Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

Status Recruiting

Clinical Trial Summary

The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks. Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.

Clinical Trial Description

In the R61 trial, two doses of a Phase 3 trial suitable hemp-derived (legal) oral CBD formulation with enhanced bioavailability will be compared against placebo (PBO) in a 3-week double-blind randomized controlled trial. Participants will undergo a standardized stress task at week 2, and a standardized 2-day fear learning and extinction protocol at week 3, with functional MRI (fMRI) brain activation accompanying fear extinction recall and fearful faces tasks on the second day. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05571592
Study type	Interventional
Source	NYU Langone Health
Contact	Liza Goodwin
Phone	646-754-4773
Email	Elizabeth.Goodwin@nyulangone.org
Status	Recruiting
Phase	Phase 2
Start date	January 26, 2023
Completion date	August 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06274112` - Using TMS to Understand Neural Processes of Social Motivation	N/A
Completed	`NCT02554929` - Treatment of Social Anxiety Disorder and Selective Mutism	N/A
Completed	`NCT00684541` - Interpretation Modification Program for Social Phobia	N/A
Completed	`NCT00684320` - Attention Disengagement Training for Social Phobia	N/A
Completed	`NCT03247075` - Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT	N/A
Completed	`NCT02811458` - Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders	N/A
Withdrawn	`NCT04622930` - Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD)	N/A
Active, not recruiting	`NCT05018312` - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety	N/A
Active, not recruiting	`NCT05124639` - Clinical Trial of a Group Self-management Support Program for Anxiety Disorders	N/A
Completed	`NCT05858294` - The Safety, Acceptability and Efficacy of Alena	N/A
Active, not recruiting	`NCT05600114` - Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder	Phase 2
Not yet recruiting	`NCT06081348` - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	Phase 2
Not yet recruiting	`NCT02924610` - Brief Intervention to Reduce Fear	Phase 4
Active, not recruiting	`NCT02592564` - Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder	N/A
Recruiting	`NCT02305537` - Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment	N/A
Terminated	`NCT03764644` - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders	N/A
Unknown status	`NCT01712321` - Study of Vilazodone to Treat Social Anxiety Disorder	N/A
Completed	`NCT01320800` - CBT for Social Anxiety Disorder Delivered by School Counselors	Phase 2
Completed	`NCT00485888` - Flushing in Social Anxiety Disorder on Cipralex	Phase 2
Completed	`NCT00773162` - Flushing in Social Anxiety Disorder on Seroquel	Phase 3