Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

EmpowerPharm

Status and phase: Completed; Phase 2

Conditions: Social Anxiety Disorder

Treatments: Drug: Cannabidiol oral solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05600114

EPI-CBD-001

Details and patient eligibility

About

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).

Enrollment: 239 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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239 participants in 3 patient groups, including a placebo group

Cannabidiol (CBD) Oral Solution 300 mg/day

Experimental group

Treatment:

Drug: Cannabidiol oral solution

Drug: Cannabidiol oral solution

Cannabidiol (CBD) Oral Solution 600 mg/day

Experimental group

Treatment:

Drug: Cannabidiol oral solution

Drug: Cannabidiol oral solution

Placebo Oral Solution

Placebo Comparator group

Treatment:

Drug: Placebo