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New treatment option for Osteoarthritis, Knee
Official title Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT04992624
What this study is testing
What is Cannabidiol (CBD)?
Cannabidiol (CBD) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Also referred to as Epidiolex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures
- Willingness to participate in a drug intervention trial
- Diagnosis of osteoarthritis (OA) of the knee by a medical provider (confirmed by checking medical records)
- Chronic knee pain, defined as moderate to severe knee pain for ≥ 6-month duration
- No use of cannabis or CBD in the past in the month prior to study enrollment as per self-report
You likely can't join if
- Individuals who are actively applying for or in litigation for compensation or disability and other aspects associated with potential secondary gain...
- Inability to provide written informed consent
- Previous total knee arthroplasty
- Planned total knee arthroplasty within the time frame of the study
- Severe physical impairment (e.g., blindness, deafness, paraplegia)
- Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder)
See the full eligibility criteria
- Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures
- Willingness to participate in a drug intervention trial
- Diagnosis of osteoarthritis (OA) of the knee by a medical provider (confirmed by checking medical records)
- Chronic knee pain, defined as moderate to severe knee pain for ≥ 6-month duration
- No use of cannabis or CBD in the past in the month prior to study enrollment as per self-report
- Fibromyalgia (FM) Survey Criteria score available. The questionnaire will be assessed by the research team for scoring. We will recruit enough patients to satisfy the spectrum of FM scores in four quartiles based on our...
- Self-reported normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing
- No contraindications to magnetic resonance imaging (MRI) (for example (e.g.), metal implants)
- Able to lie still on their back for 1-1.5 hours during MRI
- Willingness to refrain from pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for 12 hours prior to neuroimaging and Quantitative Sensory Testing (QST)
- Willingness to refrain from alcohol and nicotine before QST and neuroimaging (alcohol and nicotine consumption is allowed after testing is completed)
- Willingness to refrain from physical activity or exercise that would cause significant muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is...
- Willingness to maintain a stable treatment regimen for chronic knee OA pain during the clinical trial (e.g., not initiating a new course of physical therapy)
- No use of adjunctive pain medications or stable chronic daily use of adjunctive pain medications (excluding opioids)
- Willingness to avoid grapefruit juice or food products for the duration of the study;
- Females of reproductive potential must agree to use acceptable birth control from the screening visit and until the completion study drug administration. Sexually active male participants and/or their female partners...
- Individuals who are actively applying for or in litigation for compensation or disability and other aspects associated with potential secondary gain per self-report
- Inability to provide written informed consent
- Previous total knee arthroplasty
- Planned total knee arthroplasty within the time frame of the study
- Severe physical impairment (e.g., blindness, deafness, paraplegia)
- Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder)
- Use of cannabis or CBD in the past month per self-report and/or drug screen
- Current opioid use (excepting tramadol) per self-report and/or drug screen
- Current valproate, clobazam, or warfarin use per self-report or medical records
- 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...
- Self-reported allergies to sesame oil or cannabis/cannabinoids
- Self-reported medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., schizophrenia, malignancy, psychosis, suicidal ideation, history of substance...
- Pregnant or nursing
- Liver failure
- Self-reported liver cirrhosis
- Active diagnosis or current symptoms of hepatitis by self-report
- Self-reported uncontrolled diabetes
- Blood pressure at screening above 180 systolic and/or 120 diastolic
- Resting heart rate at screening less than 50 beats per minute (bpm) or greater than 100 bpm;
- Elevated liver enzymes and bilirubin (measured via blood test at screening):
- Serum total bilirubin ≥ 2.5 milligrams per deciliter (mg/dL); or,
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3x upper limit normal (ULN); or,
- Alkaline phosphatase ≥ 2 times ULN
- Severe cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that is self-reported by patient or...
- Severe claustrophobia precluding MRI
- Unable to fit in or lie comfortably in MRI
- Diagnosed peripheral neuropathy
- Diagnosed or self-reported epilepsy or history of seizures
- Current head injury or history of head injury (e.g., traumatic brain injury)
- Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.