Actively Recruiting
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
Led by University of California, San Diego · Updated on 2026-01-08
120
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
C
Center for Medicinal Cannabis Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks. The study will examine CBD as an augmentation strategy in early psychosis. It is hypothesized that CBD will improve symptoms, neurocognition, markers of inflammation and eating behaviors. Importantly, moderators and mediators of the CBD effects will be explored.
CONDITIONS
Official Title
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First episode psychosis onset within the last 2 years or attenuated psychosis syndrome (APS), stabilized with treatment for at least 8 weeks prior to the trial
- Clinically stable and in a nonacute phase of illness for at least 2 months
- First episode psychosis patients maintained on current antipsychotic for at least 6 weeks with no dose change in previous 4 weeks
- APS participants on the same treatment regimen for at least 4 weeks
- Moderate or less positive symptoms (PANSS items P1, P2, P3, P5, P6, G8 scores 4)
- Minimal depressive symptoms as measured by the Calgary Depression Scale for Schizophrenia
- Diagnoses including APS, Psychosis NOS, Schizophreniform, Schizophrenia, or Schizoaffective per DSM-V structured interview
You will not qualify if you...
- Presence of concomitant medical or neurological illness
- Significant head injury
- Intellectual functioning IQ below 80, except those with IQ 75-79 if WRAT reading > 85
- High suicidal risk assessed by the Columbia-Suicide Severity Rating Scale
- Pregnant women or those unwilling to avoid pregnancy
- Patients requiring treatment with Azelastine, Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UC San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
K
Kristin Cadenhead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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