NCT05600114

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

October 26, 2022

Last Update Submit

November 19, 2024

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

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

    10 weeks

Study Arms (3)

Cannabidiol (CBD) Oral Solution 300 mg/day

EXPERIMENTAL
Drug: Cannabidiol oral solution

Cannabidiol (CBD) Oral Solution 600 mg/day

EXPERIMENTAL
Drug: Cannabidiol oral solution

Placebo Oral Solution

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Cannabidiol oral solutionDRUG

CBD 150 mg BID

Cannabidiol (CBD) Oral Solution 300 mg/day
PlaceboDRUG

Placebo BID

Placebo Oral Solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

EPI-CBD-001 Site

Encino, California, 91316, United States

Location

EPI-CBD-001 Site

Lemon Grove, California, 91945, United States

Location

EPI-CBD-001 Site

Los Alamitos, California, 90720, United States

Location

EPI-CBD-001-Site

Oceanside, California, 92056, United States

Location

EPI-CBD-001 site

San Jose, California, 95124, United States

Location

EPI-CBD-001 Site

Jacksonville, Florida, 32256, United States

Location

EPI-CBD-001 Site

Lauderhill, Florida, 33319, United States

Location

EPI-CBD-001 Site

Maitland, Florida, 32751, United States

Location

EPI-CBD-001 Site

Orlando, Florida, 32801, United States

Location

EPI-CBD-001 Site

Chicago, Illinois, 60640, United States

Location

EPI-CBD-001 Site

Cedarhurst, New York, 11516, United States

Location

EPI-CBD-001-Site

New York, New York, 10036, United States

Location

EPI-CBD-001-Site

Rochester, New York, 10036, United States

Location

EPI-CBD-001 Site

Oklahoma City, Oklahoma, 73106, United States

Location

EPI-CBD-001 Site

Portland, Oregon, 97210, United States

Location

EPI-CBD-001 site

Wichita Falls, Texas, 76309, United States

Location

EPI-CBD-001 Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

October 27, 2022

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

US(17)