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Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder
Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder
Who can join
Ages 18 to 45 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and/or total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7) Exclusion Criteria: * 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® * Positive drug screen or alcohol breathalyzer * Unwilling/unable to sign informed consent document * Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women), * Under 18 or over 45 years of age * Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement \[i.e., whiplash\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient) * Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner * Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles) * Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year * Current moderate or severe alcohol/drug use disorder or in the past 8 weeks * Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders; * GAD-7 score \< 8 * Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19) * Visual impairment * Baseline labs 3 times outside of normal range * Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \< 4 weeks), or intention to start new treatment during this trial * Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen) * Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness * Treatment with another investigational drug or intervention within the past month * Difficulty with or inability to comply with the complete clinical trial.
About the study
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.
What is being tested
- Low-Dose Cannabidiol (drug)
- Placebo Matched to Moderate-Dose Cannabidiol (drug)
- Moderate-Dose Cannabidiol (drug)
- Placebo Matched to Low-Dose Cannabidiol (drug)
Sponsor: Wayne State University · Participants: 90 · Started: Nov 3, 2025
Contact the study team
- Hilary Marusak, PhD · Phone: (313) 577-1278
- Christine Rabinak, PhD, MBA · Phone: (313) 577-9875
Official record on ClinicalTrials.gov — NCT07123467
Locations in the U.S.
| Michigan | Wayne State University School of Medicine, Tolan Park Medical Building, Detroit |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.