Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05600114

Enrollment

239

Registered

2022-10-31

Start date

2022-10-27

Completion date

2023-12-13

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

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).

Interventions

DRUGCannabidiol oral solution

CBD 150 mg BID

DRUGPlacebo

Placebo BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)	10 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026