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Trial Title:
A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
NCT ID:
NCT05753007
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Cannabidiol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Cannabidiol (CBD)
Description:
Custom-formulated full-spectrum solution high in cannabidiol
Arm group label:
Cannabidiol (CBD) Solution Plus Standard of Care (SOC)
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo solution
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Francisco Brain Tumor Center
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eduardo Rodriguez Almaraz, MD
Phone:
415-353-2966
Email:
eduardo.rodriguez@ucsf.edu
Investigator:
Last name:
Nicholas Butowski, MD
Email:
Principal Investigator
Start date:
February 15, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Mclean Hospital
Agency class:
Other
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Center for Medicinal Cannabis Research
Agency class:
Other
Source:
Mclean Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753007
