Brain Training for Substance Use Disorders

March 5, 2025 updated by: Neurotype Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this project is to gather pilot data on neurofeedback games that use electroencephalogram (EEG)-based Attention Bias Modification (ABM) to reduce cue-induced drug craving processes in individuals with Opioid Use Disorder (OUD). The project will involve the use of three empirically-supported and potentially therapeutic games that include drug- (such as pill bottle and syringe) and non-drug-related stimuli (such as food and smiling faces). An EEG system will be used to monitor brain activity during gameplay.

The neurofeedback loop for attention training will be synchronized to cue presentations using EEGs which monitor visual Event-Related Potentials (ERP) signatures of attention. The degree of difficulty (i.e., cue content) on subsequent trials of the game will be determined based on the level of attention measured in the neurofeedback loop.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Scott Burwell, PhD
  • Phone Number: 612-790-9304
  • Email: burwell@umn.edu

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota - Department of Psychiatry & Behavioral Health
        • Contact:
        • Contact:
        • Contact:
          • Justin Anker, PhD
        • Contact:
          • Scott Burwell, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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;
  • Pregnant;
  • 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;
  • Pregnant;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback
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.
Other Names:
  • Modit™
  • Modit-O™
  • Modit-AB™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre- to post-biofeedback session (same day, approximately 30 minutes)
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.
Pre- to post-biofeedback session (same day, approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rating of Cue Reactivity (1-5 Likert Scale)
Time Frame: Pre- to post-biofeedback for a given scene (same day, approximately 30 seconds)
The outcome will be the change in self-reported cue reactivity, measured with a Likert scale ranging from 1 (not at all) to 5 (extremely). Participants rate their cue reactivity before and after each series of images being presented for a given scene. The average change in cue reactivity across all scenes during the 30-minute biofeedback protocol will be quantified for each session.
Pre- to post-biofeedback for a given scene (same day, approximately 30 seconds)
Change in Visual Analog Scale (VAS) Rating of Instantaneous Opioid Craving (1-100)
Time Frame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
The outcome will be the change in self-reported instantaneous ("right now") opioid craving, measured with a Visual Analog Scale (VAS) ranging from 1 ("No Drug Craving") to 100 ("Extreme Drug Craving"). Participants will rate their current craving before and after the biofeedback session. Change scores from pre- to post-session will be analyzed.
Pre- to post-biofeedback session (same day, approximately 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurotype Inc.

Collaborators

National Institute on Drug Abuse (NIDA)
University of Minnesota

Investigators

  • Principal Investigator: Justin Anker, PhD, University of Minnesota
  • Study Director: Scott Burwell, PhD, Neurotype Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00071720
  • R43DA057773-01A1 (U.S. NIH Grant/Contract)
  • R44DA059517-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified data may be shared upon request based on decision of study leadership.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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