Trial Outcomes & Findings for A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients (NCT NCT05753007)

Last Updated: 2026-03-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-03-16

Participant Flow

Patients were randomized following the baseline visit, once eligibility was determined.

Participant milestones

Participant milestones
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo Placebo solution administered for 8 weeks along with standard of care treatment
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment	Total n=2 Participants Total of all reporting groups
Age, Continuous	64 Years n=10 Participants	49 Years n=50 Participants	56.5 Years n=108 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	0 Participants n=50 Participants	1 Participants n=108 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	1 Participants n=50 Participants	1 Participants n=108 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Race (NIH/OMB) White	1 Participants n=10 Participants	1 Participants n=50 Participants	2 Participants n=108 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=10 Participants	1 Participants n=50 Participants	2 Participants n=108 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants
Karnofsky Performance Status (KPS)	90 Score n=10 Participants	90 Score n=50 Participants	90 Score n=108 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) Baseline BAI Score	18 Score Interval 18.0 to 18.0	10 Score Interval 10.0 to 10.0
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) Week 8 BAI Score	16 Score Interval 16.0 to 16.0	1 Score Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) Baseline OASIS Score	5 Score Interval 5.0 to 5.0	11 Score Interval 11.0 to 11.0
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) Week 8 OASIS Score	4 Score Interval 4.0 to 4.0	2 Score Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS) Baseline PDS Score	1 Score Interval 1.0 to 1.0	1 Score Interval 1.0 to 1.0
Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS) Week 8 PDS Score	1 Score Interval 1.0 to 1.0	0 Score Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Change From Baseline in Pain Assessed by the Pain Disability Index (PDI) Baseline PDI Score	3 Score Interval 3.0 to 3.0	5 Score Interval 5.0 to 5.0
Change From Baseline in Pain Assessed by the Pain Disability Index (PDI) Week 8 PDI Score	6 Score Interval 6.0 to 6.0	0 Score Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) Baseline PSQI Score	12 Score Interval 12.0 to 12.0	4 Score Interval 4.0 to 4.0
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) Week 8 PSQI Score	8 Score Interval 8.0 to 8.0	2 Score Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 8 weeks

Population: As the PGIC reflects scores relative to baseline, it is not administered at baseline and only 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.

Outcome measures

Outcome measures
Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 Participants Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 Participants Placebo solution administered for 8 weeks along with standard of care treatment
Patient's Global Impression of Change (PGIC) at Follow-Up	2 Score Interval 2.0 to 2.0	2 Score Interval 2.0 to 2.0

Adverse Events

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

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Staci Gruber, PhD.

McLean Hospital

Phone: 617-855-2762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cannabidiol (CBD) Solution Plus Standard of Care (SOC) n=1 participants at risk Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment	Placebo n=1 participants at risk Placebo solution administered for 8 weeks along with standard of care treatment
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Renal and urinary disorders Increased urinary frequency	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Skin and subcutaneous tissue disorders Alopecia	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Cardiac disorders Sinus bradycardia	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Vascular disorders Hypertension	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Endocrine disorders Decreased ALC	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Blood and lymphatic system disorders Decreased WBC	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.
Ear and labyrinth disorders Tinnitus	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Gastrointestinal disorders Heartburn	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Nervous system disorders Dizziness	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Nervous system disorders Seizure	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Nervous system disorders Amnesia	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Psychiatric disorders Euphoria	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Hepatobiliary disorders Increased AST	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.
Hepatobiliary disorders Increased ALT	100.0% 1/1 • From enrollment until end of trial, up to 8 weeks.	0.00% 0/1 • From enrollment until end of trial, up to 8 weeks.