Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Social Anxiety Disorder

In brief

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).

Key facts

Study ID

NCT05600114

Run by

EmpowerPharm Inc.

People needed

239

Starts

2022-10-27

Expected to finish

2023-12-13

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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