Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

• ClinicalTrials.gov Identifier: NCT05600114
• Recruitment Status: Active, not recruiting
• First Posted: October 31, 2022
• Last Update Posted: September 21, 2023
• Sponsor: EmpowerPharm Inc.
• Information provided by (Responsible Party): EmpowerPharm Inc.

Tracking Information

• First Submitted Date: October 26, 2022
• First Posted Date: October 31, 2022
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: October 27, 2022
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 26, 2022): Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 10 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Social Anxiety Disorder

Intervention

• Drug: Cannabidiol oral solution
  CBD 150 mg BID
• Drug: Cannabidiol oral solution
  CBD 300 mg BID
• Drug: Placebo
  Placebo BID

Study Arms

• Experimental: Cannabidiol (CBD) Oral Solution 300 mg/day
  Intervention: Drug: Cannabidiol oral solution
• Experimental: Cannabidiol (CBD) Oral Solution 600 mg/day
  Intervention: Drug: Cannabidiol oral solution
• Placebo Comparator: Placebo Oral Solution
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 26, 2022): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05600114
• Other Study ID Numbers: EPI-CBD-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: EmpowerPharm Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: EmpowerPharm Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: EmpowerPharm Inc.
• Verification Date: September 2023