Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

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.

Conditions

• Generalized Anxiety Disorder (GAD)
• Anxiety Disorders

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Wayne State University

  lead OTHER

Principal Investigators

• Hilary Marusak, PhD · Wayne State University

• Christine Rabinak, PhD, MBA · Wayne State Universty

• Leslie Lundahl, PhD · Wayne State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-03

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Drug

Yes

Countries

• United States

Study Locations