A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients

Open to people ages 18 years and up

• Documentation of newly diagnosed glioblastoma, evidenced by neuropathology report and based on World Health Organization (WHO) 2021 classification, and who are to undergo SOC (~ 6 weeks of treatment) with radiation and temozolomide (patients using Optune may be included).
• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• Fluent in English.
• Endorses at least moderate levels of anxiety (on the BAI or OASIS) at the screening visit
• Stable medication/psychotherapy regimens for at least 1 month prior to starting the study (excluding new glioblastoma treatment-related medications or radiation).
• Karnofsky Performance Scale (KPS) of 60 or higher.

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Presence of a condition or abnormality that in the opinion of the Investigators would compromise the safety of the patient or the quality of the data.
• Current substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.
• Current use of recreational cannabis, medical cannabis, or hemp-derived cannabinoid products more frequently than 1x/month; positive urine delta-9 tetrahydrocannabinol (THC) test.
• Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease.
• Current use of valproate (due to potential for drug-drug interactions).
• Currently enrolled in other research studies or clinical trials involving therapeutic interventions.
• Subjects with serum transaminase (ALT, AST, and total bilirubin) levels >3 times upper limit of normal (UNL) <24 hours prior to day 1 of treatment.
• Contraindication to MRI such as non-MR conditional medical devices or ferrous retained foreign bodies.