Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder

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 ofintellectual disability or serious cognitive impairment

• Have a current generalized anxiety disorder (GAD) diagnosis according to the TheDiagnostic 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 dysfunctionthat would affect function and/or task performance and/or interfere with the studyprotocol

• Any current (or within past 2 months) medical condition requiring medication thatwould 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, orknown 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 aperson who has had a traumatically induced physiological disruption of brainfunction (i.e., the head being struck, the head striking an object, and/or the brainundergoing an acceleration/deceleration movement [i.e., whiplash] without directexternal trauma to the head), as manifested by at least one of the following: anyloss of consciousness; any loss of memory for events immediately before or after theinjury; any alteration in mental status at the time of the incident; or focalneurological 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 forresearch 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, schizophreniaspectrum, or other psychotic disorders;

• GAD-7 score < 8

• Use of medications known to have severe drug interactions with cannabidiol or thatare 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 ofother psychoactive drug (i.e., < 4 weeks), or intention to start new treatmentduring this trial

• Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) orcannabidiol-containing product (self-report and urine drug screen)

• Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrileillness

• Treatment with another investigational drug or intervention within the past month

• Difficulty with or inability to comply with the complete clinical trial.