Study of Cannabidiol EPIDIOLEX4 Combined With Cognitive Behavioral Therapy to Treat Adults Aged 18-45 With Generalized Anxiety Disorder

What this Trial Is About

Researchers are evaluating the use of FDA-approved cannabidiol EPIDIOLEX4 combined with cognitive behavioral therapy CBT for treating adults aged 18 to 45 with generalized anxiety disorder GAD. This randomized, double-blind, placebo-controlled trial aims to see if adding cannabidiol to CBT improves emotion regulation by activating the dorsomedial prefrontal cortex dmPFC and reduces anxiety symptoms compared to CBT with a placebo. Participants are randomly assigned to one of four groups brief CBT with moderate-dose cannabidiol, brief CBT with low-dose cannabidiol, brief CBT with placebo matched to moderate-dose cannabidiol, or brief CBT with placebo matched to low-dose cannabidiol. The moderate-dose cannabidiol group starts at 5 mgkgday and increases to 10 mgkgday after 6 days, while the low-dose group stays at 5 mgkgday. All treatments last 5 weeks, and the placebo groups receive matching solutions resembling cannabidiol. During the study, participants undergo brain scans using functional MRI to measure dmPFC activation during emotion regulation tasks before and after treatment. Researchers also assess anxiety symptom severity, treatment tolerability, and plasma levels of cannabidiol and related biomarkers. The primary outcome is the change in dmPFC activation from baseline to post-treatment around week 5, with various secondary brain activation and symptom measures recorded during the same period.

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder