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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia Spectrum Disorders, Cannabis Use

In brief

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.

Key facts

Study ID

NCT03883360

Run by

University of Maryland, Baltimore

People needed

0

Starts

2050-01-01

Expected to finish

2050-03-01

Last updated by the study team

2021-04-19

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Semel Institute for Neuroscience and Human Behavior — Los Angeles, California, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• Maryland Psychiatric Research Center — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.