- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06414473
CBD for Knee Osteoarthritis (SLACK-OA)
May 14, 2024 updated by: University of Florida
Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Knee OA is the most common joint disease and a major cause of functional limitation and pain in adults.
Pain is the primary symptom of OA, and the main reason people seek medical treatment.
Although pharmacologic treatment for OA such as opioid-based medications may help in the short-term with reducing pain-related symptoms, they are known to have mild to severe side effects along with the potential for long-term dependency.
Consequently, many Americans have turned to cannabis-related products like cannabidiol or CBD for reducing pain and pain-related symptoms associated with OA.
Current research has shown evidence that phyto-cannabinoids may have a promising therapeutic potential in a variety of physical and psychological ailments, and cannabidiol (CBD) is of particular interest due to its positive safety profile, non-intoxicating effects, and purported therapeutic capabilities in several musculoskeletal diseases.
In vitro and in vivo studies have shown that CBD administration in the short term is safe and effective in reducing inflammation and pain behaviors in animal models of OA.
Despite the widespread popularity of CBD in the US, there is very limited data that indicates the safety, acceptability, and pain-relieving effects of CBD use for people with symptomatic knee osteoarthritis.
The investigators' objective will be to conduct an early-stage clinical trial to investigate the safety, tolerability/acceptability, and efficacy of CBD as a non-pharmacological treatment for symptomatic knee OA.
The investigators will conduct an innovative and novel study with rigorous scientific design that will assess and monitor symptomatic relief and improved function following CBD administration (active) or placebo-control using a randomized, double-blind, placebo-controlled, cross-over study design.
The investigators will be recruiting 30 adult men and women, between 40 and 75 years of age, with an established clinical diagnosis of knee OA.
To be included in the study, participants must report having moderate to severe knee pain (≥4/10) with physical activity in one or both knees.
Subjects will be required to complete a 78-day study trial spanning a pre-dosing screening visit, baseline testing, 30-day dosing regimen with follow-up testing.
A 2-week wash-out period will be followed by the cross-over phase using identical baseline and follow-up testing procedures.
The data from the active CBD phase will be compared to data from the placebo-control phase.
There is an extremely large consumer base for CBD-related products in the US, and this base will be expanding exponentially over the course of this decade; therefore, scientific investigation into its therapeutic potential is necessary.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paul A. Borsa, PhD
- Phone Number: 352-294-1726
- Email: pborsa@ufl.edu
Study Contact Backup
- Name: John W Stauffer, MS
- Phone Number: 352-294-1777
- Email: johnstauffer@ufl.edu
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- established clinical diagnosis of knee osteoarthritis (KOA)
- moderate to severe knee pain (≥4/10) with physical activity in one or both knees
Exclusion Criteria:
- pregnant (urine pregnancy test) or lactating
- current cannabis (THC and/or CBD) use (urine drug screen)
- any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject
- 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
- any exposure to another investigational drug within 3 months prior to screening
- BMI ≥ 45
- current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes
history of:
- suicidal ideation or self-harm behavior
- seizure disorder or traumatic brain injury,
- liver or kidney disease, and
- cardiovascular diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Drug
Hemp supplement is a full spectrum CBD-rich formulation (~10%) containing very low levels of THC (<0.3%), along with all naturally occurring minor cannabinoids, terpenes, and essential oils from the plant extract.
|
Administered thrice daily (with food) using a sublingual route of administration
Other Names:
|
Placebo Comparator: Vehicle Control
A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo.
|
Administered thrice daily (with food) using a sublingual route of administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: Weekly until 1 month
|
Categorical scale, None or not at all (0) and very severe or very much (4), higher scores mean worse outcome
|
Weekly until 1 month
|
Theoretical Framework of Acceptability Questionnaire (TFAQ)
Time Frame: Baseline and 1 month
|
Likert scale, 1 and 5, higher scores mean worse outcome
|
Baseline and 1 month
|
Self-report Ratings of Knee Pain
Time Frame: Baseline and 1 month, daily until 1 month
|
Numeric Rating Scale, 0 and 10, higher scores mean worse outcome
|
Baseline and 1 month, daily until 1 month
|
Physical Activity
Time Frame: Daily until 1 month
|
Accelerometer measures step counts per day
|
Daily until 1 month
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Baseline and 1 month
|
Categorical scale, none (0) and extreme (4), higher scores mean worse outcome
|
Baseline and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative Sensory Testing (QST)
Time Frame: Baseline and 1 month
|
A set of noninvasive tests used to assess pain sensitivity
|
Baseline and 1 month
|
Physical Function
Time Frame: Baseline and 1 month
|
Timed Stair-climbing Test (sec)
|
Baseline and 1 month
|
Fear of Pain Questionnaire III (FPQ III)
Time Frame: Baseline and 1 month
|
Likert scale, 0 and 5, higher scores mean worse outcome
|
Baseline and 1 month
|
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline and 1 month
|
Likert scale, 0 and 4, higher scores mean worse outcome
|
Baseline and 1 month
|
Pain Anxiety Symptom Scale (PASS-20)
Time Frame: Baseline and 1 month
|
Likert scale, 0 and 5, higher scores mean worse outcome
|
Baseline and 1 month
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and 1 month
|
Categorical scale, Not during the past month to and Three or more times a week, higher scores mean worse outcome
|
Baseline and 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202301136
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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