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Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Sponsor
EmpowerPharm Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05600114
Collaborator
(none)
225
Enrollment
20
Locations
3
Arms
10.2
Anticipated Duration (Months)
11.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Cannabidiol oral solution
  • Drug: Cannabidiol oral solution
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 27, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 EPI-CBD-001 Site Encino California United States 91316
2 EPI-CBD-001 Site Garden Grove California United States 92845
3 EPI-CBD-001 Site Lemon Grove California United States 91945
4 EPI-CBD-001 Site Los Alamitos California United States 90720
5 EPI-CBD-001-Site Oceanside California United States 92056
6 EPI-CBD-001 site San Jose California United States 95124
7 EPI-CBD-001 Site Colorado Springs Colorado United States 80910
8 EPI-CBD-001 Site Jacksonville Florida United States 32256
9 EPI-CBD-001 Site Lauderhill Florida United States 33319
10 EPI-CBD-001 Site Maitland Florida United States 32751
11 EPI-CBD-001 Site Orlando Florida United States 32801
12 EPI-CBD-001 Site Chicago Illinois United States 60640
13 EPI-CBD-001 Site Cedarhurst New York United States 11516
14 EPI-CBD-001-Site New York New York United States 10036
15 EPI-CBD-001-Site Rochester New York United States 10036
16 EPI-CBD-001 Site Dayton Ohio United States 45417
17 EPI-CBD-001 Site Oklahoma City Oklahoma United States 73106
18 EPI-CBD-001 Site Portland Oregon United States 97210
19 EPI-CBD-001 site Memphis Tennessee United States 38119
20 EPI-CBD-001 site Wichita Falls Texas United States 76309

Sponsors and Collaborators

  • EmpowerPharm Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EmpowerPharm Inc.
ClinicalTrials.gov Identifier:
NCT05600114
Other Study ID Numbers:
  • EPI-CBD-001
First Posted:
Oct 31, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Cannabidiol
Pharmaceutical Solutions

Study Results

No Results Posted as of Nov 29, 2022