Clinical Trial

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Study acronym: CALM
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-13; most recent amendment 2026-03-06.
Status change: Not Yet Recruiting → Recruiting 2026-03-06
Trial Details
NCT Number NCT07123467
Lead Sponsor Wayne State University
Collaborators: National Institute of Mental Health (NIMH)
Conditions Generalized Anxiety Disorder (GAD), Anxiety Disorders
Enrollment 90 participants
Start Date 2025-11-03
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09