Actively Recruiting
Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
Led by Wayne State University · Updated on 2026-03-09
90
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
W
Wayne State University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Right-handed
- Age 18-45 years at enrollment
- Able to consent to the study
- Agree to adhere to lifestyle considerations throughout study duration
- Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment
- Have a current generalized anxiety disorder (GAD) diagnosis according to the DSM-5 criteria and/or total scores 2 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)
You will not qualify if you...
- Clinically significant medical or neurologic condition or neurocognitive dysfunction affecting function, task performance, or study protocol
- Current or recent (past 2 months) medical condition requiring medication interacting with cannabidiol or interfering with the study
- Risk of harm to self or others requiring immediate intervention
- Contraindications, allergy, or sensitivity to cannabinoid substances or EPIDIOLEX4 components
- Positive drug screen or alcohol breathalyzer
- Unwilling or unable to sign informed consent
- Currently pregnant, planning pregnancy, or lactating
- Under 18 or over 45 years old
- Traumatic brain injury as defined by specific clinical criteria
- Inability to tolerate small enclosed spaces (e.g., claustrophobia)
- Presence of ferrous-containing metals in the body
- Receiving or received psychotherapy within past year
- Current moderate or severe alcohol/drug use disorder or in past 8 weeks
- Current or past bipolar, schizophrenia spectrum, or other psychotic disorders
- GAD-7 score less than 8
- Use of medications with severe interactions with cannabidiol or strong CYP3A4/CYP2C19 inducers
- Visual impairment
- Abnormal baseline lab results three times outside normal range
- Use of as-needed anti-anxiety meds, unstable psychoactive drugs, or intention to start new treatments during trial
- Cannabis or THC/cannabidiol use in past month
- Recent COVID-19 diagnosis or febrile illness
- Treatment with other investigational drugs in past month
- Difficulty or inability to comply with the clinical trial protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wayne State University School of Medicine, Tolan Park Medical Building
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
H
Hilary Marusak, PhD
CONTACT
C
Christine Rabinak, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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