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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)
Must not have
Current use of moderate or strong inhibitors of cytochrome p450 (CYP) enzymes CYP3A4 and CYP2C19, strong inducers of CYP3A4 or CYP2C19, moderate or strong inhibitors/inducers of CYP2C9, and narrow therapeutic index drugs (e.g., cyclosporine, amphotericin B). Participants will also not be allowed to start using these drugs during the study period if they wish to stay in the study
Current valproate, clobazam, or warfarin use per self-report or medical records
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, and approximately day 99 of treatment
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.
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.
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.
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I am not using new pain medications or have been on a stable dose of non-opioid pain meds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking, nor will I start taking, certain strong medications that affect liver enzymes during the study.
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I am currently taking valproate, clobazam, or warfarin.
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I have used cannabis or CBD in the last month.
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I have epilepsy or a history of seizures.
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I am allergic to sesame oil or cannabis products.
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I have a current or past head injury.
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I have been diagnosed with liver cirrhosis.
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I have been diagnosed with nerve damage in my hands or feet.
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I have had a total knee replacement surgery.
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I am scheduled for a knee replacement during the study period.
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I have a severe physical impairment like blindness or deafness.
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My liver is not working properly.
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I currently have or am experiencing symptoms of hepatitis.
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I have diabetes that is not well-managed.
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I cannot comfortably fit or lie in an MRI machine.
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I am currently using opioids, not including tramadol.
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I have severe heart problems, such as heart attacks or heart failure.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
854 Previous Clinical Trials
671,560 Total Patients Enrolled
23 Trials studying Osteoarthritis
5,634 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.
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