Clinical Trials in the USA / NCT06870110
Recruiting
Not applicable
Brain Training for Substance Use Disorders
NCT06870110 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Opioid Use Disorder
Investigational drug(s) / intervention(s)
Bias Modification Biofeedback
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.
Study 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.
Eligibility
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 outcome measure(s)
- Change in ERP-Based Classification of Opioid-Related Attention Bias (Probability Score) — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Minnesota - Department of Psychiatry & Behavioral Health | Minneapolis | Minnesota | Recruiting |
Other trials for the same condition
Remotely Observed Methadone Evaluation II
Recruiting
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
Active, not recruiting
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06870110 on ClinicalTrials.gov ↗ ← All trials in the USA