← Back to Search

Cannabinoid

CBD for Glioblastoma Anxiety

Q: How risky is it to use Cannabidiol (CBD) Solution Plus Standard of Care (SOC)?

<p>The safety of Cannabidiol (<a href="https://www.withpower.com/clinical-trials/cbd">CBD</a>) Solution Plus Standard of Care (SOC) was assessed as a 2 due to the Phase 2 trial data. This suggests that while there is some evidence for safety, efficacy has yet to be proven.</p>

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

Study 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.Check my eligibility

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.See study design

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Convulsion

Weight decreased

Gamma-glutamyltransferase increased

Irritability

Cough

Transaminases increased

Status epilepticus

Nasopharyngitis

Pneumonia

Oral herpes

Platelet count

Abdominal distension

Abdominal pain

Gastrointestinal haemorrhage

Asthenia

Lower respiratory tract infection

Gamma-glutamyltransferase

Hypophagia

Hypotonia

Myoclonus

Respiratory failure

Epistaxis

Hypovolaemic shock

Aspartate aminotransferase increased

Liver function test abnormal

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

GWP42003-P 20 mg/kg/Day Dose

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,507 Previous Clinical Trials

15,238,539 Total Patients Enrolled

21 Trials studying Glioblastoma

4,085 Patients Enrolled for Glioblastoma

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,658 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial currently open?

"According to the clinicaltrials.gov entry, this trial is no longer seeking participants as it was last updated on February 21st 2023. However, there are 449 other medical studies currently inviting enrolment from volunteers."

Answered by AI

How risky is it to use Cannabidiol (CBD) Solution Plus Standard of Care (SOC)?

"The safety of Cannabidiol (CBD) Solution Plus Standard of Care (SOC) was assessed as a 2 due to the Phase 2 trial data. This suggests that while there is some evidence for safety, efficacy has yet to be proven."

Answered by AI

What are the desired effects of this experiment?

"This clinical trial, conducted over 8 weeks, will measure the reduction in anxiety levels using the Overall Anxiety Severity and Impairment Scale (OASIS). Secondary objectives include gauging pain relief via Visual Analog Scale (VAS) which is a 100mm line with 0-100 mm being designated to signify level of discomfort; Pain Distress Scale (PDS), an 11 point scale that scores patients on how much distress their condition causes them; as well as assessing disability due to pain by measuring usage of Pain Disability Index (PDI)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Staci Gruber, Ph.D. 2024. "A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753007.

All > Cbd > Epidiolex