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

Last updated: March 26, 2025
Sponsor: Mclean Hospital
Overall Status: Terminated

Phase

2

Condition

Gliomas

Astrocytoma

Treatment

Placebo

Cannabidiol (CBD)

Clinical Study ID

NCT05753007
23-38341
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of newly diagnosed glioblastoma, evidenced by neuropathology reportand based on World Health Organization (WHO) 2021 classification, and who are toundergo SOC (~ 6 weeks of treatment) with radiation and temozolomide (patients usingOptune may be included).

  • Written informed consent obtained from subject or subject's legal representative andability 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 screeningvisit

  • Stable medication/psychotherapy regimens for at least 1 month prior to starting thestudy (excluding new glioblastoma treatment-related medications or radiation).

  • Karnofsky Performance Scale (KPS) of 60 or higher.

Exclusion

Exclusion Criteria:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participationin the study.

  • Presence of a condition or abnormality that in the opinion of the Investigatorswould compromise the safety of the patient or the quality of the data.

  • Current substance use disorder, psychotic disorder, bipolar disorder, or eatingdisorder.

  • Current use of recreational cannabis, medical cannabis, or hemp-derived cannabinoidproducts more frequently than 1x/month; positive urine delta-9 tetrahydrocannabinol (THC) test.

  • Presence of a serious or unstable medical illness, including liver, kidney, orcardiovascular disease.

  • Current use of valproate (due to potential for drug-drug interactions).

  • Currently enrolled in other research studies or clinical trials involvingtherapeutic interventions.

  • Subjects with serum transaminase (ALT, AST, and total bilirubin) levels >3 timesupper limit of normal (UNL) <24 hours prior to day 1 of treatment.

  • Contraindication to MRI such as non-MR conditional medical devices or ferrousretained foreign bodies.

Study Design

Total Participants: 2
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 15, 2024
Estimated Completion Date:
February 11, 2025

Connect with a study center

  • University of California San Francisco Brain Tumor Center

    San Francisco, California 94143
    United States

    Site Not Available

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