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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with opioid use disorder (OUD) through a game that trains the brain to focus on non-drug-related scenes. The game, called Bias Modification Biofeedback, adjusts its difficulty based on brain activity monitored by an EEG, which measures electrical activity in the brain. The researchers aim to determine if this method can reduce cravings and improve attention. Individuals currently in treatment for opioid use and who can read at a 6th-grade level might be suitable candidates. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could lead to new treatment methods for OUD.

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 prior data suggests that this protocol is safe for participants?

Research has shown that EEG neurofeedback therapy, similar to the biofeedback used in this trial, effectively reduces addiction symptoms, particularly for substance addiction. This suggests that Bias Modification Biofeedback might be safe.

Additionally, studies on similar technologies, such as virtual reality-based mindfulness therapies, have found them easy to use and accept, with a strong safety record. Although these studies do not exactly match the biofeedback method being tested, they provide reassurance about safety.

However, since this trial remains in an early phase and all safety details are not fully known, participants should consult the trial team to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for opioid use disorder involve medications like methadone, buprenorphine, or naltrexone that target the brain's opioid receptors to reduce cravings and withdrawal symptoms. But Bias Modification Biofeedback takes a different approach by focusing on retraining the brain's responses to opioid-related cues. This technique aims to alter subconscious biases and reduce the automatic attention given to drug-related stimuli, potentially leading to fewer cravings and better self-control. Researchers are excited about this method because it offers a non-pharmacological option that could complement existing treatments, providing a holistic approach to managing addiction.

What evidence suggests that Bias Modification Biofeedback might be an effective treatment for opioid use disorder?

Studies have shown that bias modification biofeedback, which participants in this trial will receive, can aid individuals with opioid use disorder (OUD). Research suggests it improves focus and reduces drug cravings. One study found that biofeedback also lowered anxiety and depression, common in those dealing with addiction. Additionally, neurofeedback and attention bias training have enhanced quality of life and self-control for OUD patients. While more research is always beneficial, these early findings offer promise for those considering this treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Justin Anker, PhD

Principal Investigator

University of Minnesota

Scott Burwell, PhD

Principal Investigator

Neurotype Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189744/

Integrating cognitive bias modification for pain and opioid ... The current study evaluated the feasibility, acceptability, and preliminary efficacy of the CBM task.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/0376871682900564

Biofeedback treatment of narcotic addiction: A double-blind ... All the psychiatric ratings of anxiety, depression, psychopathology were significantly reduced. In addition, self-rated craving for narcotics and self-rated ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15500594241283069

Comparative Analysis of LORETA Z Score Neurofeedback ... Both LZNFB and attention bias modification training are effective in improving quality of life and response inhibition of men with OUD under MMT ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2833307

Positive Emotion Dysregulation in Opioid Use Disorder and ... This study tests whether opioid use disorder (OUD) is associated with attenuated positive emotion regulation and whether such positive ...

5. researchgate.net researchgate.net/publication/45718746_Effectiveness_of_Neurofeedback_Training_as_a_Treatment_for_Opioid-Dependent_Patients

Effectiveness of Neurofeedback Training as a Treatment for ... In this regard, previous studies have shown that NFB decreased the craving for METH (Hashemian, 2015) and opioid use (Arani et al., 2010) , and ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2024.2392870

Full article: Virtual reality-based Mindfulness-Oriented ... Participants reported high usability and acceptability of MORE-VR, which had an excellent safety profile. Illicit opioid use decreased ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70164

Effect of EEG neurofeedback therapy on addiction disorders EEG-NF statistically significantly alleviated addiction symptoms (Hedges'g = 0.85, P < 0.001), with stronger effects on substance addiction than ...

8. researchgate.net researchgate.net/publication/384040022_Comparative_Analysis_of_LORETA_Z_Score_Neurofeedback_and_Cognitive_Rehabilitation_on_Quality_of_Life_and_Response_Inhibition_in_Individuals_with_Opioid_Addiction

Comparative Analysis of LORETA Z Score Neurofeedback ... Previous studies has shown that conventional neurofeedback and cognitive rehabilitation can improve psychological outcomes in people with opioid ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342816/

Virtual reality-based Mindfulness-Oriented Recovery ... Participants reported high usability and acceptability of MORE-VR, which had an excellent safety profile. Illicit opioid use decreased ...