CBD for Social Anxiety Disorder

Overseen By Noah Wilson

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Antipsychotics, Anticonvulsants, Benzodiazepines, Opioids

Disqualifiers: Bipolar, Schizophrenia, Psychosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if CBD, a compound found in cannabis, can reduce social anxiety. Researchers will compare two doses of CBD with a placebo, a harmless pill with no active drug, to assess its effectiveness. Participants will take either 800 mg, 400 mg, or a placebo twice daily for three weeks. Suitable candidates have social anxiety as their primary mental health issue and can commit to avoiding cannabis products during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

Yes, you must stop taking certain medications, especially psychotropic drugs like antipsychotics, anticonvulsants, benzodiazepines, and opioids, as well as medications that affect specific liver enzymes, at least 4 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cannabidiol (CBD) is generally safe for treating social anxiety disorder (SAD). Reviews of several studies indicate that most people tolerate CBD well. Common side effects are usually mild and may include fatigue or changes in appetite.

In some studies, participants used CBD for several weeks without serious issues. One study found that CBD did not cause significant unwanted effects when used in appropriate amounts. Overall, this evidence suggests that CBD is a safe option for those considering it for anxiety-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabidiol (CBD) for treating Social Anxiety Disorder because it's a natural compound derived from cannabis plants, offering a potentially new mechanism of action compared to the standard treatments like SSRIs and benzodiazepines. Unlike traditional medications that primarily alter serotonin levels, CBD interacts with the endocannabinoid system, which may help regulate mood and anxiety. This could mean fewer side effects and a different approach to managing anxiety symptoms, which is why there's a lot of interest in seeing how effective CBD could be for those who haven't found relief with existing treatments.

What evidence suggests that this trial's treatments could be effective for social anxiety disorder?

Research has shown that cannabidiol (CBD) may help reduce symptoms of social anxiety. Studies have found that regular CBD intake can lower anxiety, particularly in individuals with social anxiety disorder (SAD). In this trial, participants will receive either a 400mg or 800mg daily dose of CBD, or a placebo, for three weeks. One previous trial found that teenagers with SAD felt less anxious after four weeks of CBD treatment. Additionally, CBD tends to manage anxiety with fewer side effects than a placebo. Overall, these findings suggest that CBD could be a helpful treatment for social anxiety. ^{1 2 6 7 8}

Who Is on the Research Team?

Naomi Simon, MD

Principal Investigator

NYU Langone Health

Esther Blessing, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults aged 18-45 with Social Anxiety Disorder, confirmed by a clinical interview and an LSAS score of at least 60. Participants must not use marijuana or related products during the study and should be free from certain medications for 4 weeks prior. Pregnant women, those with severe medical conditions, metal implants incompatible with MRI, or recent psychotherapy for SAD are excluded.

Inclusion Criteria

Willingness and ability to participate in the informed consent process and comply with the study protocol, including restrictions on marijuana, cannabis-related products, and tobacco use

Overall social anxiety severity defined by a Liebowitz Social Anxiety Scale (LSAS) score of at least 60

My primary mental health issue is Social Anxiety Disorder.

Exclusion Criteria

I am not taking any psychotropic medications or other drugs that are not allowed.

Contraindications for MRI

Pregnancy or lack of medically accepted contraception for women of childbearing potential

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Initial assessments and baseline measurements are conducted

1 week

Treatment

Participants receive either CBD 800 mg, CBD 400 mg, or placebo twice daily for three weeks

3 weeks

Weekly in-person visits for clinical safety assessments

Week 2 Stress Task

Participants undergo a standardized stress task

1 day

Week 3 Imaging Paradigm

Participants undergo a 2-day fear learning and extinction protocol with fMRI

2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

Trial Overview The trial is testing two different doses of Cannabidiol (CBD) against a placebo to see if it helps with social anxiety. Participants will randomly receive either CBD (800 mg or 400 mg daily) or a placebo over three weeks, including stress tasks and imaging studies to measure effects.

How Is the Trial Designed?

Group I: Cannabidiol 800mg Experimental Treatment 1 Intervention

Participants assigned to 400mg twice-daily (800mg/day) dose for 3 weeks.

Group II: Cannabidiol 400mg Experimental Treatment 1 Intervention

Participants assigned to 200mg twice-daily (400mg/day) dose for 3 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants assigned to twice-daily placebo dose for 3 weeks.

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?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Ananda Scientific

Collaborator

Trials

1

Recruited

60+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a study involving 24 treatment-naïve patients with Generalized Social Anxiety Disorder (SAD), a single dose of 600 mg of CBD significantly reduced anxiety and cognitive impairment during a public speaking test compared to a placebo group.

The effects of CBD allowed SAD patients to perform similarly to healthy controls in terms of anxiety levels and discomfort, suggesting that CBD may be an effective treatment option for managing symptoms of social anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naïve social phobia patients. Bergamaschi, MM., Queiroz, RH., Chagas, MH., et al.[2022]

In a study comparing the effects of cannabidiol (CBD) on anxiety in male and female rats, it was found that female rats showed a significant response to CBD only during the late diestrus phase of their estrous cycle, requiring a much lower dose than males.

Both sexes exhibited anxiolytic-like effects from CBD, but the differences in responsiveness suggest that hormonal fluctuations in females may influence the drug's effectiveness, highlighting the need for sex-specific considerations in CBD treatment for anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. Fabris, D., Carvalho, MC., Brandão, ML., et al.[2023]

A study involving 61 healthy young adults found that a single oral dose of cannabidiol (CBD) did not reduce fear reactivity during a carbon dioxide challenge, indicating that CBD may not be effective for this purpose.

Despite previous evidence suggesting CBD can reduce anxiety, this research highlights that it does not impact self-reported fear or physiological responses, marking a significant finding in the understanding of CBD's effects on fear in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled test of the effects of cannabidiol on fear elicited by a 10% carbon dioxide-enriched air breathing challenge. Leen-Feldner, EW., Bynion, TM., Eglit, GML., et al.[2022]

In a 12-week open-label trial involving 31 young people aged 12-25 with treatment-resistant anxiety disorders, cannabidiol (CBD) significantly reduced anxiety severity by 42.6%, as measured by the Overall Anxiety Severity and Impairment Scale (OASIS).

CBD was found to have an adequate safety profile, with 80.6% of participants reporting mild adverse events like fatigue and low mood, but no serious or unexpected adverse events were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. Berger, M., Li, E., Rice, S., et al.[2022]

Cannabidiol (CBD) has been found to effectively reduce social anxiety at intermediate doses (300-600 mg), while lower or higher doses do not have the same effect, indicating a dose-dependent response.

Delta-9-tetrahydrocannabinol (THC) can either reduce or increase social anxiety depending on the dose, with lower doses showing a reduction and higher doses leading to an increase, suggesting that CBD may help mitigate the anxiety-inducing effects of THC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective, behavioral and neurobiological effects of cannabis and cannabinoids in social anxiety. Rosário, BDA., Lemes, JA., de Lima, MP., et al.[2023]

In a study involving 10 treatment-naïve patients with generalized social anxiety disorder, a single oral dose of 400 mg of cannabidiol (CBD) significantly reduced subjective anxiety compared to a placebo.

The anxiolytic effects of CBD were linked to changes in brain activity, specifically decreased blood flow in areas like the left parahippocampal gyrus and increased activity in the right posterior cingulate gyrus, suggesting a mechanism involving limbic and paralimbic brain regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. Crippa, JA., Derenusson, GN., Ferrari, TB., et al.[2022]

In a double-blind study involving 37 Japanese teenagers with social anxiety disorder, daily treatment with 300 mg of cannabidiol (CBD) for 4 weeks significantly reduced anxiety symptoms.

The effectiveness of CBD was measured using established scales, showing promise as a non-addictive treatment option for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiolytic Effects of Repeated Cannabidiol Treatment in Teenagers With Social Anxiety Disorders. Masataka, N.[2020]

Cannabidiol (CBD) shows promise as a treatment for social anxiety disorder (SAD), significantly reducing anxiety in both healthy volunteers and individuals with SAD without causing sedation, based on a systematic review of existing literature.

Chronic administration of CBD has been shown to decrease social anxiety symptoms in individuals with SAD, indicating its potential as a viable alternative to current treatments, though further research is needed to determine optimal dosing and long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic literature review of human studies assessing the efficacy of cannabidiol for social anxiety. Fliegel, DK., Lichenstein, SD.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol Some studies indicate that under certain circumstances, CBD acute anxiolytic effects in rats were reversed after repeated 14-day administration of CBD. However, ...

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

CHI-902 for Treatment of Social Anxiety Disorder This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD.

8. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2055/randomized-placebo-controlled-trial/

Randomized placebo controlled trial to determine the ... Randomized placebo controlled trial to determine the biological signature of cannabidiol as a treatment for social anxiety disorder · Brief description of study.