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NCT05753007 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
A Phase 2 study, sponsored by Mclean Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT05753007: Clinical Trial Phase 2 study, sponsored by Mclean Hospital.
NCT05753007 is a Phase 2 study that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05753007, a Phase 2 study, was terminated before completion, sponsored by Mclean Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Cannabidiol (CBD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-02-15 |
| Est. Completion | 2025-02-11 |
| Phase | Phase 2 |
Why NCT05753007 stopped before completion
NCT05753007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05753007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05753007 about?
NCT05753007 is a clinical study titled "A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients". 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 o...
What is the current status of trial NCT05753007?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2024-02-15. Estimated completion is 2025-02-11.
What interventions are being tested in trial NCT05753007?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (CBD) (DRUG).
Who is sponsoring clinical trial NCT05753007?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05753007's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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