Study Summary
This trial will study whether CBD can help reduce stress and improve brain function. It will last for 3 weeks and will compare CBD at two different doses to a placebo.
Eligible Conditions
- Social Anxiety Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 13 Secondary · Reporting Duration: Immediately Pre-Dose, 60 Minutes Post-Dose (Up to Week 3)
Week 2
Change in Stress Task-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS)
Anxiety
Day 1, Week 3
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
Anxiety
Change in Insomnia Severity Index (ISI) Score
Anxiety
Change in Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) Score
Change in Patient-Reported Outcomes Measurement Information System Satisfaction with Participation in Social Roles (PROMIS-SPS) Score
Change in Perceived Stress Scale (PSS-10) Score
Mental Depression
Change in Self-Statements during Public Speaking Scale: Negative Thoughts (SSPS-N) Score
Week 3
Plasma Exchange
Up to Week 3
Number of Participants who Adhere to Treatment
Week 3
Difference in Amygdala Beta-Weights in Activation in Response to Intensely Fearful Faces versus Neutral Faces as Measured by fMRI
Prefrontal Cortex
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Control Group
29%Tiredness
20%Constipation
18%Drowsiness
11%Dizziness
11%Poor sleep
9%Poor Appetite
9%Headache
4%Nausea
4%Itching
2%Diarrhea
Trial Design
3 Treatment Groups
Cannabidiol 400mg
1 of 3
Cannabidiol 800mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
60 Total Participants · 3 Treatment Groups
Primary Treatment: Cannabidiol 400mg · Has Placebo Group · Phase 2
Cannabidiol 400mg
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: DrugCannabidiol 800mg
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2018
Completed Phase 3
~980
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately pre-dose, 60 minutes post-dose (up to week 3)
Who is running the clinical trial?
Ananda ScientificUNKNOWN
National Center for Complementary and Integrative Health (NCCIH)NIH
780 Previous Clinical Trials
643,973 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,263 Previous Clinical Trials
753,528 Total Patients Enrolled
Esther Blessing, MDPrincipal InvestigatorNYU Langone Health
Naomi Simon, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
221 Total Patients Enrolled
Eligibility Criteria
Age 18 - 45 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your primary mental health complaint is Social Anxiety Disorder, as defined by the DSM-5 criteria.
You have a minimum LSAS score of 60, indicating severe social anxiety.
You are between 18 and 45 years of age, inclusive, and not admitted to the hospital if you are male or female.
You are willing and able to abide by the protocols set forth in the Informed Consent Form (ICF) as well as abstain from using marijuana, cannabis-related products, or tobacco products during study participation.
Who else is applying?
What state do they live in?
| New York | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments