Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT07085351
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT07085351
Study Brief:
Protocol Section:
NCT07085351