Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

NCT ID: NCT05600114

Last Updated: 2024-11-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2023-12-13

Brief Summary

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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).

Detailed Description

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Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cannabidiol (CBD) Oral Solution 300 mg/day

Group Type EXPERIMENTAL

Cannabidiol oral solution

Intervention Type DRUG

CBD 150 mg BID

Cannabidiol (CBD) Oral Solution 600 mg/day

Group Type EXPERIMENTAL

Cannabidiol oral solution

Intervention Type DRUG

CBD 300 mg BID

Placebo Oral Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID

Interventions

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Cannabidiol oral solution

CBD 150 mg BID

Intervention Type DRUG

Cannabidiol oral solution

CBD 300 mg BID

Intervention Type DRUG

Placebo

Placebo BID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EmpowerPharm Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EPI-CBD-001 Site

Encino, California, United States

Site Status

EPI-CBD-001 Site

Lemon Grove, California, United States

Site Status

EPI-CBD-001 Site

Los Alamitos, California, United States

Site Status

EPI-CBD-001-Site

Oceanside, California, United States

Site Status

EPI-CBD-001 site

San Jose, California, United States

Site Status

EPI-CBD-001 Site

Jacksonville, Florida, United States

Site Status

EPI-CBD-001 Site

Lauderhill, Florida, United States

Site Status

EPI-CBD-001 Site

Maitland, Florida, United States

Site Status

EPI-CBD-001 Site

Orlando, Florida, United States

Site Status

EPI-CBD-001 Site

Chicago, Illinois, United States

Site Status

EPI-CBD-001 Site

Cedarhurst, New York, United States

Site Status

EPI-CBD-001-Site

New York, New York, United States

Site Status

EPI-CBD-001-Site

Rochester, New York, United States

Site Status

EPI-CBD-001 Site

Oklahoma City, Oklahoma, United States

Site Status

EPI-CBD-001 Site

Portland, Oregon, United States

Site Status

EPI-CBD-001 site

Wichita Falls, Texas, United States

Site Status

EPI-CBD-001 Site

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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EPI-CBD-001

Identifier Type: -

Identifier Source: org_study_id

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