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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 is a Phase 2 study that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753007
The ClinicalTrials.gov registry entry for NCT05753007 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05753007 reports 0 study locations.
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.
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