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

Summary

The proposed investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived product (study product) in patients with glioblastoma. Despite the recent interest in medicinal cannabis (MC) and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, no studies have conducted a clinical trial of a hemp-derived product in these patients despite their reported levels of anxiety.

This is a randomized, double-blind, placebo-controlled study designed to examine the impact of a custom-formulated, high CBD product on measures of anxiety, quality of life, and tumor progression and imaging stability in newly-diagnosed glioblastoma patients. The custom formulation contains approximately 250 mg/ml of CBD and 1.8 mg/ml THC, along with several other cannabinoids.

Inclusion Criteria
  1. Male or female ≥ 18 years of age
  2. Documentation of newly diagnosed GBM, evidenced by neuropathology report and based on WHO 2021 classification, and who are to undergo SOC with radiation and Temodar (patients using Optune may be included)
  3. Written informed consent obtained from patient or patient’s legal representative and ability for patient to comply with the requirements of the study
  4. Fluent in English
  5. Scores a minimum of 16 on the Beck Anxiety Inventory (BAI) OR a minimum of 11 on the Overall Anxiety Severity and Impairment Scale (OASIS) at the screening visit
  6. Stable medication/psychotherapy regimens for at least 1 month prior to starting the study (excluding new glioblastoma treatment-related medications or radiation)
  7. KPS of 60 or higher
Exclusion Criteria
  1. Pregnant, breastfeeding, or unwilling to practice birth control during study participation
  2. 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
  3. Current substance use, psychotic, bipolar, or eating disorder
  4. Current use of recreational cannabis, medical cannabis, or hemp-derived cannabinoid products more frequently than 1x/month; positive urine THC test
  5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease
  6. Current use of valproate (due to potential for drug-drug interactions)
  7. Currently enrolled in another research study/clinical trial involving therapeutic intervention
  8. Serum transaminase (ALT, AST, and total bilirubin) levels >3 times UNL less than 24 hours prior to day 1 of treatment
  9. Contraindications to MRI, such as non-MR conditional medical devices or ferrous retained foreign bodies
Investigator(s)

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