NCT06870110 · Neurotype Inc.
Brain Training for Substance Use Disorders
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Bias Modification Biofeedback
The device uses EEG-based bias modification biofeedback intended to reduce attention to drug-related cues and increase attention to non-drug pleasant scenes. Specifically, the device measures perceptual biases from Event-Related Potential biomarkers related to Substance Use Disorders.
Primary outcome measures
Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score)
Time frame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
The primary outcome will be the change in ERP-based classification scores (probability values) reflecting opioid-related attention bias. ERP voltages from all electrodes will be classified with coefficients reflecting increased amplitude in Early Posterior Negativity (150 to 300 ms), P300 complex (250 to 450 ms), and Late Positive Potential (400 to 900 ms) windows. Change in classification score from the last minus first block will be evaluated.
Change in Visual Probe Task Reaction Time (milliseconds) to Drug-Related Stimuli
Time frame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
The primary outcome will be the change in reaction time (milliseconds) on the Visual Probe Task, measuring attention bias toward drug-related versus neutral stimuli. Participants will complete the task before and after the biofeedback session. Attention bias is indicated by differences in reaction time when responding to probes replacing drug-related versus neutral stimuli. Improvement is reflected by reduced bias scores, calculated as the difference between reaction times to drug-related versus neutral probes. Change scores from pre- to post-session will be analyzed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- OUD patient participants:
- Admitted into chemical treatment with opioid use being a reason for treatment;
- DSM-IV-TR diagnosis of OUD;
- Ability to provide informed consent;
- A minimum of a 6th grade reading level; and
- Able and willing to provide own contact information for follow-up visit(s). Control participants:
- Age- and gender-matched to an OUD patient participant in the study;
- Ability to provide informed consent;
- A minimum of a 6th grade reading level;
- Able and willing to provide own contact information for follow-up visit(s).
Exclusion criteria
- OUD patient participants:
- Refusal or inability to consent;
- History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures not caused by withdrawal from substances, Other \[please specify\]);
- Inability to see text and photos clearly on the computer display; and
- Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary. Control participants:
- Refusal or inability to consent;
- History of serious neurological illness (e.g., Chronic seizure disorder, Wernicke-Korsakoff Syndrome, Epilepsy, Any history of seizures, Other \[please specify\]);
- Inability to see text and photos clearly on the computer display;
- Current or previous problems using opioids, other prescription (prescribed or not prescribed) or illicit drugs;
- Regular nicotine user (e.g., cigarette smoker, e-cig user) within the past 12 months; and
- Unwillingness to change hairstyle (e.g., braids, pony tails, dreadlocks) or remove wig to accommodate application of the EEG headset, if necessary.
Where
- Minneapolis, Minnesota
Collaborators
University of Minnesota, National Institute on Drug Abuse (NIDA)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2025 · Source of record for eligibility and locations