RECRUITING

CBD for Knee Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Osteoarthritis is a disease that affects millions of Americans and is the leading cause of persistent pain and physical disability in the older adult population. Many physically active Americans have reported pain-relieving effects of cannabidiol (CBD) that can reduce or eliminate use of nonsteroidal anti-inflammatory drugs (NSAIDs) for activity-related pain with minimal to no side effects. Long-term use of over-the-counter medications, including NSAIDs, can pose a significant health risk, and therefore clinical research on the safety and efficacy of CBD is needed.

Official Title

Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis

Quick Facts

Study Start:2024-06-14
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06414473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. established clinical diagnosis of knee osteoarthritis (KOA)
  2. 2. moderate to severe knee pain (≥4/10) with physical activity in one or both knees
  1. 1. pregnant (urine pregnancy test) or lactating
  2. 2. current cannabis (THC and/or CBD) use (urine drug screen)
  3. 3. any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject
  4. 4. any major surgery within 3 months prior to recruitment or planned orthopedic surgery for any time during this study which would interfere with the ability to report pain or quality of life outcome measures
  5. 5. any exposure to another investigational drug within 3 months prior to screening
  6. 6. BMI ≥ 45
  7. 7. current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes
  8. 8. history of:
  9. 1. suicidal ideation or self-harm behavior
  10. 2. seizure disorder or traumatic brain injury,
  11. 3. liver or kidney disease, and
  12. 4. cardiovascular diseases

Contacts and Locations

Study Contact

Paul A. Borsa, PhD
CONTACT
352-294-1726
pborsa@ufl.edu
John W Stauffer, MS
CONTACT
352-294-1777
johnstauffer@ufl.edu

Study Locations (Sites)

Sports Medicine Research Laboratory
Gainesville, Florida, 32601
United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-14
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-06-14
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cannabidiol
  • Osteoarthritis
  • Pain
  • Dysfunction
  • Physical Activity

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee