NCT04411225

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

Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 16 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants will be randomly assigned in a 1:1 ratio to receive CBD or matching Placebo as an add-on to antipsychotic medication in an 8 week double blind trial. In this study, Cannabidiol Oral Solution (CBD) product will be used. This product is manufactured and supplied by GW Pharmaceuticals. The formulation is a 100 mg/mL solution. The CBD compound will be dosed at 1000mg/day administered in two divided doses. The dose of CBD was selected based on previous controlled trials that demonstrate the efficacy of CBD in patients with schizophrenia. The maximum duration of the study from screening to follow up of outcomes and adverse events will be approximately 8 weeks. Participants will receive either the CBD or placebo within this eight.weeks and will also complete pre-treatment, midpoint (week 4) and post-treatment testing (week 8).

Conditions

• Early Psychosis

Interventions

Type	Name	Description
DRUG	Cannabidiol oral solution	Both the active drug (cannabidiol) and placebo will be in oral solution.

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-06-02
• Last updated: 2026-01-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study