Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Cannabidiol oral solution; Drug: Cannabidiol oral solution

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anat Fields, Ph.D.; Phone Number: (289) 505-2677; Email: anat.fields@empowerpharm.ca

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • EPI-CBD-001 Site
    • Lemon Grove, California, United States, 91945
      • EPI-CBD-001 Site
    • Los Alamitos, California, United States, 90720
      • EPI-CBD-001 Site
    • Oceanside, California, United States, 92056
      • EPI-CBD-001-Site
    • San Jose, California, United States, 95124
      • EPI-CBD-001 Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • EPI-CBD-001 Site
    • Lauderhill, Florida, United States, 33319
      • EPI-CBD-001 Site
    • Maitland, Florida, United States, 32751
      • EPI-CBD-001 Site
    • Orlando, Florida, United States, 32801
      • EPI-CBD-001 Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • EPI-CBD-001 Site
  • New York
    • Cedarhurst, New York, United States, 11516
      • EPI-CBD-001 Site
    • New York, New York, United States, 10036
      • EPI-CBD-001-Site
    • Rochester, New York, United States, 10036
      • EPI-CBD-001-Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • EPI-CBD-001 Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • EPI-CBD-001 Site
  • Texas
    • Wichita Falls, Texas, United States, 76309
      • EPI-CBD-001 Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • EPI-CBD-001 Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cannabidiol (CBD) Oral Solution 300 mg/day	Drug: Cannabidiol oral solution; CBD 150 mg BID; Drug: Cannabidiol oral solution; CBD 300 mg BID
Experimental: Cannabidiol (CBD) Oral Solution 600 mg/day	Drug: Cannabidiol oral solution; CBD 150 mg BID; Drug: Cannabidiol oral solution; CBD 300 mg BID
Placebo Comparator: Placebo Oral Solution	Drug: Placebo; Placebo BID

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EmpowerPharm Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Anticonvulsants; Pharmaceutical Solutions; Cannabidiol
• Other Study ID Numbers: EPI-CBD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No