Brain Training for Substance Use Disorders

Neurotype Inc.

Status

Enrolling

Conditions

Opioid Use Disorder

Treatments

Device: Bias Modification Biofeedback

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT06870110

R44DA059517-01 (U.S. NIH Grant/Contract)

Pro00071720

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

Details and patient eligibility

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.