Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder
NCT ID: NCT05600114
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2022-10-27
2023-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cannabidiol (CBD) Oral Solution 300 mg/day
Cannabidiol oral solution
CBD 150 mg BID
Cannabidiol (CBD) Oral Solution 600 mg/day
Cannabidiol oral solution
CBD 300 mg BID
Placebo Oral Solution
Placebo
Placebo BID
Interventions
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Cannabidiol oral solution
CBD 150 mg BID
Cannabidiol oral solution
CBD 300 mg BID
Placebo
Placebo BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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EmpowerPharm Inc.
INDUSTRY
Responsible Party
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Locations
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EPI-CBD-001 Site
Encino, California, United States
EPI-CBD-001 Site
Lemon Grove, California, United States
EPI-CBD-001 Site
Los Alamitos, California, United States
EPI-CBD-001-Site
Oceanside, California, United States
EPI-CBD-001 site
San Jose, California, United States
EPI-CBD-001 Site
Jacksonville, Florida, United States
EPI-CBD-001 Site
Lauderhill, Florida, United States
EPI-CBD-001 Site
Maitland, Florida, United States
EPI-CBD-001 Site
Orlando, Florida, United States
EPI-CBD-001 Site
Chicago, Illinois, United States
EPI-CBD-001 Site
Cedarhurst, New York, United States
EPI-CBD-001-Site
New York, New York, United States
EPI-CBD-001-Site
Rochester, New York, United States
EPI-CBD-001 Site
Oklahoma City, Oklahoma, United States
EPI-CBD-001 Site
Portland, Oregon, United States
EPI-CBD-001 site
Wichita Falls, Texas, United States
EPI-CBD-001 Site
Bellevue, Washington, United States
Countries
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Other Identifiers
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EPI-CBD-001
Identifier Type: -
Identifier Source: org_study_id
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