EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications (NCT07085351) | Clinical Trial Compass
RecruitingNot Applicable
EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications
United States70 participantsStarted 2025-02-04
Plain-language 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.
Who can participate
Age range22 Years – 85 Years
SexALL
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Inclusion criteria
✓. Providing informed consent to participate in the study.
✓. 22 to 85 years old.
✓. Providing informed consent to participate in the study.
✓. 22 to 85 years old.
✓. Lives in immediate area with no plans to relocate
Exclusion criteria
✕. 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.
What they're measuring
1
Electroencephalogram power in Delta through Gamma bands