CBD Knee Osteoarthritis Study

NCT07638189 | Not Yet Recruiting Phase 2

• 1 other identifier: STUDY00000389
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis of the knee is a common cause of pain in the US. The currently available medicines for knee osteoarthritis sometimes are not effective at relieving the pain or have unacceptable side effects. Thus, alternate pain relieving treatments are needed. CBD, an active chemical from the hemp derived cannabis sativa plant, has received a lot of attention for its potential pain relieving properties, but there has been limited research to find out if topically applied CBD can decrease pain from knee osteoarthritis. CBD lacks the psychoactive effects seen with marijuana use, because it does not contain THC which is responsible for those effects in marijuana. It is legal to use CBD in the State of Tennessee (site of study). The CBD Knee Study is sponsored by the University of Tennessee Health Science Center and is a collaborative effort between doctors at UT and Campbell Clinic. In the CBD Knee Study, the investigators are examining whether topically applied CBD dissolved in Castor Oil will relieve knee pain in persons with knee osteoarthritis. Persons who take part in the study would need to come for study visits, fill out questionnaires about their health and knee pain, and would be asked to use the topical study oil on their knees. Taking part in the CBD Knee Study is voluntary.

Conditions

Osteoarthitis

Keywords

Randomized Clinical Trial; Cannabidiol (CBD); Knee Pain

Outcome Measures

Primary Outcomes (1)

• Knee Pain

  The investigators will use ecological momentary assessment to collect knee pain scores and develop pain trajectories. A Visual Analog Scale of Self-Reported Pain will be assessed at study visits and up to once a day via text message using the Wong-Baker visual analogue scale. A score of 0 is no pain and a score of 10 is severe pain. Please note this is crossover clinical trial and there are 2 Baseline Visits (One and Two). Knee Pain will be assessed at the Screening Visit as an eligibility criteria and at Baseline One Visit (Day 1), Follow-up One Visit (Day 30), Baseline Two Visit (Day 44), and Follow-up Two Visit (Day 74). The Baseline One Visit will occur 2 weeks after the Screening Visit. Change in knee pain scores on the Visual Analog Scale of Self-Reported Pain will be assessed from the Baseline One Visit to the the Follow-up One Visit and from the Baseline Two Visit to the the Follow-up Two Visit.

  Day 1 - Baseline One Visit, Day 30 - Follow-up One Visit, Day 44 - Baseline Two Visit, and Day 74 - Follow-up Two Visit

Secondary Outcomes (2)

• Sleep

  Day 1 - Baseline One Visit, Day 30 - Follow-up One Visit, Day 44 - Baseline Two Visit, and Day 74 - Follow-up Two Visit

• Knee Related Quality of Life and Function

  Day 1 - Baseline One Visit, Day 30 - Follow-up One Visit, Day 44 - Baseline Two Visit, and Day 74 - Follow-up Two Visit

Other Outcomes (2)

• Adherence with Study Medication

  Day 1 - Baseline One Visit, Day 30 - Follow-up One Visit, Day 44 - Baseline Two Visit, and Day 74 - Follow-up Two Visit

• Adherence with Study Medication by Self-report

  From enrollment at Day 1 to the end of treatment at Day 74

Study Arms (2)

CBD+Castol Oil

ACTIVE COMPARATOR

250 mg CBD dissolved in 1 ml of Castor Oil to be applied topically to the knee BID

Dietary Supplement: Cannabidiol (CBD)

Castor Oil Alone

PLACEBO COMPARATOR

1 ml of Castor Oil Alone applied topically to the knee as the placebo comparator BID

Other: Castor Oil (Placebo)

Interventions

Cannabidiol (CBD) DIETARY_SUPPLEMENT

250 mg of CBD will be dissolved in 1 ml of Castor Oil. Participants will use 1ml of this solution on each knee BID

CBD+Castol Oil

Castor Oil (Placebo) OTHER

1 ml of Castor oil alone will be applied to each knee BID as the placebo

Castor Oil Alone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee OA (grade 2-3 as measured by the Kellgren-Lawrence Classification)
• OA knee pain on the Visual Analog Pain Scale \> 4 in either knee
• Receiving treatment at one of the eight Campbell Clinic Orthopaedics locations

You may not qualify if:

• Other forms of arthritis such as psoriatic arthritis or rheumatoid arthritis due to different sources of inflammation in these conditions
• Allergies to CBD or Castor Oil
• Current opioid use
• BMI of over 40
• Those who cannot walk without an assistance device (e.g., walker)
• Those who are currently on knee injections (i.e. cortisol or hyaluronic acid gel) for knee pain
• Patients scheduled for a knee replacement in the next 3-6 months
• Active cannabis or CBD use
• Alcohol consumption \> 21 alcoholic drinks each week
• Active pregnancy, nursing, or actively planning a pregnancy
• Active chronic liver or renal disease
• Active depression/suicidality
• Medications that interact with CBD in the liver that cannot be discontinued 14. Discretion of the Multiple Principal Investigators for concerns regarding noncompliance with the study intervention.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

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MeSH Terms

Interventions

Cannabidiol; Castor Oil

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Karen C Johnson, MD, MPH

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Derefinko, PhD

CONTACT

901-448-5900; kderefin@uthsc.edu

William Mihalko, MD, PhD

CONTACT

901-448-2666; wmilhalko@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators will conduct a pilot randomized crossover clinical trial (RCT) to examine the analgesic efficacy and safety of CBD+Castor Oil compared to a Castor Oil alone, in 30 patients with knee OA pain. Eligible participants will be randomized in a 1:1 fashion to either 1) CBD+Castor Oil followed by Castor Oil alone; or 2) Castor Oil alone followed by CBD+Castor Oil with a 2-week washout period between the treatment periods. Each oil will be used for a total of 1 month.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)