Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis

• Status: Withdrawn
• Trial end date: 2050-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Sheppard Pratt Health System; University of California, Los Angeles
• Treatments: Cannabidiol; Epidiolex

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.