← Back to Search

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)
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control 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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,507 Total Patients Enrolled
Ananda ScientificUNKNOWN
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,393 Total Patients Enrolled

Media Library

Social Anxiety Disorder Research Study Groups: Cannabidiol 800mg, Placebo, Cannabidiol 400mg

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities to join this ongoing clinical trial?

"According to clinicaltrials.gov, this particular trail has been inactive since its last update on October 5th 2022 and is no longer in search of participants. Although the trial itself may not be recruiting, 414 other medical trials are currently enrolling patients."

Answered by AI

What qualifications must a person possess to participate in this clinical research?

"This medical trial is accepting applications from males and females aged 18-45 that suffer from Social anxiety Disorder (SAD) as confirmed by a certified clinical evaluator. The participant's overall social anxiety severity must be at least 60 when measured using the Liebowitz Social Anxiety Scale (LSAS). Furthermore, participants will have to commit to complying with study requirements such as abstaining from cannabis or tobacco use during the duration of the investigation."

Answered by AI

What would be the desired end results of this investigation?

"This clinical trial, observed over the period of one day and three weeks, seeks to quantify Change in TSST-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS). Secondary objectives include tracking a change in Clinical Global Impression of Severity (CGI-S) Score with an increase indicating more serious illness; Perceived Stress Scale (PSS-10) Score with higher numbers representing heightened stress levels; and Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) Score that uses raw scores from 8 - 40 translated into T-"

Answered by AI

What is the current status of Cannabidiol 400mg in terms of FDA approval?

"Based off of available evidence, our team at Power believes that Cannabidiol 400mg is moderately safe and assigned a score of 2. This reflects the fact that while some safety data exists for this product, no efficacy trials have been conducted yet."

Answered by AI

Does this medical research accept individuals older than forty?

"As delineated in the trial's entry requirements, only individuals between 18 and 45 years old can participate."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
NYU Langone Health
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Need a new option. I am interested in seeing where this treatment can possibly mean for me and my social anxiety.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is the total screening and the trial process?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
2023. "Cannabidiol as a Treatment for Social Anxiety Disorder (R61)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571592.
All > Anxiety Disorder > Social Anxiety
~10 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top