses, potentially leading to better drinking habits. Early results are promising, but further research is needed to confirm long-term benefits. Participants in this trial will join a main clinical trial with random assignment to explore these potential benefits further. ^{2 6 7 8 9}

Who Is on the Research Team?

Abdolreza Momenan, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. 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 ...

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06969937

Ketamine and Neurofeedback as Combined Therapeutic ... Can the investigators observe a positive, significant therapeutic effect by comparing changes in alcohol use via i) mean alcohol use per day, ii) heavy drinking ...

4. 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 ...

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

Real-time fMRI-based neurofeedback to restore brain ... Neurofeedback training versus treatment-as-usual for alcohol dependence: results of an early-phase randomized controlled trial and neuroimaging correlates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5773029/

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5048603/

Neurofeedback training for alcohol dependence versus ... Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT for relapse prevention in alcohol dependence.

8. 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.

9. 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 ...