GlioblastomaPhase 2NCT05753007
A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
A Phase 2 study testing Cannabidiol (CBD) in people with Glioblastoma, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Cannabidiol (CBD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 11 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Brain Tumor Center
San Francisco, California, 94143
About this study
Official title: A Randomized, Double-blind, 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 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
- Being tested
- Cannabidiol (CBD), Placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Custom-formulated full-spectrum solution high in cannabidiol
PlaceboDrug
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cannabidiol (CBD) |
| Placebo | Placebo comparator | Placebo solution administered for 8 weeks along with standard of care treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 8 weeks
Secondary outcomes (4)
Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS)
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.
Measured: 8 weeks
Change From Baseline in Pain Assessed by the Pain Disability Index (PDI)
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.
Measured: 8 weeks
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
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).
Measured: 8 weeks
Patient's Global Impression of Change (PGIC) at Follow-Up
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start15 Feb 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: Study terminated by sponsor due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Center for Medicinal Cannabis Research
- Responsible party
- Principal investigator, Staci Gruber, Ph.D., Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753007
- Sponsor's protocol ID
- 23-38341
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2023
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT05753007
- Acronym / sponsor ID
- 23-38341
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by sponsor due to low enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Center for Medicinal Cannabis Research
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) Solution Plus Standard of Care (SOC) | Experimental | Drug: Cannabidiol (CBD)Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution administered for 8 weeks along with standard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Custom-formulated full-spectrum solution high in cannabidiol | Drug | Cannabidiol (CBD) Solution Plus Standard of Care (SOC) |
| PlaceboPlacebo solution | Drug | Placebo |
Primary outcome
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
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.
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
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).
4 secondary outcomes
Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS)
Time frame: 8 weeks
Change From Baseline in Pain Assessed by the Pain Disability Index (PDI)
Time frame: 8 weeks
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Patient's Global Impression of Change (PGIC) at Follow-Up
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol (CBD) in people with Glioblastoma, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.