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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03883360
Eligibility Criteria:
Inclusion Criteria:
* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, and other specified or unspecified schizophrenia spectrum and other psychotic disorder.
* Experienced a first psychotic episode within the last 5 years.
* Self-reported cannabis use at least twice/week for at least the last 4 weeks.
* THCCOOH serum levels of ≥ 5 ng/mL.
* Total score ≥45 on the 18-item version of the Brief Psychiatric Rating Scale.
* Able to give written informed consent.
* Normal or corrected to normal vision.
* If medicated, no change in psychiatric medication within the preceding 4 weeks, with no foreseeable changes.
Exclusion Criteria:
* DSM-5 diagnosis of Substance Use Disorder other that cannabis or nicotine within the last year (recreational use is not exclusionary).
* Currently undergoing active treatment for Cannabis Use Disorder other than low-level (once/week or less) psychosocial intervention.
* Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg).
* Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval \<120 ms or \>200 ms, Prolonged QT interval (corrected) \>500 ms, Cardiac arrhythmias as defined by PACs \>3 per min or PVCs \>1 per min).
* History of or current neurological illness, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
* Intellectual disability.
* Pregnant or lactating.
* Diabetes.
* Significant kidney or liver impairment.
* Any chronic or severe infectious disease, including HIV and hepatitis.
* Cancer.
* Use of any barbiturates, diazepam, diltiazem, verapamil, protease inhibitors, any anticonvulsant medications (including valproate/valproic acid, lamotrigine, carbamazepine, and clobazam), glipizide, glyburide, warfarin, and cyclophosphamide/ ifosfamide, due to potential interaction with CBD at the metabolic level.
* Suicidal ideation currently or within last 6 months (score of \>/= 3 on the Columbia Suicide Severity Rating Scale).
* Less than the lower limit of normal hemoglobin and hematocrit at screening.
* Elevated transaminase levels \>3 times the ULN, accompanied by elevations in bilirubin \>2 times the ULN.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03883360
Study Brief:
Protocol Section:
NCT03883360