Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

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).

Inclusion Criteria:Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SADLSAS score of 70 or higherFemales 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 disorderPrevious 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 MDDUse of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeksElectroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 monthsClinically significant abnormality or clinically significant unstable medical conditionImpaired liver functionSignificant risk of suicide or homicidePregnancy/lactationSensitivity to CBD or excipientsCurrent cannabis use; past frequent cannabis useIllegal drug use