EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications
Developing EEG Biomarkers for OUD Diagnostic, Prognostic, and Predictive Purposes
University of Illinois at Chicago
70 participants
Feb 4, 2025
OBSERVATIONAL
Conditions
Summary
The US is suffering from a national opioid epidemic characterized by significant costs, overdoses, and deaths. Conventional Opioid Use Disorder (OUD) treatments (i.e., pharmacological and psychosocial interventions) are characterized by limited or diminishing efficacy, ceiling effects, and/or serious side effects. The availability of validated OUD biomarkers would be a key step in the development and approval of better treatments. Ultimately, the scarcity of OUD biomarkers represents a significant unmet need in the fight against opioid addiction as recognized by NIDA and the FDA with their support for development of Medical Device Development Tools (MDDT) and biomarker tests for OUD. Advances in neuroimaging techniques, and in particular recent evidence supports electroencephalography (EEG) as a promising candidate to investigate the correlation between addiction and brain state. To address the clear medical and market need for OUD biomarkers, this is a feasibility study to identify and assess potential EEG biomarkers for OUD diagnoses, disease monitoring, and prediction of OUD treatment response.
Eligibility
Inclusion Criteria10
- For OUD Subjects:
- Providing informed consent to participate in the study.
- 22 to 85 years old.
- Having a diagnosis of OUD
- OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) \[71\] with a positive urine toxicology screen who still feel craving.
- \. Lives in immediate area with no plans to relocate.
- For age-matched controls:
- Providing informed consent to participate in the study.
- 22 to 85 years old.
- Lives in immediate area with no plans to relocate
Exclusion Criteria17
- For OUD Subjects:
- Recently started on antiepileptic drug therapy.
- Ingestion of poppy seeds or herbal teas containing Papaveris fructus (may cause a positive opiate test for morphine, codeine \[72,73\]).
- History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported.
- History of unexplained fainting spells as self-reported.
- History of head injury resulting in more than a momentary loss of consciousness as self-reported.
- History of brain surgery as self-reported.
- Suffering from severe depression.
- Active malignancy.
- For age-matched controls:
- Recently started on antiepileptic drug therapy.
- History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported.
- History of unexplained fainting spells as self-reported.
- History of head injury resulting in more than a momentary loss of consciousness as self-reported.
- History of brain surgery as self-reported.
- Suffering from severe depression.
- Active malignancy.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07085351