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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)
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 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
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
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,022 Total Patients Enrolled
Ananda ScientificUNKNOWN
National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,776 Total Patients Enrolled
Naomi Simon, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
213 Total Patients Enrolled
Esther Blessing, MDPrincipal InvestigatorNYU Langone Health
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol 800mg
- Group 2: Placebo
- Group 3: Cannabidiol 400mg