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Cannabinoid
CBD + THC for Knee Osteoarthritis
Phase 2
Recruiting
Led By Richard Harris, PhD
Research Sponsored by Richard Harris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic knee pain, defined as moderate to severe knee pain for ≥ 6-month duration
Diagnosis of osteoarthritis (OA) of the knee by a medical provider (confirmed by checking medical records)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, and approximately day 99 of treatment
Awards & highlights
Study Summary
This trial is testing how different doses of THC, CBD, or a combination of the two affects knee pain and other symptoms related to osteoarthritis.
Who is the study for?
This trial is for English-speaking, right-handed adults with knee osteoarthritis who haven't used cannabis or CBD in the past month. They must be able to lie still for MRI scans and refrain from certain activities and medications before testing. Pregnant women, those planning knee surgery, or individuals with severe physical impairments or specific medical conditions are excluded.Check my eligibility
What is being tested?
The study tests how daily treatment with THC (Tetrahydrocannabinol), CBD (Cannabidiol), their combination, or a placebo affects pain from knee osteoarthritis over approximately 18 weeks. Participants will undergo clinical assessments, blood draws, questionnaires, pain diaries, sensory testing, and brain imaging without knowing which treatment they receive.See study design
What are the potential side effects?
Potential side effects of THC and CBD may include changes in appetite or mood swings; dizziness; dry mouth; altered mental state; gastrointestinal discomfort like nausea; fatigue; potential interaction with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had knee pain that is moderate to severe for 6 months or more.
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My doctor confirmed I have knee osteoarthritis.
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I can stay still on my back for up to 1.5 hours.
Select...
I am not using new pain medications or have been on a stable dose of non-opioid pain meds.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15, and approximately day 99 of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15, and approximately day 99 of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pre-post measurements of inflammatory marker IL-6.
Default mode network (DMN) to insula connectivity via functional connectivity magnetic resonance imaging (fcMRI)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tetrahydrocannabinol (THC)Experimental Treatment1 Intervention
Up to 10 mg/day.
Group II: Cannabidiol (CBD)Experimental Treatment1 Intervention
Up to 150 mg/day.
Group III: CBD plus THCExperimental Treatment2 Interventions
Up to 150 mg/day CBD plus up to 10 mg/day THC.
Group IV: PlaceboPlacebo Group1 Intervention
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?
Richard HarrisLead Sponsor
Steven E Harte, PhDLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,734 Total Patients Enrolled
22 Trials studying Osteoarthritis
5,152 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking valproate, clobazam, or warfarin.I have used cannabis or CBD in the last month.I have epilepsy or a history of seizures.I am allergic to sesame oil or cannabis products.I have a current or past head injury.I agree to use birth control during and after the study.I am not taking, nor will I start taking, certain strong medications that affect liver enzymes during the study.I have had knee pain that is moderate to severe for 6 months or more.I do not have any health or mental conditions that would stop me from joining this study.I do not have serious health conditions that could affect my physical ability.You are able to read and speak English.I have been diagnosed with liver cirrhosis.I have been diagnosed with nerve damage in my hands or feet.I have had a total knee replacement surgery.I am scheduled for a knee replacement during the study period.I have a severe physical impairment like blindness or deafness.My liver is not working properly.I currently have or am experiencing symptoms of hepatitis.I have diabetes that is not well-managed.I cannot comfortably fit or lie in an MRI machine.I agree not to start new treatments for my knee pain during the trial.I am currently using opioids, not including tramadol.I have severe heart problems, such as heart attacks or heart failure.Nothing will stop me from completing the study as required.You have a strong fear of small, enclosed spaces that would make it difficult for you to have an MRI scan.My doctor confirmed I have knee osteoarthritis.My vision is normal or correctable to at least 20/40 with glasses or contacts.I can stay still on my back for up to 1.5 hours.I can avoid taking painkillers like ibuprofen and acetaminophen for 12 hours before certain tests.I am not using new pain medications or have been on a stable dose of non-opioid pain meds.You are willing to take part in a study involving new medications.You agree not to consume grapefruit juice or foods that contain grapefruit for the entire study period.I haven't used cannabis or CBD in the last month.You are right-handed.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol (CBD)
- Group 2: Tetrahydrocannabinol (THC)
- Group 3: CBD plus THC
- Group 4: Placebo
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the possible dangers associated with taking Cannabidiol (CBD)?
"There is some evidence backing CBD's safety, but its efficacy has not been studied yet. Therefore, it received a score of 2."
Answered by AI
Does this clinical trial have an age requirement? If so, what is it?
"According to the listed eligibility requirements, patients who wish to participate in this trial must be between 21 and 75 years old. In contrast, there are 52 trials for patients under 18 and 757 for people over 65."
Answered by AI
Which benefits of CBD have been most popular among patients?
"Cannabidiol (CBD) can help patients who have failed to respond to conventional therapy, have multiple sclerosis, or are being treated with pharmacotherapy."
Answered by AI
Are there any other ongoing research projects studying Cannabidiol (CBD)?
"There are a total of 113 studies being conducted that focus on Cannabidiol (CBD). Out of those, 21 are large-scale Phase 3 trials. The majority of research teams for this treatment are based in Belmont, Massachusetts; However, there are 357 locations worldwide where clinical trials related to CBD are taking place."
Answered by AI
How do I qualify to participate in this research study?
"The requirements for this study are that patients have a diagnosis of osteoarthritis, knee pain, and be between 21-75 years old. They will also need to not have any other major health concerns. Around 200 people are needed for the clinical trial."
Answered by AI
Are new volunteers being taken in for this trial?
"This study, which can be found on clinicaltrials.gov, is looking for patients at the moment. It was first posted on February 22nd, 2022 and last updated on October 30th, 2022."
Answered by AI
How many people are being welcomed into this clinical trial?
"This is accurate. The information available on clinicaltrials.gov show that this study, which was initially advertised on February 22nd 2022, still needs participants. In total, they are looking for 200 patients from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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