Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EmpowerPharm Inc.
• Treatments: Cannabidiol; Pharmaceutical Solutions

Criteria

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