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

NCT05753007 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 23-38341
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)

  The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3 (higher scores indicating more anxiety). The full score range is 0-63.

  8 weeks

• Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)

  The OASIS is a brief 5-item measure used to evaluate the functional impairment cause by anxiety; the frequency and intensity of anxiety, as well as the degree of avoidance and interference with work and social function are rated on a scale of 0 to 4. Total scores range from 0-20 (higher scores indicating more anxiety).

  8 weeks

Secondary Outcomes (4)

• Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS)

  8 weeks

• Change From Baseline in Pain Assessed by the Pain Disability Index (PDI)

  8 weeks

• Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• Patient's Global Impression of Change (PGIC) at Follow-Up

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Cannabidiol (CBD)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

Placebo solution

Placebo

Cannabidiol (CBD) DRUG

Custom-formulated full-spectrum solution high in cannabidiol

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• Center for Medicinal Cannabis Research: collaborator
• Mclean Hospital: lead

Study Sites (1)

University of California San Francisco Brain Tumor Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

This study was terminated prior to completion, and as such, statistical analyses could not be conducted due to low enrollment in each group.

Results Point of Contact

• Title: Staci Gruber, PhD.
• Organization: McLean Hospital

gruber@mclean.harvard.edu

617-855-2762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 3, 2023
• Study Start: February 15, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-02

Locations

US (1)