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Cannabinoid
Cannabidiol for Chronic Pain
Phase 2
Recruiting
Research Sponsored by Staci Gruber, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is 21 or older
Subject endorses a chronic pain condition including chronic pain due to injury, musculoskeletal pain, arthritis (including osteoarthritis and rheumatoid arthritis), fibromyalgia, bursitis, endometriosis, etc.
Must not have
Non-fluent English speakers
History of head injury or loss of consciousness greater than 5 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Summary
This trial will test a CBD product for 9 weeks on people with chronic pain to see if it helps reduce pain, medication use, and improve quality of life and other health markers.
Who is the study for?
This trial is for adults over 21 who speak English fluently and suffer from chronic pain, which could be due to injury, arthritis, fibromyalgia, bursitis, endometriosis or similar conditions. Participants must consent to join the study.
What is being tested?
The trial tests a high-CBD sublingual product against a placebo over 9 weeks to see its effects on chronic pain symptoms, medication use, overall health status, life quality, thinking abilities and biological markers.
What are the potential side effects?
Potential side effects of CBD may include tiredness, diarrhea or changes in appetite/weight. However specific side effects related to this high-CBD product will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I have a long-term pain condition like arthritis or fibromyalgia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not fluent in English.
Select...
I have had a head injury or was unconscious for more than 5 minutes.
Select...
I regularly use CBD products.
Select...
I am not pregnant, trying to conceive, or breastfeeding.
Select...
I do not have serious illnesses like heart, liver, kidney diseases, or seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain ratings on a Numerical Rating Scale (NRS)
Secondary study objectives
Change in Conventional Medication Use
Change in pain ratings on the Brief Pain Inventory (BPI)
Change in ratings on the Pain Disability Index (PDI)
+2 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol Treatment ArmExperimental Treatment1 Intervention
High-CBD sublingual product administered three times daily for the treatment period.
Group II: Placebo Treatment ArmPlacebo Group1 Intervention
Placebo sublingual product administered three times daily for the treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
Staci Gruber, Ph.D.Lead Sponsor
1 Previous Clinical Trials
97 Total Patients Enrolled
Etheridge FoundationUNKNOWN
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Chronic Pain
10 Patients Enrolled for Chronic Pain