CBD for Social Anxiety Disorder

Overseen by Esther Blessing, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: NYU Langone Health

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

Disqualifiers: Bipolar, Schizophrenia, Psychosis, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests two doses of CBD in willing participants to see if it helps reduce stress and fear by interacting with the body's natural systems. Oral administration of cannabidiol (CBD) has shown to yield a variety of therapeutic benefits among humans, particularly regarding symptoms of anxiety.

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.

What evidence supports the effectiveness of the drug CBD for treating social anxiety disorder?

Research shows that CBD can significantly reduce anxiety symptoms in people with social anxiety disorder. Studies found that both single and repeated doses of CBD decreased anxiety levels during social situations, suggesting it may be a promising treatment option. ^{1 2 3 4 5}

Is CBD safe for humans?

Research suggests that CBD is generally safe for humans, as it does not cause sedating side effects or addiction. However, more studies are needed to understand its long-term safety and effects. ^{2 5 6 7 8}

How does the drug CBD differ from other treatments for social anxiety disorder?

CBD is unique because it is a non-addictive component of the cannabis plant that reduces anxiety without causing sedation, unlike many traditional anxiety medications. It works quickly and has shown promise in reducing social anxiety symptoms in both single and repeated doses, making it a potentially effective alternative for those who do not respond well to existing treatments. ^{1 2 3 4 5}

Research Team

Naomi Simon, MD

Principal Investigator

NYU Langone Health

Esther Blessing, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Cannabidiol (Cannabinoid)
• Placebo (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Ananda Scientific

Collaborator

Trials

1

Recruited

60+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic literature review of human studies assessing the efficacy of cannabidiol for social anxiety. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naïve social phobia patients. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Subjective, behavioral and neurobiological effects of cannabis and cannabinoids in social anxiety. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. [2023]

7. Germany 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. [2022]