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Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05600114
Recruitment Status : Active, not recruiting
First Posted : October 31, 2022
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
EmpowerPharm Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Cannabidiol oral solution Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol (CBD) Oral Solution 300 mg/day Drug: Cannabidiol oral solution
CBD 150 mg BID
Experimental: Cannabidiol (CBD) Oral Solution 600 mg/day Drug: Cannabidiol oral solution
CBD 300 mg BID
Placebo Comparator: Placebo Oral Solution Drug: Placebo
Placebo BID


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 10 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05600114


Locations
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United States, California
EPI-CBD-001 Site
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
United States, Florida
EPI-CBD-001 Site
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
United States, Illinois
EPI-CBD-001 Site
Chicago, Illinois, United States, 60640
United States, New York
EPI-CBD-001 Site
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
United States, Oklahoma
EPI-CBD-001 Site
Oklahoma City, Oklahoma, United States, 73106
United States, Oregon
EPI-CBD-001 Site
Portland, Oregon, United States, 97210
United States, Texas
EPI-CBD-001 site
Wichita Falls, Texas, United States, 76309
United States, Washington
EPI-CBD-001 Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
EmpowerPharm Inc.
More Information
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Responsible Party: EmpowerPharm Inc.
ClinicalTrials.gov Identifier: NCT05600114    
Other Study ID Numbers: EPI-CBD-001
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
 Cannabidiol
Pharmaceutical Solutions
Anticonvulsants