Recruiting

EEG Biomarkers

Sponsor:

University of Illinois at Chicago

Code:

NCT07085351

Conditions

Opiod Use Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07085351

Start date

Feb 4, 2025

Status verified date

Jul, 2025

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • For OUD Subjects:

1. Providing informed consent to participate in the study.
2. 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.

4\. Lives in immediate area with no plans to relocate.

For age-matched controls:

1. Providing informed consent to participate in the study.
2. 22 to 85 years old.
3. Lives in immediate area with no plans to relocate

Exclusion Criteria:

  • For OUD Subjects:

1. Recently started on antiepileptic drug therapy.
2. Ingestion of poppy seeds or herbal teas containing Papaveris fructus (may cause a positive opiate test for morphine, codeine \[72,73\]).
3. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported.
4. History of unexplained fainting spells as self-reported.
5. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
6. History of brain surgery as self-reported.
7. Suffering from severe depression.
8. Active malignancy.

For age-matched controls:

1. Recently started on antiepileptic drug therapy.
2. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported.
3. History of unexplained fainting spells as self-reported.
4. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
5. History of brain surgery as self-reported.
6. Suffering from severe depression.
7. Active malignancy.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Electroencephalogram power in Delta through Gamma bands [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Aksarapak Hengyotmark, MD

312-257-4158ahengy2@uic.edu

Locations

Clinical & Imaging Research Outcomes Lab

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Aksarapak Hengyotmark, MD

312-257-4158ahengy2@uic.edu

Principal Investigator:

Ciro Ramos-Estebanez, MD., Ph.D.

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • opioid use disorder
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-07-25.