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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03333460
Eligibility Criteria:
Inclusion Criteria:
1. Current diagnosis of cocaine use disorder (from moderate to severe), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
2. Abstinence from cocaine for at least 48 hrs.
Exclusion Criteria:
1. Current DSM-5 diagnosis of substance and/or alcohol use disorders other than nicotine;
2. Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
3. Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
4. Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes;
5. Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures;
6. Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
7. For female patients: Pregnancy/breastfeeding.
8. Subjects who have contraindications to MRI. Some of the exclusions are:
1. Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
2. Unable to lie flat on the back for the expected length of the experiment (50 minutes).
3. Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
4. Uncomfortable being in a small space for the expected length of the experiment (50 minutes).
5. Non-removable body piercing or tattoo posing MRI risk
6. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03333460
Study Brief:
Protocol Section:
NCT03333460