NCT04086342

CHI-902 for Treatment of Social Anxiety Disorder

CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Canopy Growth Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD. In addition, the effects of treatment with CHI-902 on the Endocannabinoid System (ECS) will be assessed by evaluating peripheral endocannabinoids (Arachidonoylethanolamide/Anandamide (AEA) and 2-Arachidonoyl glycerol (2-AG)) before and after treatment.

Detailed description

This study will evaluate efficacy, therapeutic effects, tolerability and safety of CBD oil in adults with SAD through a randomized placebo-controlled study design and will evaluate effects of CHI-902 on peripheral endocannabinoids (AEA and 2-AG). This study will be the first randomized, double-blind placebo-controlled trial conducted with CHI-902 in adults with SAD. The study is designed to: * Evaluate the efficacy of CHI-902 versus placebo in adults with SAD. * Evaluate the tolerability and safety versus placebo of CHI-902 in adults with SAD. * Explore the effects of CHI-902 versus placebo on different biomarkers in subjects with SAD.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	CHI-902	A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.
DRUG	Placebo	Placebo is a vehicle oil that will match CHI-902.

Timeline

• Start date: 2020-01-24
• Primary completion: 2021-01-26
• Completion: 2021-01-26
• First posted: 2019-09-11
• Last updated: 2020-06-04

Locations

2 sites across 1 country: Canada