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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03681769
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 75 (to maximize participation)
* Currently using prescription opiates
* Able to read and understand questionnaires and informed consent.
* Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
* Does not have metal objects in the head/neck.
* Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
* Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
Exclusion Criteria:
* Any psychoactive illicit substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine Carboxy-Tetrahydrocannabinol levels.
* Meets Diagnostic and Statistical Manual of Mental Disorders IV criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
* Has current suicidal ideation or homicidal ideation.
* Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for Attention Deficit Hyperactivity Disorder.
* Females of childbearing potential who are pregnant (by urine human chorionic gonadotropin level), nursing, or who are not using a reliable form of birth control.
* Has current charges pending for a violent crime (not including driving under the influence related offenses).
* Does not have a stable living situation.
* Suffers from chronic migraines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03681769
Study Brief:
Protocol Section:
NCT03681769