RecruitingPhase 3NCT04411225

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


Sponsor

University of California, San Diego

Enrollment

120 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether cannabidiol (CBD), a non-intoxicating compound from cannabis, can improve thinking, mood, or overall wellbeing when added to existing treatment for people in the early stages of psychosis (a condition involving breaks from reality such as hallucinations or delusions). **You may be eligible if...** - You have had your first episode of psychosis within the last 2 years, or you have early warning signs of psychosis (attenuated psychosis syndrome) - Your symptoms have been stable for at least 2 months - You have mild to moderate positive symptoms (e.g., not severely psychotic) - You have been on the same medication or treatment plan for at least 4–6 weeks **You may NOT be eligible if...** - You have another neurological or medical illness - You have a significant history of head injury - Your IQ is below 80 - You have a high risk of suicide - You are currently using cannabis or other substances Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCannabidiol oral solution

Both the active drug (cannabidiol) and placebo will be in oral solution.


Locations(2)

UC San Diego

La Jolla, California, United States

University of California, San Diego

San Diego, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04411225


Related Trials