Clinical trial NCT05600114: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Anxiety Disorder
Lead sponsor: EmpowerPharm Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: EPI-CBD-001 Site
state: California
city: Lemon Grove
country: United States
facility: EPI-CBD-001 Site
state: California
city: Los Alamitos
country: United States
facility: EPI-CBD-001 Site
state: California
city: Oceanside
country: United States
facility: EPI-CBD-001-Site
state: California
city: San Jose
country: United States
facility: EPI-CBD-001 site
state: California
city: Jacksonville
country: United States
facility: EPI-CBD-001 Site
state: Florida
city: Lauderhill
country: United States
facility: EPI-CBD-001 Site
state: Florida
city: Maitland
country: United States
facility: EPI-CBD-001 Site
state: Florida
city: Orlando
country: United States
facility: EPI-CBD-001 Site
state: Florida
city: Chicago
country: United States
facility: EPI-CBD-001 Site
state: Illinois
city: Cedarhurst
country: United States
facility: EPI-CBD-001 Site
state: New York
city: New York
country: United States
facility: EPI-CBD-001-Site
state: New York
city: Rochester
country: United States
facility: EPI-CBD-001-Site
state: New York
city: Oklahoma City
country: United States
facility: EPI-CBD-001 Site
state: Oklahoma
city: Portland
country: United States
facility: EPI-CBD-001 Site
state: Oregon
city: Wichita Falls
country: United States
facility: EPI-CBD-001 site
state: Texas
city: Bellevue
country: United States
facility: EPI-CBD-001 Site
state: Washington
Study officials:
References: