EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications

NCT07085351 | Recruiting

• 2 other identifiers: STUDY2023-1092R43DA058979
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opiod Use Disorder

Keywords

opioid use disorder; EEG

Outcome Measures

Primary Outcomes (1)

• Electroencephalogram power in Delta through Gamma bands

  High-density electroencephalogram power will be assessed during rest (eyes open, eyes closed) and activity

  1 week

Study Arms (2)

Opioid Use Disorder

Diagnosed Opioid Use Disorder subjects will perform 2 EEG sessions done at the initial visit and one week later. EEG recordings will be taken to monitor brain activity

Healthy Control

Age-matched healthy controls. Subjects will perform 2 EEG sessions done at the initial visit and one week later. EEG recordings will be taken to monitor brain activity

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 22-85 years who live locally and consent will be enrolled in two groups: an OUD cohort (DSM-5 opioid use disorder ≥6 months, positive urine toxicology, ongoing craving) and an age-matched non-OUD control group. All must reside in the study area with no relocation plans. Exclusion criteria (both cohorts) include recent antiepileptic initiation; history of stroke, brain tumor, epilepsy, unexplained syncope, significant head injury with loss of consciousness, or brain surgery; severe depression; active malignancy; and, for OUD subjects, recent ingestion of poppy seeds or Papaveris fructus products.

You may qualify if:

• For OUD Subjects:
• Providing informed consent to participate in the study.
• 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.
• to 85 years old.
• Lives in immediate area with no plans to relocate

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Clinical & Imaging Research Outcomes Lab

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Aksarapak Hengyotmark, MD

CONTACT

312-257-4158; ahengy2@uic.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 25, 2025
• Study Start: February 4, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)