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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cannabidiol (CBD) can reduce fear in people with social anxiety disorder (SAD). Participants will receive either CBD or a placebo to determine if CBD lessens anxiety during fear-related tasks. It is suitable for those diagnosed with SAD who experience moderate anxiety and can communicate in English. As an Early Phase 1 trial, this research focuses on understanding how CBD works in people, offering participants the opportunity to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications as long as they don't have a significant risk of interacting with CBD. It's best to discuss your specific medications with the study team to ensure they are safe to continue.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cannabidiol (CBD) might help reduce anxiety with few side effects. One study found that CBD lowered anxiety and stress hormone levels in patients. Another study demonstrated that CBD could reduce anxiety with minimal negative effects compared to a placebo. Although some results vary, these studies suggest that CBD is generally safe for humans.

This trial is in an early phase, meaning researchers are just beginning to test the treatment in people to assess its safety. Early-phase trials often have limited safety information. However, CBD is already approved for some medical uses, which provides some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for social anxiety disorder?

Unlike the standard medications for social anxiety disorder, which often include SSRIs like sertraline or SNRIs like venlafaxine, Cannabidiol (CBD) stands out because it's a natural compound derived from the cannabis plant. Researchers are excited about CBD because it targets the endocannabinoid system, a different pathway than traditional treatments, potentially offering relief with fewer side effects. There's also growing interest in CBD due to its non-psychoactive nature, meaning it doesn't produce a "high," which makes it a promising option for those looking for an alternative to typical anxiety medications.

What evidence suggests that this treatment might be an effective treatment for social anxiety disorder?

Research shows that cannabidiol (CBD), which participants in this trial may receive, can help reduce symptoms of social anxiety. Studies have found that regular use of CBD lowers social anxiety levels. In one study, teenagers with social anxiety disorder (SAD) felt less anxious after taking CBD for four weeks. The data also suggests that CBD reduces anxiety with fewer side effects than a placebo. These findings support the potential of CBD to help manage social anxiety symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

David Tolin, Ph.D.

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9983614/

Systematic literature review of human studies assessing ... These results suggest that repeated administration of CBD is effective in decreasing social anxiety symptoms, consistent with prior studies ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124003342

Therapeutic potential of cannabidiol (CBD) in anxiety ... Our findings suggest that CBD has promising efficacy in treating specific anxiety symptoms (including GAD, SAD, OCD, and PTSD) in addition to standard ...

3. nature.com nature.com/articles/s43856-022-00202-8

open-label data from a two-stage, phase 2 clinical trial To date, only one double-blind clinical trial has examined CBD for anxiety; teenagers with SAD exhibited reduced anxiety following 4 weeks of ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05823753

NCT05823753 | Cannabidiol to Reduce Anxiety Reactivity Higher scores reflect greater levels of anxiety. A standardized mean difference (SMD) decrease of 0.3 or greater in favor of CBD (either 300 mg/d or 900 mg/d) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11595441/

The Impact of Cannabidiol Treatment on Anxiety Disorders Despite these conflicting outcomes, the data suggest that CBD may reduce anxiety with minimal adverse effects when compared to a placebo.

6. reporter.nih.gov reporter.nih.gov/search/Sz95MmEj-Uu3HV2keOw4Nw/project-details/10706609

Project Details - NIH RePORTER Our overarching hypothesis is that CBD will improve well-established abnormalities present in fear neurocircuitry and performance stress responding in adults ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04086342

CHI-902 for Treatment of Social Anxiety Disorder This study will evaluate efficacy, therapeutic effects, tolerability and safety of CBD oil in adults with SAD through a randomized placebo-controlled study ...