Cannabidiol versus placebo as adjunctive treatment in early psychosis: study protocol for randomized controlled trial.
T Dixon, K S Cadenhead
https://pubmed.ncbi.nlm.nih.gov/38037108Actively Recruiting
Phase 3
Age: 16Years - 30Years
All Genders
ID04411225
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action
Led by University of California, San Diego · Updated on 2026-01-08
120
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the use of Cannabidiol (CBD) as an add-on treatment for adolescents and young adults with early psychosis. This study is a double-blind, placebo-controlled trial comparing CBD with a matching placebo. The goal is to see if CBD can improve symptoms, thinking abilities, inflammation markers, and eating behaviors in patients who have experienced their first episode of psychosis within the last two years or have attenuated psychosis syndrome. Participants will be randomly assigned to receive either CBD oral solution or placebo for 8 weeks alongside their usual antipsychotic medication. The CBD is given as a 100 mg/mL oral solution dosed at 1000 mg per day, split into two doses. The first week includes 500 mg at bedtime, followed by 500 mg twice daily. The placebo looks identical to the CBD solution. Testing occurs before treatment, at week 4, and after 8 weeks of treatment. During the study, participants will complete evaluations of psychosis symptoms, cognitive function, and general health status at week 7. Researchers will also measure markers of inflammation and cortisol levels. The whole study from screening to follow-up lasts about 8 weeks, with careful monitoring for any side effects or changes. This study is sponsored by the University of California, San Diego.
CONDITIONS
Brief Title
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
Who Can Participate
Age: 16Years - 30Years
All Genders
Eligibility Criteria
You may qualify if you...
- First episode psychosis onset within the last 2 years or attenuated psychosis syndrome, stabilized with treatment for at least 8 weeks
- Clinically stable and in a nonacute phase for at least 2 months
- First episode psychosis participants maintained on current antipsychotic for at least 6 weeks with no dose changes for 4 weeks
- APS participants on stable psychosocial or pharmacologic treatment for 4 weeks
- Moderate or less severe positive symptoms on PANSS scale (ratings \u2264 4 on specified items)
- Minimal depressive symptoms by Calgary Depression Scale for Schizophrenia
- Diagnoses include APS, Psychosis NOS, Schizophreniform, Schizophrenia, and Schizoaffective per DSM-V structured interview
You will not qualify if you...
- Concomitant medical or neurological illnesses
- Significant head injury
- Impaired intellectual functioning IQ less than 80 (except IQ 75-79 with WRAT reading > 85)
- High suicidal risk per Columbia-Suicide Severity Rating Scale
- Pregnant women or unwilling to avoid pregnancy
- Patients requiring treatment with Azelastine, Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 8 weeks
Participants receive either cannabidiol oral solution or placebo as an add-on to antipsychotic medication.
1 baseline visit, 1 midpoint visit at week 4, and 1 post-treatment visit at week 8
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
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Research Team
K
Kristin Cadenhead
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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