Opioid Use DisorderNCT06870110
Brain Training for Substance Use Disorders
A study testing Bias Modification Biofeedback in people with Opioid Use Disorder, run by Neurotype Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Bias Modification Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota - Department of Psychiatry & Behavioral Health
Minneapolis, Minnesota, 55454
Scott Burwell, PhD, 612-790-9304, burwell@umn.edu
Justin Anker, PhD, 612-273-9819, anke0022@umn.edu
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Bias Modification Biofeedback
- Keywords
- biofeedback, neurofeedback, electroencephalogram, addiction, substance use disorder, opioid use disorder, attention, emotion regulation, event-related potential
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Substance-Related Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bias Modification BiofeedbackDevice
Also called Modit™, Modit-O™, Modit-AB™
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Not described Receives: Device: Bias Modification Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score)
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.
Measured: Pre- to post-biofeedback session (same day, approximately 30 minutes)
Change in Visual Probe Task Reaction Time (milliseconds) to Drug-Related Stimuli
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.
Measured: Pre- to post-biofeedback session (same day, approximately 30 minutes)
Secondary outcomes (2)
Change in Rating of Cue Reactivity (1-5 Likert Scale)
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.
Measured: 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)
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.
Measured: Pre- to post-biofeedback session (same day, approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start17 Jan 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotype Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Justin Anker, PhD, Principal investigator, University of MinnesotaScott Burwell, PhD, Study director, Neurotype Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870110
- Sponsor's protocol ID
- Pro00071720
- Other IDs
- R43DA057773-01A1, R44DA059517-01
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: De-identified data may be shared upon request based on decision of study leadership.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Training for Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06870110
- Acronym / sponsor ID
- Pro00071720
- Conditions
- Opioid Use Disorder
- Keywords
- biofeedback, neurofeedback, electroencephalogram, addiction, substance use disorder, opioid use disorder, attention, emotion regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neurotype Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, National Institute on Drug Abuse (NIDA)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Device: Bias Modification Biofeedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bias Modification BiofeedbackAlso: Modit™, Modit-O™, Modit-AB™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. | Device | Biofeedback |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided. De-identified data may be shared upon request based on decision of study leadership.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Anker, PhD principal investigator
University of Minnesota
Scott Burwell, PhD study director
Neurotype Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bias Modification Biofeedback in people with Opioid Use Disorder, run by Neurotype Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Burwell, PhD (612-790-9304, burwell@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.