Opiod Use DisorderNCT07085351
EEG Biomarkers for OUD: Diagnostic, Prognostic, and Predictive Applications
An observational study of Opiod Use Disorder, run by University of Illinois Chicago at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiod Use Disorder
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Feb 2025to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 4. Lives in immediate area with no plans to relocate.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
Cambridge, Massachusetts, 02138
Clinical & Imaging Research Outcomes Lab
Chicago, Illinois, 60612
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
About this study
Official title: Developing EEG Biomarkers for OUD Diagnostic, Prognostic, and Predictive Purposes
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.
Read the detailed description
We will recruit up to 130 subjects for this study, with the intention of enrolling 50 OUD subjects at various stages of treatment and 20 age-matched non-OUD controls.
Eligible subjects will contact or give verbal permission to be contacted via their referring provider, by a co-investigator to obtain more information about the study. At the first point of contact (usually a phone call), study co- investigator will administer a phone-screening questionnaire. Once the phone screening process is complete, the information gathered by the co-investigator will be taken to the PI of the study for further review to confirm eligibility. Data obtained from screening will be safely stored in the PI's locked office.
Informed consent will be obtained by the study PI and/or a co-investigator (not involved in the patient's care) in person. The test procedures will be described and the testing equipment will be shown to the subject. Study co-investigators will clearly explain all the procedures and risks of the testing outlined in the consent form. The subject will be given the time needed to consider their decision and will be encouraged to ask questions, both during the initial phone interview and throughout the study. The PI or a co-investigator will answer any questions regarding the study at the time consent is given. Once enrolled, the subject may pause or terminate his/her participation at any time during the study.
Procedures Involved* This is an observational study that includes an EEG at rest and also an EEG conducted while the subject is simultaneously completing a computer assessment. The study will have 50 OUD patients and 20 age-matched controls. Subjects will undergo EEG testing in addition to testing done concurrently with computer assessments. An additional visit will be conducted around 1 week after the initial visit. Additionally, subjects will undergo questionnaires/assessments regarding demographics, HPI, craving, mood, impulsivity, and drug use. Urine toxicology and Hair follicle (when available) will also be conducted.
- Conditions
- Opiod Use Disorder
- Keywords
- opioid use disorder, EEG
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram power in Delta through Gamma bands
High-density electroencephalogram power will be assessed during rest (eyes open, eyes closed) and activity
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start4 Feb 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiod Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ciro Ramos Estebanez, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085351
- Sponsor's protocol ID
- STUDY2023-1092
- Other IDs
- R43DA058979
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing EEG Biomarkers for OUD Diagnostic, Prognostic, and Predictive Purposes
- ClinicalTrials.gov ID
- NCT07085351
- Acronym / sponsor ID
- STUDY2023-1092
- Conditions
- Opiod Use Disorder
- Keywords
- opioid use disorder, EEG
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will recruit up to 130 subjects for this study, with the intention of enrolling 50 OUD subjects at various stages of treatment and 20 age-matched non-OUD controls.
Eligible subjects will contact or give verbal permission to be contacted via their referring provider, by a co-investigator to obtain more information about the study. At the first point of contact (usually a phone call), study co- investigator will administer a phone-screening questionnaire. Once the phone screening process is complete, the information gathered by the co-investigator will be taken to the PI of the study for further review to confirm eligibility. Data obtained from screening will be safely stored in the PI's locked office.
Informed consent will be obtained by the study PI and/or a co-investigator (not involved in the patient's care) in person. The test procedures will be described and the testing equipment will be shown to the subject. Study co-investigators will clearly explain all the procedures and risks of the testing outlined in the consent form. The subject will be given the time needed to consider their decision and will be encouraged to ask questions, both during the initial phone interview and throughout the study. The PI or a co-investigator will answer any questions regarding the study at the time consent is given. Once enrolled, the subject may pause or terminate his/her participation at any time during the study.
Procedures Involved* This is an observational study that includes an EEG at rest and also an EEG conducted while the subject is simultaneously completing a computer assessment. The study will have 50 OUD patients and 20 age-matched controls. Subjects will undergo EEG testing in addition to testing done concurrently with computer assessments. An additional visit will be conducted around 1 week after the initial visit. Additionally, subjects will undergo questionnaires/assessments regarding demographics, HPI, craving, mood, impulsivity, and drug use. Urine toxicology and Hair follicle (when available) will also be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- For OUD Subjects:
- 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.
- Providing informed consent to participate in the study.
Key exclusion criteria (17 listed)
- For OUD Subjects:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electroencephalogram power in Delta through Gamma bands
Time frame: 1 week
High-density electroencephalogram power will be assessed during rest (eyes open, eyes closed) and activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiod Use Disorder, run by University of Illinois Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram power in Delta through Gamma bands (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.