RecruitingPhase 3NCT07123467

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder

Sponsor

Wayne State University

Enrollment

90 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Disorders Generalized Anxiety Disorder (GAD)

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cannabidiol (CBD) can help enhance a type of cognitive therapy called fear extinction learning, which is used to treat generalized anxiety disorder (GAD) — a condition where people experience chronic, hard-to-control worry. **You may be eligible if...** - You are 18–45 years old and right-handed - You have a diagnosis of generalized anxiety disorder - You are generally healthy with no major neurological or cognitive conditions - You are willing to follow lifestyle guidelines during the study **You may NOT be eligible if...** - You have a serious medical or psychiatric condition beyond anxiety - You are pregnant or planning to become pregnant - You currently use cannabis regularly - You have a history of substance use disorders - You have contraindications to CBD Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLow-Dose Cannabidiol

Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Low-dose participants receive 5 milligram/kilogram/day throughout. The intervention targets emotion regulation circuitry and symptom improvement.

DRUGPlacebo Matched to Moderate-Dose Cannabidiol

The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate-dose cannabidiol arm, dosing starts at 5 mg/kg/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days.

DRUGModerate-Dose Cannabidiol

Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Moderate-dose participants receive 5 milligram/kilogram/day for 6 days, then titrate to 10 milligram/kilogram/day. The intervention targets emotion regulation circuitry and symptom improvement.

DRUGPlacebo Matched to Low-Dose Cannabidiol

The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the low-dose cannabidiol arm, dosing is maintained at 5 milligram/kilogram/day (divided twice a day) throughout the treatment period. No titration is required.

Locations(1)

Wayne State University School of Medicine, Tolan Park Medical Building

Detroit, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07123467

Related Trials

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

NCT000180571 location

Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders

NCT003971111 location