Clinical trial NCT06870110: Brain Training for Substance Use Disorders
Official title: Brain Training for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: biofeedback
neurofeedback
electroencephalogram
addiction
substance use disorder
opioid use disorder
attention
emotion regulation
event-related potential
Lead sponsor: Neurotype Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score)
timeFrame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
measure: Change in Visual Probe Task Reaction Time (milliseconds) to Drug-Related Stimuli
timeFrame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
Secondary outcomes:
measure: Change in Rating of Cue Reactivity (1-5 Likert Scale)
timeFrame: Pre- to post-biofeedback for a given scene (same day, approximately 30 seconds)
measure: Change in Visual Analog Scale (VAS) Rating of Instantaneous Opioid Craving (1-100)
timeFrame: Pre- to post-biofeedback session (same day, approximately 30 minutes)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota - Department of Psychiatry & Behavioral Health
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Justin Anker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurotype Inc.
name: Scott Burwell, PhD
role: STUDY_DIRECTOR
References: