Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWayne State University
About this trial
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.
Eligibility criteria
Qualifiers
Right-handed
Age 18-45 years at enrollment
Able to consent to the study
Agree to adhere to lifestyle considerations throughout study duration
Disqualifiers
Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol
Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol
Risk of harm to self or others that requires immediate intervention
Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®
Trial design
Treatments tested in this trial
- Low-Dose Cannabidiol
- Placebo Matched to Moderate-Dose Cannabidiol
- Moderate-Dose Cannabidiol
- Placebo Matched to Low-Dose Cannabidiol
Treatment groups
90 Participants
are divided into 4 treatment groupsSponsors and collaborators
Wayne State University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov