CBD for Social Anxiety Disorder

Overseen By David Tolin, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Hartford Hospital

Disqualifiers: Substance use, Mania, Schizophrenia, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Single session (2.5 hours)

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will randomly assign participants with social anxiety disorder to receive oral cannabidiol (CBD) or placebo. Participants will undergo a fear conditioning and extinction trial, and the investigators will examine whether CBD increases the degree of fear reduction during extinction.

Research Team

David Tolin, Ph.D.

Principal Investigator

Hartford Hospital

Eligibility Criteria

This trial is for adults over 18 with social anxiety disorder (SAD) of at least moderate severity. Participants must be able to understand English as the study materials are only in English. They should not be on medications that interact with cannabidiol (CBD).

Inclusion Criteria

I have been diagnosed with Social Anxiety Disorder.

My social anxiety is rated moderate or worse.

Able/willing to consent to participate in study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fear Conditioning

Participants undergo a fear conditioning paradigm with electrical stimulation paired with pictures of angry faces

Single session (2.5 hours)

Treatment

Participants receive orally administered CBD or placebo

Single session (2.5 hours)

Fear Extinction

Participants undergo a fear extinction phase where conditioned angry faces are shown repeatedly without electrical stimulus

Single session (2.5 hours)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Cannabidiol

Trial Overview The study tests if oral CBD can help reduce fear more effectively than a placebo during a process called fear extinction, which is part of therapy for SAD.

Participant Groups

Group I: Cannabidiol Experimental Treatment 2 Interventions

600 mg oral cannabidiol

Group II: Placebo Placebo Group 2 Interventions

Placebo capsules

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+