Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Cannabidiol oral solution
* Drug: Cannabidiol oral solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol (CBD) Oral Solution 300 mg/day<br> | Drug: Cannabidiol oral solution<br>* CBD 150 mg BID<br>|
| Experimental: Cannabidiol (CBD) Oral Solution 600 mg/day<br> | Drug: Cannabidiol oral solution<br>* CBD 300 mg BID<br>|
| Placebo Comparator: Placebo Oral Solution<br> | Drug: Placebo<br>* Placebo BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) |  | 10 weeks |