Neurofeedback + Body-Mind Training for Substance Abuse

Overseen By YiYuan Tang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: CNS medications

Disqualifiers: Psychiatric diagnoses, CNS disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 months

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining neurofeedback (NF) and integrative body-mind training (IBMT) can assist individuals with substance use issues. IBMT combines mindfulness and relaxation techniques to reduce stress and enhance self-control. NF provides real-time brain activity feedback to improve self-control, potentially amplifying IBMT's effects. The trial includes various groups testing these method combinations. It seeks participants with recent frequent alcohol, cannabis, or tobacco use, excluding those with other psychiatric conditions or prior experience with meditation or NF.

As an unphased trial, this study presents a unique opportunity to explore innovative methods for enhancing self-control and reducing substance use.

Will I have to stop taking my current medications?

The trial requires participants to be free of any psychiatric medications and medications that affect the central and autonomic nervous system. If you are taking such medications, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Integrative Body-Mind Training (IBMT) and Neurofeedback (NF) are usually easy for people to handle. Studies on mindfulness practices like IBMT indicate they generally have few risks, though limited research exists on potential harms, so this should be considered.

For neurofeedback, studies have found it can be useful for treating addiction. It has been used to lower anxiety and assist people with substance use issues, suggesting it is generally safe.

Combining IBMT with NF might enhance the benefits of each. However, specific safety information on using them together is limited. On their own, both treatments appear safe based on current research.

For those considering joining a trial, this information may help in understanding the treatment's safety. Discuss any concerns with the study coordinators or a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Neurofeedback (NF) and Integrative Body-Mind Training (IBMT) combination because these techniques offer a fresh approach to treating substance abuse. Unlike traditional treatments, which often rely on medication or counseling, IBMT focuses on enhancing mindfulness and self-control through a blend of body-awareness and mental exercises. NF, on the other hand, provides real-time feedback to help individuals strengthen their self-control networks in the brain. Together, these methods can potentially reduce substance use more effectively by promoting brain plasticity and improving stress management, setting them apart from standard care options.

What evidence suggests that this trial's treatments could be effective for substance abuse?

Research has shown that integrative body-mind training (IBMT), one of the treatments in this trial, can reduce stress and improve self-control, both crucial for managing substance use. Studies have found that the mindfulness exercises in IBMT decrease cravings and aid in managing emotions. Neurofeedback (NF), another treatment option in this trial, provides real-time feedback to enhance self-control, potentially reducing impulsive behavior and cravings. Evidence suggests that NF effectively lessens addiction symptoms and improves mental health for those with substance use disorders. This trial will also explore the combined use of IBMT and NF, as they may enhance each other's benefits, potentially making treatment for substance abuse more effective. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals struggling with substance abuse. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be involved in other conflicting treatments or studies.

Inclusion Criteria

Written informed consent

My vision is normal or corrected to normal with glasses or contacts.

No previous meditation or NF experiences

Exclusion Criteria

Excluding cannabis, evidence of recent (past month) illicit drug use

Any psychiatric diagnoses other than an SUD

I do not have any brain disorders, am not on CNS affecting meds, and am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo integrative body-mind training (IBMT) with or without neurofeedback (NF) to reduce polysubstance use

3 months

Visits at baseline, 2-4 weeks, and 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IBMT
• NF

Trial Overview The study is examining if neurofeedback (NF) can enhance the effects of integrative body-mind training (IBMT), a meditation-like practice, to help reduce substance use.

How Is the Trial Designed?

Group I: NF Experimental Treatment 1 Intervention

An evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF.

Group II: IBMT + NF Experimental Treatment 2 Interventions

The combined IBMT and NF also show positive effects in reducing substance use.

Group III: IBMT Experimental Treatment 1 Intervention

An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components.

Group IV: Sham NF Placebo Group 1 Intervention

Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.

IBMT is already approved in China, United States for the following indications:

Approved in China as IBMT for:

• Anxiety
• Depression
• Stress-related disorders
• Addiction
• PTSD
• TBI

Approved in United States as IBMT for:

• Research purposes only, not approved for clinical use

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Published Research Related to This Trial

Neurofeedback training (NFT) focusing on the beta/theta ratio (BTR) significantly influenced brain activity beyond the training location, affecting parietal, central, and frontal regions in 11 healthy volunteers over 25 sessions.

The study found that changes in BTR and theta amplitude were most pronounced in the parietal region, likely due to its proximity to the occipital training site, suggesting that the effects of NFT can extend to other brain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta/theta ratio neurofeedback training effects on the spectral topography of EEG. Yang, L., Nan, W., Qu, X., et al.[2020]

In a study involving 14 alcoholic outpatients, 20 sessions of alpha-theta brainwave neurofeedback training led to significant reductions in self-reported depression and various psychological symptoms, indicating its potential efficacy in treating alcohol abuse and associated mental health issues.

Follow-up data after 21 months showed that participants who completed the brainwave neurofeedback training had a sustained prevention of relapse into alcohol use, suggesting long-term benefits of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha-theta brainwave neurofeedback training: an effective treatment for male and female alcoholics with depressive symptoms. Saxby, E., Peniston, EG.[2022]

A 19-year-old male college student with a history of severe polydrug misuse showed significant improvement in mental health after 11 sessions of neurofeedback combined with short-term psychodynamic psychotherapy, with psychopathology levels dropping almost to zero.

The neurofeedback training focused on SMR/theta waves was positively associated with clinical improvement, particularly in reducing symptoms measured by the Brief Psychiatric Rating Scale, while alpha/theta training did not show similar benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG-neurofeedback and psychodynamic psychotherapy in a case of adolescent anhedonia with substance misuse: mood/theta relations. Unterrainer, HF., Chen, MJ., Gruzelier, JH.[2022]

The EEG biofeedback protocol significantly improved treatment retention, with participants in the biofeedback group staying in treatment longer than the control group (p < 0.005).

After one year, 77% of participants who completed the EEG biofeedback protocol were abstinent from substance use, compared to only 44% in the control group, indicating a strong efficacy in promoting long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an EEG biofeedback protocol on a mixed substance abusing population. Scott, WC., Kaiser, D., Othmer, S., et al.[2022]

A novel alpha-theta brainwave biofeedback training program for chronic alcoholics resulted in significant increases in alpha and theta brainwave activity, along with reductions in self-assessed depression, indicating its potential efficacy as a treatment.

Follow-up data over 13 months showed that alcoholics who completed the brainwave training had sustained prevention of relapse, suggesting long-term benefits of this relaxation therapy compared to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha-theta brainwave training and beta-endorphin levels in alcoholics. Peniston, EG., Kulkosky, PJ.[2022]

A controlled case study involving a recovering alcoholic patient showed that EEG alpha and theta brainwave training, combined with thermal biofeedback, led to improved central nervous system relaxation and reduced autonomic activation during stress after six training sessions.

Post-treatment evaluations indicated that the patient no longer experienced cravings for alcohol and functioned more relaxed under stress, suggesting that this brainwave training could be an effective intervention for preventing relapse in abstinent alcoholics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in EEG amplitude, personality factors, and brain electrical mapping after alpha-theta brainwave training: a controlled case study of an alcoholic in recovery. Fahrion, SL., Walters, ED., Coyne, L., et al.[2019]

Neurofeedback (NF) training significantly improved comorbid neuro-psychological symptoms in 20 opioid-dependent patients undergoing pharmacotherapy, as shown by reductions in scores on the Symptom Checklist-90-Revised and Heroin Craving Questionnaire after 30 sessions of NF training.

The study demonstrated positive changes in brain activity, with improvements in specific EEG signals, indicating that NF can effectively address abnormalities associated with opioid dependence and highlights the value of neuropsychological interventions in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of neurofeedback training as a treatment for opioid-dependent patients. Arani, FD., Rostami, R., Nostratabadi, M.[2022]

In a study involving 30 patients with opioid use disorder, LORETA Z Score Neurofeedback (LZNFB) combined with Methadone Maintenance Treatment (MMT) significantly reduced opioid cravings more than cognitive rehabilitation combined with MMT, indicating its superior efficacy in managing cravings.

Both LZNFB and cognitive rehabilitation improved recovery assessment scores compared to MMT alone, suggesting that these non-medical treatments are effective and safe options for enhancing the quality of life in patients with opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing LORETA Z Score Neurofeedback and Cognitive Rehabilitation Regarding Their Effectiveness in Reducing Craving in Opioid Addicts. Faridi, A., Taremian, F., Thatcher, RW., et al.[2023]

EEG biofeedback, particularly alpha theta training, shows promise as an effective intervention for substance use disorders (SUD), especially when used alone for alcoholism or combined with other therapies for stimulant and mixed substance abuse.

The review suggests that EEG biofeedback can enhance therapy outcomes, indicating its potential as a complementary treatment in residential programs for SUD, although further research is needed to optimize its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG biofeedback as a treatment for substance use disorders: review, rating of efficacy, and recommendations for further research. Sokhadze, TM., Cannon, RL., Trudeau, DL.[2023]

In a study involving 95 participants with substance use disorders, both automated EEG biofeedback (AEB) and clinician-guided EEG biofeedback (CEB) significantly improved attention scores compared to a control group receiving additional therapy, indicating their effectiveness in enhancing attention deficits during recovery.

The improvements in attention were measured using the Test of Variables of Attention (TOVA), showing significant reductions in reaction time variability and errors, suggesting that EEG biofeedback can be a valuable tool in comprehensive substance abuse treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of an automated EEG biofeedback system for attention deficits in a substance use disorders residential treatment setting. Keith, JR., Rapgay, L., Theodore, D., et al.[2022]

Neurofeedback therapy, which uses real-time feedback on brainwaves to promote self-regulation, shows promise in treating psychiatric disorders, including alcohol dependence, with the potential for long-term benefits due to neural plasticity.

This therapy has minimal side effects, primarily limited to rare temporary headaches, and can produce therapeutic effects more quickly than traditional psychotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. Yamaguchi, T., Tazaki, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10985214/

Integrated use of biofeedback and neurofeedback techniques ... The integrated neurofeedback + biofeedback approach has been shown to be effective in improving several aspects of these conditions.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125001222

A systematic review on the role of EEG and fMRI ... EEG/fMRI-neurofeedback can improve addictive symptoms especially craving. EEG/fMRI-neurofeedback can be promising add-on therapies for substance use disorders.

3. researchgate.net researchgate.net/publication/239733955_Neurofeedback_An_Integrative_Treatment_of_Substance_Use_Disorders

Neurofeedback An Integrative Treatment of Substance Use ... LZNFB training is more effective than Cognitive Rehabilitation in decreasing of craving in addiction. opioids. Plain language summary ...

4. researchgate.net researchgate.net/publication/368708003_A_meta-analysis_of_neurofeedback_for_treating_substance_use_disorders

A meta‐analysis of neurofeedback for treating substance ... This meta‐analysis provides strong evidence for the efficacy of NFB in treating SUD while also highlighting the value of wholistic client care in SUD treatment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3650238/

Neurofeedback Training for Opiate Addiction - PubMed Central Neurofeedback was shown to decrease the craving to use substance and improve general mental health in opiate dependence patients.

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH Meditation and mindfulness practices usually are considered to have few risks. However, few studies have examined these practices for potentially harmful ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT04261504

Brain Mechanisms of Reducing Polysubstance Use ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829421

Mindfulness Training vs Recovery Support for Opioid Use, ... This randomized clinical trial examines the effect of mindfulness training in adults receiving buprenorphine for opioid use disorder on drug ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023061194

Factors influencing the effects of the mindfulness-based ... This article aims to provide the experiences of mindfulness treatments from the perspectives of patients with a history of substance abuse.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8527365/

Mindfulness‐based interventions for substance use disorders MBIs may slightly reduce days with substance use compared to other treatments, but evidence is uncertain for other outcomes and compared to no treatment.