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NCT05600114 Clinical Trial

Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05600114
Other study ID # EPI-CBD-001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 27, 2022
Est. completion date December 2023

Study information
Verified date September 2023
Source EmpowerPharm Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 225
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD - LSAS score of 70 or higher - Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception. - Read, understand, and sign the informed consent form. - No significant physical health abnormalities based on physical exam, ECG and laboratory tests. Exclusion Criteria: - Other current psychiatric disorder as the clinically predominant diagnosis. - Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder - Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder) - Severe MDD - Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks - Electroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 months - Clinically significant abnormality or clinically significant unstable medical condition - Impaired liver function - Significant risk of suicide or homicide - Pregnancy/lactation - Sensitivity to CBD or excipients - Current cannabis use; past frequent cannabis use - Illegal drug use

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabidiol oral solution
CBD 150 mg BID
• Cannabidiol oral solution
CBD 300 mg BID
• Placebo
Placebo BID

Locations
Country Name City State
United States EPI-CBD-001 Site Bellevue Washington
United States EPI-CBD-001 Site Cedarhurst New York
United States EPI-CBD-001 Site Chicago Illinois
United States EPI-CBD-001 Site Encino California
United States EPI-CBD-001 Site Jacksonville Florida
United States EPI-CBD-001 Site Lauderhill Florida
United States EPI-CBD-001 Site Lemon Grove California
United States EPI-CBD-001 Site Los Alamitos California
United States EPI-CBD-001 Site Maitland Florida
United States EPI-CBD-001-Site New York New York
United States EPI-CBD-001-Site Oceanside California
United States EPI-CBD-001 Site Oklahoma City Oklahoma
United States EPI-CBD-001 Site Orlando Florida
United States EPI-CBD-001 Site Portland Oregon
United States EPI-CBD-001-Site Rochester New York
United States EPI-CBD-001 site San Jose California
United States EPI-CBD-001 site Wichita Falls Texas

Sponsors (1)
Lead Sponsor Collaborator
EmpowerPharm Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) 10 weeks
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