What side effects are associated with this type of intervention?

Common treatments for Social Anxiety Disorder (SAD) include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), benzodiazepines, and cognitive-behavioral therapy (CBT). SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety initially. Benzodiazepines may lead to drowsiness, dizziness, and dependency with long-term use. CBD, which is being studied for its potential to reduce stress and anxiety, has been associated with side effects like somnolence, dizziness, and gastrointestinal issues. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has not approved CBD or other cannabinoid-based treatments specifically for Social Anxiety Disorder. Current treatments for SAD typically include selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, and cognitive-behavioral therapy (CBT). While cannabinoids like CBD are being studied for their potential to reduce stress and anxiety by interacting with the endocannabinoid system, they have not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives to CBD for Social Anxiety Disorder patients include: 1) Selective Serotonin Reuptake Inhibitors (SSRIs) such as sertraline and paroxetine, which are well-established but continue to be refined and studied for their efficacy and side effect profiles. 2) Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) like venlafaxine, which are also established but have ongoing research for optimization. 3) Novel anxiolytics such as buspirone, which is being revisited for its potential benefits with fewer side effects. 4) Emerging therapies like psilocybin and MDMA-assisted psychotherapy, which are currently in clinical trials and showing promise for various anxiety disorders. 5) Digital therapeutics, including app-based cognitive behavioral therapy (CBT) programs, which are gaining traction as accessible and effective treatment options.

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Cannabinoid

CBD for Social Anxiety Disorder

Phase 2

Recruiting

Led By Naomi Simon, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately pre-dose, 60 minutes post-dose (up to week 3)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight. Since this is research on its effectiveness for anxiety treatment, monitoring will occur for any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately pre-dose, 60 minutes post-dose (up to week 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately pre-dose, 60 minutes post-dose (up to week 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately pre-dose, 60 minutes post-dose (up to week 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Change in Stress Task-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS)

Difference in Amygdala Beta-Weights in Activation in Response to Intensely Fearful Faces versus Neutral Faces as Measured by fMRI

Secondary study objectives

Change in Anxiety Sensitivity Index-3 (ASI-3) Score

Change in Clinical Global Impression of Improvement (CGI-I) Score

Change in Clinical Global Impression of Severity (CGI-S) Score

+10 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil Group

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cannabidiol 800mgExperimental Treatment1 Intervention

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

Group II: Cannabidiol 400mgExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Social Anxiety Disorder (SAD) include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and benzodiazepines. SSRIs and SNRIs work by increasing the levels of serotonin and norepinephrine in the brain, which helps to improve mood and reduce anxiety. Benzodiazepines enhance the effect of the neurotransmitter GABA, leading to a calming effect. Cannabidiol (CBD), currently under study, is thought to interact with the endocannabinoid system, potentially reducing stress and anxiety by modulating neurotransmitter release and promoting a sense of calm. These mechanisms are crucial for SAD patients as they target the underlying neurochemical imbalances that contribute to anxiety, thereby improving their ability to engage in social situations and enhancing their overall quality of life.