Cannabidiol (CBD)
Custom-formulated full-spectrum solution high in cannabidiol
Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-03-16
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Custom-formulated full-spectrum solution high in cannabidiol
Placebo solution
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 18 | 18 to 18 |
| Placebo | 1 | 10 | 10 to 10 |
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 16 | 16 to 16 |
| Placebo | 1 | 1 | 1 to 1 |
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).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 5 | 5 to 5 |
| Placebo | 1 | 11 | 11 to 11 |
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 4 | 4 to 4 |
| Placebo | 1 | 2 | 2 to 2 |
The PDS is an 11-point scale one where patients rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 1 | 1 to 1 |
| Placebo | 1 | 1 | 1 to 1 |
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 1 | 1 to 1 |
| Placebo | 1 | 0 | 0 to 0 |
On the PDI, the patient rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". The total score ranges from 0-70, with lower scores indicating less disability.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 3 | 3 to 3 |
| Placebo | 1 | 5 | 5 to 5 |
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 6 | 6 to 6 |
| Placebo | 1 | 0 | 0 to 0 |
The PSQI contains 19 self-rated questions that assess sleep quality and disturbance over the previous 1-month period. The 19 items yield seven component scores such as sleep latency, sleep duration, and daytime dysfunction, which are then summed to generate a global score from 0 to 21 (higher scores indicating lower sleep quality).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 12 | 12 to 12 |
| Placebo | 1 | 4 | 4 to 4 |
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 8 | 8 to 8 |
| Placebo | 1 | 2 | 2 to 2 |
The PGIC is a single-question, 7-point scale (total score range: 1-7) depicting a patient's rating of overall improvement from "very much worse" to "very much improved", with higher scores indicating greater improvement.
Population: As the PGIC reflects scores relative to baseline, it is not administered at baseline and only at follow-up.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | 1 | 2 | 2 to 2 |
| Placebo | 1 | 2 | 2 to 2 |
Patients were randomized following the baseline visit, once eligibility was determined.
| Milestone | Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | Placebo |
|---|---|---|
| STARTED | 1 | 1 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 1 / 1 |
| Increased urinary frequency | Renal and urinary disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 0 / 1 · Placebo: 1 / 1 |
| Alopecia | Skin and subcutaneous tissue disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 1 / 1 |
| Sinus bradycardia | Cardiac disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 0 / 1 · Placebo: 1 / 1 |
| Hypertension | Vascular disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 0 / 1 · Placebo: 1 / 1 |
| Decreased ALC | Endocrine disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 1 / 1 |
| Decreased WBC | Blood and lymphatic system disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 0 / 1 · Placebo: 1 / 1 |
| Tinnitus | Ear and labyrinth disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Heartburn | Gastrointestinal disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Dizziness | Nervous system disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Seizure | Nervous system disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Amnesia | Nervous system disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Euphoria | Psychiatric disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Increased AST | Hepatobiliary disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
| Increased ALT | Hepatobiliary disorders | Cannabidiol (CBD) Solution Plus Standard of Care (SOC): 1 / 1 · Placebo: 0 / 1 |
Eligibility
primary outcomes
Time frame: 8 weeks
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.
Time frame: 8 weeks
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).
secondary outcomes
Time frame: 8 weeks
The PDS is an 11-point scale one where patients rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.
Time frame: 8 weeks
On the PDI, the patient rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". The total score ranges from 0-70, with lower scores indicating less disability.
Time frame: 8 weeks
The PSQI contains 19 self-rated questions that assess sleep quality and disturbance over the previous 1-month period. The 19 items yield seven component scores such as sleep latency, sleep duration, and daytime dysfunction, which are then summed to generate a global score from 0 to 21 (higher scores indicating lower sleep quality).
Time frame: 8 weeks
The PGIC is a single-question, 7-point scale (total score range: 1-7) depicting a patient's rating of overall improvement from "very much worse" to "very much improved", with higher scores indicating greater improvement.
Publications
No exact PMID-linked public article is currently readable locally.