Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
Eligible age
21–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).
Sponsor: Steven E Harte, PhD
You may qualify 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
- ✓ 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 previously existing data. Once a quartile is filled (approximately 40 patients enrolled), then we will not include more people from that quartile.
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Ann Arbor
Source: ClinicalTrials.gov · NCT04992624 · last updated 2025-09-02