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RECRUITING
NCT07123467
PHASE3

Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

Sponsor: Wayne State University

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.

Official title: Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-11-03

Completion Date

2027-08-31

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Low-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.

DRUG

Placebo 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.

DRUG

Moderate-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.

DRUG

Placebo 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