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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks
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 moreTrial 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
2,587 Previous Clinical Trials
14,901,140 Total Patients Enrolled
Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,837 Total Patients Enrolled
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
593 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses like heart, liver, or kidney diseases.I use cannabis or related products more than once a month.I am currently taking valproate.My medication or therapy for conditions other than glioblastoma has been stable for at least 1 month.I have a new diagnosis of glioblastoma and am following the standard treatment plan.I can care for myself but may need occasional help.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cannabidiol (CBD) Solution Plus Standard of Care (SOC)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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