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

Trial Summary

What is the purpose of this trial?

The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.

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.

What data supports the effectiveness of this treatment for substance abuse?

Research shows that EEG biofeedback, a part of this treatment, has been effective in reducing symptoms of depression and preventing relapse in alcoholics. It also improved attention in individuals with substance use disorders, suggesting potential benefits for substance abuse recovery. ^{1 2 3 4 5}

Is neurofeedback and body-mind training safe for humans?

Research on neurofeedback and body-mind training, including techniques like EEG biofeedback and alpha-theta brainwave training, suggests they are generally safe for humans. Studies have shown these methods can help with stress reduction and relaxation without significant adverse effects. ^{1 4 6 7 8}

How does the Neurofeedback + Body-Mind Training treatment for substance abuse differ from other treatments?

This treatment is unique because it combines neurofeedback, which helps individuals learn to control their brainwaves, with body-mind training techniques like mindfulness, aiming to improve self-regulation and reduce cravings without significant side effects. Unlike traditional drug therapies, it focuses on enhancing brain function and promoting long-term changes through neural plasticity. ^{1 7 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

EEG biofeedback as a treatment for substance use disorders: review, rating of efficacy, and recommendations for further research. [2023]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Effects of an EEG biofeedback protocol on a mixed substance abusing population. [2022]

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

An assessment of an automated EEG biofeedback system for attention deficits in a substance use disorders residential treatment setting. [2022]

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

EEG-neurofeedback and psychodynamic psychotherapy in a case of adolescent anhedonia with substance misuse: mood/theta relations. [2022]

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

Beta/theta ratio neurofeedback training effects on the spectral topography of EEG. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Alpha-theta brainwave training and beta-endorphin levels in alcoholics. [2022]

8. England 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. [2019]

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

Effectiveness of neurofeedback training as a treatment for opioid-dependent patients. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

Comparing LORETA Z Score Neurofeedback and Cognitive Rehabilitation Regarding Their Effectiveness in Reducing Craving in Opioid Addicts. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. [2019]