A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
Status:
Not yet recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is
generally considered terminal, patients with GBM often suffer from anxiety and other comorbid
conditions, including depression, pain, and sleep disturbance, all of which significantly
impact their quality of life. Previous studies have demonstrated the potential of
cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without
conferring significant risks or side effects. Further, recent in-vitro and in-vivo work
suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids.
This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial
assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD
product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients
undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor
progression will also be assessed. The proposed clinical trial will provide important
information that does not currently exist regarding the potential efficacy of a novel
full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.
Phase:
Phase 2
Details
Lead Sponsor:
Mclean Hospital
Collaborators:
Center for Medicinal Cannabis Research University of California, San Francisco