Osteoarthritis, KneePhase 1/2SLACK-OANCT06414473
CBD for Knee Osteoarthritis
A Phase 1/2 study testing Cannabidiol (CBD) Extract in people with Osteoarthritis, Knee, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cannabidiol (CBD) Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established clinical diagnosis of knee osteoarthritis (KOA)
- moderate to severe knee pain (≥4/10) with physical activity in one or both knees
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sports Medicine Research Laboratory
Gainesville, Florida, 32601
Paul A Borsa, PhD, 352-294-1726, pborsa@ufl.edu
John W Stauffer, MS, 352-294-1777, john.Stauffer@ufl.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cannabidiol (CBD) Extract, Placebo
- Keywords
- Cannabidiol, Osteoarthritis, Pain, Dysfunction, Physical Activity
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) ExtractDrug
Also called Hemp Supplement
Administered thrice daily (with food) using a sublingual route of administration
PlaceboDrug
Also called Vehicle Control
Administered thrice daily (with food) using a sublingual route of administration
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Active comparator | 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. Receives: Drug: Cannabidiol (CBD) Extract |
| Vehicle Control | Placebo comparator | A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Categorical scale, None or not at all (0) and very severe or very much (4), higher scores mean worse outcome
Measured: Weekly until 1 month
Theoretical Framework of Acceptability Questionnaire (TFAQ)
Likert scale, 1 and 5, higher scores mean worse outcome
Measured: Baseline and 1 month
Self-report Ratings of Knee Pain
Numeric Rating Scale, 0 and 10, higher scores mean worse outcome
Measured: Baseline and 1 month, daily until 1 month
Physical Activity
Accelerometer measures step counts per day
Measured: Daily until 1 month
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Categorical scale, none (0) and extreme (4), higher scores mean worse outcome
Measured: Baseline and 1 month
Secondary outcomes (6)
Quantitative Sensory Testing (QST)
A set of noninvasive tests used to assess pain sensitivity
Measured: Baseline and 1 month
Physical Function
Timed Stair-climbing Test (sec)
Measured: Baseline and 1 month
Fear of Pain Questionnaire III (FPQ III)
Likert scale, 0 and 5, higher scores mean worse outcome
Measured: Baseline and 1 month
Pain Catastrophizing Scale (PCS)
Likert scale, 0 and 4, higher scores mean worse outcome
Measured: Baseline and 1 month
Pain Anxiety Symptom Scale (PASS-20)
Likert scale, 0 and 5, higher scores mean worse outcome
Measured: Baseline and 1 month
Pittsburgh Sleep Quality Index (PSQI)
Categorical scale, Not during the past month to and Three or more times a week, higher scores mean worse outcome
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414473
- Sponsor's protocol ID
- IRB202301136
- Acronym
- SLACK-OA
- Status last verified
- Sep 2025
- First submitted
- 24 Apr 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06414473
- Acronym / sponsor ID
- SLACK-OA / IRB202301136
- Conditions
- Osteoarthritis, Knee
- Keywords
- Cannabidiol, Osteoarthritis, Pain, Dysfunction, Physical Activity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Active comparator | Drug: Cannabidiol (CBD) ExtractHemp 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. |
| Vehicle Control | Placebo comparator | Drug: PlaceboA medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- established clinical diagnosis of knee osteoarthritis (KOA)
- moderate to severe knee pain (≥4/10) with physical activity in one or both knees
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD) ExtractAlso: Hemp SupplementAdministered thrice daily (with food) using a sublingual route of administration | Drug | Active Drug |
| PlaceboAlso: Vehicle ControlAdministered thrice daily (with food) using a sublingual route of administration | Drug | Vehicle Control |
Primary outcome
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
Theoretical Framework of Acceptability Questionnaire (TFAQ)
Time frame: Baseline and 1 month
Likert scale, 1 and 5, higher scores mean worse outcome
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
Physical Activity
Time frame: Daily until 1 month
Accelerometer measures step counts per day
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
6 secondary outcomes
Quantitative Sensory Testing (QST)
Time frame: Baseline and 1 month
Physical Function
Time frame: Baseline and 1 month
Fear of Pain Questionnaire III (FPQ III)
Time frame: Baseline and 1 month
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and 1 month
Pain Anxiety Symptom Scale (PASS-20)
Time frame: Baseline and 1 month
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabidiol (CBD) Extract in people with Osteoarthritis, Knee, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul A. Borsa, PhD (352-294-1726, pborsa@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (time frame: Weekly until 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.