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

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

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05753007
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mclean Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Cannabidiol (CBD) Solution Plus Standard of Care (SOC)

Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment

Placebo Comparator: Placebo

Placebo solution administered for 8 weeks along with standard of care treatment

Interventions

Drug: - Cannabidiol (CBD)

Custom-formulated full-spectrum solution high in cannabidiol

Drug: - Placebo

Placebo solution

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Recruiting

Address

University of California San Francisco Brain Tumor Center

San Francisco, California, 94143

Site Contact

Eduardo Rodriguez Almaraz, MD

[email protected]

415-353-2966