Brain Training for Opioid Use Disorder

Overseen By Scott Burwell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurotype Inc.

Disqualifiers: Pregnant, Neurological illness, Opioid use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game difficulty.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Bias Modification Biofeedback for opioid use disorder?

Research shows that neurofeedback, a component of Bias Modification Biofeedback, has been effective in reducing symptoms and cravings in opioid-dependent patients. Additionally, neurofeedback has shown benefits in improving impulsivity and attention deficits in individuals with substance use disorders, suggesting its potential usefulness in treating opioid use disorder. ^{1 2 3 4 5}

Is brain training for opioid use disorder safe for humans?

Neurofeedback, a type of brain training, has been used safely in studies with people who have substance use disorders, including those dependent on opioids. These studies did not report any major safety concerns, suggesting that this treatment is generally safe for humans. ^{1 2 4 6 7}

How does the Bias Modification Biofeedback treatment for opioid use disorder differ from other treatments?

Bias Modification Biofeedback is unique because it uses real-time feedback to help patients change their brain responses to drug-related cues, aiming to reduce cravings and prevent relapse. This approach is different from traditional treatments that often focus on medication or behavioral therapy alone, as it directly targets the brain's response patterns associated with addiction. ^{1 2 3 6 8}

Research Team

Justin Anker, PhD

Principal Investigator

University of Minnesota

Scott Burwell, PhD

Principal Investigator

Neurotype Inc.

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder (OUD) who are in treatment and can consent to follow-ups. Control participants must match an OUD patient by age and gender, have at least a 6th grade reading level, and no opioid or serious drug issues. Exclusions include pregnancy, inability to consent, poor vision for computer tasks, regular nicotine use within the past year, unwillingness to adjust hair for EEG headset application, or serious neurological conditions.

Inclusion Criteria

OUD patient participants: Able and willing to provide own contact information for follow-up visit(s)

Control participants: A minimum of a 6th grade reading level

OUD patient participants: A minimum of a 6th grade reading level

Exclusion Criteria

Control participants: Current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs

OUD patient participants: Refusal or inability to consent

OUD patient participants: Inability to see text and photos clearly on the computer display

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in neurofeedback games using EEG-based Attention Bias Modification to reduce cue-induced drug craving processes

4-6 weeks

Multiple sessions per week

Follow-up

Participants are monitored for changes in cue reactivity and opioid craving after treatment

4 weeks

Treatment Details

Interventions

• Bias Modification Biofeedback

Trial Overview The study tests brain training games that aim to redirect attention away from drugs towards natural scenes. Participants' performance is linked with an EEG system that adjusts game difficulty based on their brain activity feedback during gameplay.

Participant Groups

Group I: Biofeedback Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Neurotype Inc.

Lead Sponsor

Trials

1

Recruited

40+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

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]

A study involving 135 prescription opioid users showed that an 8-week cognitive intervention called Mindfulness-Oriented Recovery Enhancement (MORE) significantly reduced reactivity to opioid-related cues and improved responses to natural rewards.

The intervention led to increased positive feelings towards natural rewards, which were linked to decreased cravings for opioids, suggesting that MORE can effectively help restore healthy reward processing in individuals struggling with opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement remediates hedonic dysregulation in opioid users: Neural and affective evidence of target engagement. Garland, EL., Atchley, RM., Hanley, AW., et al.[2020]

In a pilot study involving 20 long-term abstinent cocaine and heroin addicts, neurofeedback (NFB) treatment led to significant improvements in impulsivity, anxiety, and depression symptoms compared to a sham control group.

The NFB-treated participants showed a moderate effect size in reducing impulsivity and related clinical symptoms, suggesting that NFB may be a promising intervention for managing impulsive behavior in substance-abuse recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of EEG-Neurofeedback on the Modulation of Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates: A Pilot Study. Corominas-Roso, M., Ibern, I., Capdevila, M., et al.[2021]

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]

Neuroimaging techniques like PET, (1)H MRS, and fMRI reveal that effective treatments for substance use disorders improve executive control networks and reduce limbic activation, which are crucial for managing cravings and enhancing cognitive control.

Medications such as naltrexone and behavioral treatments like cognitive bias modification show significant neural effects, indicating their potential as effective interventions for substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging the Effectiveness of Substance Use Disorder Treatments. Cabrera, EA., Wiers, CE., Lindgren, E., et al.[2023]

A study involving 28 individuals with opioid use disorder (OUD) and chronic pain found that a cognitive bias modification (CBM) task significantly reduced attentional bias towards opioid and pain cues, suggesting it may help in managing cravings and pain in OUD treatment.

Participants reported high feasibility and acceptability of the CBM task, attending 83.3% of sessions, indicating that integrating such cognitive tasks into regular medication for OUD could be beneficial for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating cognitive bias modification for pain and opioid cues into medication for opioid use disorder clinical care: Feasibility, acceptability, and preliminary results. MacLean, RR., Heapy, AA., Waters, AJ., et al.[2023]

In a study involving newly detoxified male opioid-dependent patients, the left amygdala was found to be significantly activated in response to drug cues, indicating its central role in eliciting craving for opioids.

The dorsal anterior cingulate showed increased activity after exposure to drug cues, suggesting it may help regulate craving levels as they decline, highlighting its potential role in craving control during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. Murphy, A., Lubman, DI., McKie, S., et al.[2022]

References

1. 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]

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

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

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

Mindfulness-Oriented Recovery Enhancement remediates hedonic dysregulation in opioid users: Neural and affective evidence of target engagement. [2020]

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

Benefits of EEG-Neurofeedback on the Modulation of Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates: A Pilot Study. [2021]

5. 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]

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

Neuroimaging the Effectiveness of Substance Use Disorder Treatments. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Integrating cognitive bias modification for pain and opioid cues into medication for opioid use disorder clinical care: Feasibility, acceptability, and preliminary results. [2023]

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

Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. [2022]