Cannabidiol for the Treatment of Acute Anticipatory Anxiety in Patients with Stage IV Breast Cancer

Inclusion Criteria

• Diagnosis of stage IV or metastatic breast cancer
• Age >= 18 years
• Karnofsky >= 60%
• Total bilirubin =< 2 times institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
• Baseline at least mild anxiety as measured by Generalized Anxiety Disorder (GAD)-7 >= 5
• Experience of at least mild anxiety typically tied to anticipation of oncologic scans (as measured by a prescreen survey item)
• Computed tomography or positron emission tomography (PET) to assess tumor burden scheduled for within 48 hours of study drug administration
• No cannabis, delta-9-tetrahydrocannabinol or cannabidiol use within 24-hours of study drug administration
• No benzodiazepine consumption within 8 hours of study drug administration (e.g., nighttime benzodiazepine use permissible)
• No driving for 12 hours following study drug administration
• English proficiency
• The effects of cannabidiol (Epidiolex) on the developing human fetus are unknown. For this reason and because cannabis is known to be teratogenic, women of child-bearing potential must not be pregnant when entering the study. The study team will encourage women of child-bearing age to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Women must agree to use adequate contraception prior to the study, for the duration of study participation, and for 1 week after cannabidiol (Epidiolex) consumption. Women either age >= 54 years or documented to be in menopause or status post hysterectomy will not be required to obtain beta human chorionic gonadotropin (bHCG).
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabidiol (Epidiolex) or placebo (which contains sesame, corn and gluten)
• Current clobazam or valproic acid use
• Current uncontrolled illness, for instance sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
• Current use of antiretroviral therapy
• Participants with psychiatric illness or social situations that would limit compliance with study requirements
• Current hepatocellular carcinoma or documented history of difficult to control diabetes
• Active participation in a clinical drug trial