Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04411225
Phase
PHASE3
Status
Recruiting
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Conditions

  • Early Psychosis

Eligibility Criteria

Sex
ALL
Age
16 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol oral solution — DRUG
    Both the active drug (cannabidiol) and placebo will be in oral solution.

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cannabidiol Augmentation
    The cannabidiol will be administered as an oral solution to be mixed in any fluid. The formulation is 100 mg/ml. It will be administered at 500 mg at bedtime X 1 week then 500 mg BID.
  • Placebo Comparator: Placebo Augmentation
    Placebo will appear identical to the cannabidiol solution

Primary Outcome Measure

Positive and Negative Symptoms of Psychosis [ Time Frame: Week 7 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093
Kristin Cadenhead, MD
[email protected]
619-543-6445
Heline Mirzakhanian, PhD
[email protected]
619-543-7745
University of California, San DiegoSan DiegoCalifornia92093
Tracy Alderman, PhD
[email protected]
619 543-7761
Kristin S Cadenhead, MD (PRINCIPAL_INVESTIGATOR)

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