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Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol oral solution
Cannabidiol oral solution
Placebo
Sponsored by
EmpowerPharm Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001-Site
  • EPI-CBD-001 site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001-Site
  • EPI-CBD-001-Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 Site
  • EPI-CBD-001 site
  • EPI-CBD-001 Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cannabidiol (CBD) Oral Solution 300 mg/day

Cannabidiol (CBD) Oral Solution 600 mg/day

Placebo Oral Solution

Arm Description

Outcomes

Primary Outcome Measures

Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
September 18, 2023
Sponsor
EmpowerPharm Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05600114
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EmpowerPharm Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol (CBD) Oral Solution 300 mg/day
Arm Type
Experimental
Arm Title
Cannabidiol (CBD) Oral Solution 600 mg/day
Arm Type
Experimental
Arm Title
Placebo Oral Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cannabidiol oral solution
Intervention Description
CBD 150 mg BID
Intervention Type
Drug
Intervention Name(s)
Cannabidiol oral solution
Intervention Description
CBD 300 mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID
Primary Outcome Measure Information:
Title
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
EPI-CBD-001 Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
EPI-CBD-001 Site
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
EPI-CBD-001 Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
EPI-CBD-001-Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
EPI-CBD-001 site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
EPI-CBD-001 Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
EPI-CBD-001 Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
EPI-CBD-001 Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
EPI-CBD-001 Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
EPI-CBD-001 Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
EPI-CBD-001 Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
EPI-CBD-001-Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
EPI-CBD-001-Site
City
Rochester
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
EPI-CBD-001 Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
EPI-CBD-001 Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
EPI-CBD-001 site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
EPI-CBD-001 Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

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Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

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