Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Phase 2

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Drug: Cannabidiol oral solution; Drug: Placebo

• Registration Number: NCT05600114
• Lead Sponsor: EmpowerPharm Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study Start: 2022-10-27
• Study First Posted: 2022-10-31
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13
• Disposition First Posted: 2024-08-27
• Status Verified: 2024-11
• Disposition First Submitted: 2024-11-15
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabidiol (CBD) Oral Solution 300 mg/day	Cannabidiol oral solution	-
Cannabidiol (CBD) Oral Solution 600 mg/day	Cannabidiol oral solution	-
Placebo Oral Solution	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)	10 weeks

Trial Locations

Locations (3)

EPI-CBD-001-Site; 🇺🇸 Rochester, New York, United States

EPI-CBD-001 Site; 🇺🇸 Bellevue, Washington, United States

EPI-CBD-001 site; 🇺🇸 Wichita Falls, Texas, United States