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Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Study acronym: CALM
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 1
    • Start date changed from estimate of Oct 1, 2025 to Nov 3, 2025
    v3
  2. Start date: Sep 1, 2025 to Oct 1, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Wayne State University
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Anxiety
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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.
Trial Details
NCT Number NCT07123467
Lead Sponsor Wayne State University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Generalized Anxiety Disorder (GAD), Anxiety Disorders
Related terms Anxiety Disorders, Generalized Anxiety Disorder
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov