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Cannabinoid

CBD for Glioblastoma Anxiety

Phase 2
Recruiting
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Awards & highlights

Summary

This trial will assess the effects of a high CBD product on anxiety, pain, & quality of life in people with GBM, as well as its potential to impact tumor progression.

Who is the study for?
This trial is for adults with newly diagnosed glioblastoma who are fluent in English, have a Karnofsky Performance Scale score of 60 or higher, and experience moderate anxiety. They must be undergoing standard cancer treatment but not using cannabis products more than once a month or participating in other clinical trials.
What is being tested?
The study tests if a high-CBD hemp product can reduce anxiety and improve quality of life in glioblastoma patients during an 8-week trial. It's double-blind, meaning neither the researchers nor participants know who gets CBD or placebo. The effect on tumor growth is also being studied.
What are the potential side effects?
While CBD is generally considered to have few side effects, potential risks may include fatigue, changes in appetite or weight, gastrointestinal issues, and altered liver enzymes. Effects vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Secondary study objectives
Change from Baseline in Pain Assessed by a Visual Analog Scale (VAS)
Change from Baseline in Pain Assessed by the Brief Pain Inventory (BPI)
Change from Baseline in Pain Assessed by the Pain Disability Index (PDI)
+5 more

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375
31%
Diarrhoea
31%
Somnolence
26%
Decreased appetite
18%
Fatigue
15%
Vomiting
15%
Pyrexia
11%
Upper respiratory tract infection
11%
Lethargy
8%
Convulsion
7%
Weight decreased
7%
Gamma-glutamyltransferase increased
7%
Irritability
7%
Cough
7%
Transaminases increased
5%
Status epilepticus
5%
Nasopharyngitis
2%
Oral herpes
2%
Pneumonia
2%
Platelet count
2%
Abdominal distension
2%
Abdominal pain
2%
Gastrointestinal haemorrhage
2%
Asthenia
2%
Lower respiratory tract infection
2%
Gamma-glutamyltransferase
2%
Hypophagia
2%
Hypotonia
2%
Myoclonus
2%
Respiratory failure
2%
Epistaxis
2%
Hypovolaemic shock
2%
Aspartate aminotransferase increased
2%
Liver function test abnormal
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
GWP42003-P 20 mg/kg/Day Dose
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol (CBD) Solution Plus Standard of Care (SOC)Experimental Treatment1 Intervention
Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment
Group II: PlaceboPlacebo Group1 Intervention
Placebo solution administered for 8 weeks along with standard of care treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol (CBD)
2021
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,551 Previous Clinical Trials
15,257,850 Total Patients Enrolled
21 Trials studying Glioblastoma
4,109 Patients Enrolled for Glioblastoma
Mclean HospitalLead Sponsor
215 Previous Clinical Trials
21,657 Total Patients Enrolled
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
593 Total Patients Enrolled

Media Library

Cannabidiol (CBD) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05753007 — Phase 2
Glioblastoma Research Study Groups: Placebo, Cannabidiol (CBD) Solution Plus Standard of Care (SOC)
Glioblastoma Clinical Trial 2023: Cannabidiol (CBD) Highlights & Side Effects. Trial Name: NCT05753007 — Phase 2
Cannabidiol (CBD) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753007 — Phase 2
~22 spots leftby Sep 2025
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