Knee OsteoarthritisPhase 2NCT04412837
The Use of Cannabinoid Patch for Knee Osteoarthritis
A Phase 2 study testing Topical CBD Patch in people with Knee Osteoarthritis and CBD, run by Northwell Health at 1 site in United States.
Trial summary
This randomized, double-blind 2-arm parallel group study to determine the efficacy of a cannabinoid (CBD) patch on reducing pain in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, CBD, Osteoarthritis
- What is being tested?
- Topical CBD Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old
- Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4
- Visual analogue scale greater than 3 but less than 9
- Subject is able to provide written informed consent prior to any study procedures or interventions.
- Ability, in the opinion of the investigator, to understand the nature of the study and comply with protocol requirements including compliance with scheduled visits, treatment plan, and any other study procedures outlined in this protocol.
- Able to wear a patch for 24 hours a day
- Able to participate in physical therapy
Who cannot join
- Subject presents with a visual analogue scale score less than 4 or greater than 8.
- Subject is Pregnant.
- Patient has known recent substance abuse or dependence on alcohol (regularly consumes 3 or more alcoholic drinks per day), narcotic analgesics, tranquilizers, or opioids; in the judgement of the investigator within the past 3 years.
- Subject has had prior surgery to the studied lower extremity within 6 months.
- Subject has a known history of allergy to CBD or its derivatives
- Subject has a known history of allergic, idiosyncratic, or serious adverse reactions to acetaminophen.
Show all 12Show fewer
- Patient had recent steroid injection to the studied knee within the last 3 months
- Subject has an inability to be available for follow up
- Any patients with prior liver pathology including, cirrhosis, hepatitis, Hepatic Carcinoma, or elevated liver function tests will be excluded from the study group. Patients with elevated baseline transaminase levels above 3 times the upper limit of normal, accompanied by elevations in bilirubin above 2 times the upper limits of normal.
- Subjects with a medical disorder, condition or history such that could impair the subject's ability to participate or complete this study in the opinion of the investigator.
- Patient has chronic opioid dependency (taking opioid's >3months), currently taking selective serotonin reuptake inhibitor or benzodiazepines.
- Patient currently using CBD product and not willing to discontinue use 1 week prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Orthopedic Institute at Great Neck
New Hyde Park, New York, 11040
About this study
This randomized, double-blind 2-arm parallel group study to determine the efficacy of a cannabinoid (CBD) patch on reducing pain in patients with knee osteoarthritis.
Read the detailed description
The aim of this study is to determine the efficacy of cannabinoid (CBD) patch on reducing pain and improving functional status in patients with knee osteoarthritis (OA). The investigators hypothesize that the use of CBD patch will provide superior pain relief to placebo patch. This will be a randomized, double-blind 2-arm parallel group study in 74 male and female subjects with pain from knee osteoarthritis. Site staff will document the patient's prior treatment for knee osteoarthritis and once the diagnosis has been made, they will be offered to enroll in the study.
After randomization, patients will either be prescribed CBD patch to be used topically for diagnosed knee osteoarthritis versus placebo patch. It will be performed at one site, the physician's office. The study coordinator will be in charge of keeping track of the different patches and all other study personnel and patients will be blinded to the treatment arm. The statistician will conduct the randomization. He will be unblinded and assign participant numbers.
Patients will be diagnosed in an office setting for knee osteoarthritis based on radiographs using the Kellgren Lawrence classification. It is the standard of care to obtain orthogonal knee radiographs when evaluating a patient for knee pain. This will be considered when assessing if the patient is eligible to participate given their pathology. This can be a new diagnosis or an already established diagnosis. The previous treatments that they have received will be noted in the patient charts while screened for eligibility.
Patients taking opioids only recently (less than 3 months) will be required to halt treatment at the time of study enrollment. Opioids don't have anti inflammatory properties so a washout period is not necessary. General patient demographics will be collected using the electronic medical record including: Age, Sex, BMI, Radiographic Osteoarthritis scale (Kellgren Lawrence), which will be put into database by the study investigators and co investigators.
Consent will be obtained by study personnel in the clinical office setting after meeting all study criteria and diagnosis of knee osteoarthritis based on exam and knee xrays. All patients diagnosed with knee osteoarthritis, and who are enrolled in the study, will be prescribed physical therapy that focuses on non-operative treatment such as low impact exercises and activity modification. The patients will not medicate with anti-inflammatory while enrolled in the study. Administration will follow a model of topical patch application which will consist of either the formulated CBD patch (35mg) or identical placebo patch. This patch will be applied to the arthritic knee directly central on the knee. In the event of patients with a diagnosis of bilateral knee OA, the patch will be placed on the knee that has visual analogue scale (VAS) >3 but <9. This patch will be placed daily for 24 hours and replaced each day. Including the initial enrollment visit, the patient will meet with the diagnosing orthopedic surgeon at various time points, and will also have remote check ins by study personnel to assess for adverse events and any issues they are having at 2, 4, and 8 weeks. The patient will have the patch for the first 4 weeks of the study followed by 4 weeks without patch which will conclude their participation at 8 weeks. The patients will all begin physical therapy as part of their routine clinical care within 1 week of beginning the study. During this time the patient will be distributed various surveys to measure patient outcomes. The investigators will be looking at pain as a primary endpoint using visual analogue scale with a 2 point difference deemed the minimal clinically important difference.
Subjects who are randomized to either group who have uncontrolled pain will be instructed to take a rescue medication, acetaminophen over the counter use Q 6 hours as needed will be allowed and recorded in a daily drug use diary which will be provided to them.
The patients will have contact information of the surgeon and residents to contact if any side effects are encountered. Compliance with patch use/application, side effects and adherence to physical therapy will also be recorded. Software with be used for both data collection and survey administration for confidential participation, which is a user-friendly HIPAA compliant service utilized by our health system. If the patient is unable to respond to the surveys via their phone app then hard copies of the survey will be given to them and collected by the investigator.
- Conditions
- Knee Osteoarthritis, CBD, Osteoarthritis
- Being tested
- Topical CBD Patch, Placebo Patch
- Keywords
- Cannabidiol
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical CBD PatchDrug
35 mg CBD patch
Placebo PatchOther
Identical patch without active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| CBD Patch | Experimental | Topical CBD patch to be worn for 24 hours and changed daily for the course of 4 weeks. Receives: Drug: Topical CBD Patch |
| Control Patch | Placebo comparator | Control placebo patch to be worn for 24 hours and changed daily for the course of 4 weeks. Receives: Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of CBD patch on pain for patients with knee osteoarthritis using Visual Analogue Scale.
Efficacy of 35mg CBD Patch vs Placebo Patch on treatment of pain for patients with knee osteoarthritis assessed by a visual analogue scale using 0 as no pain and 10 as the worst pain. This will be collect at weeks 1, 2, 3, 4, and 8, where pain control method (CBD vs Placebo) is the between subjects' effect and week of treatment is the within subjects effect will be used to examine the association between pain control method and that outcome.
Measured: 8 weeks.
Secondary outcomes (5)
Influence of CBD patch on physical and mental health for patients with knee osteoarthritis using the Short Form-12.
The Short Form-12 (SF-12) will be used to asses physical functioning, physical health problems, limitations, emotional problems and global mental health. Two summary scores, a mental component score (MCS-12) and a physical component score (PCS-12), are reported as difference compared to the population average, measured in standard deviations. Each increment of 10 points above or below 50, corresponds to one standard deviation away from the average. Increasing scores correspond to positive physical (maximum 56.6)/mental health (maximum 60.8), decreasing scores correspond to negative physical (minimum 24.0)/mental (minimum 19.1) health.
Measured: 8 weeks.
Influence of CBD patch on quality of sleep for patients with knee osteoarthritis using the Pittsburgh Sleep Quality Index.
The Pittsburgh Sleep Quality Index (measures quality and patterns of sleep) will be given prior to enrollment, and at weeks 1,2,3,4,8. Measures seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme.
Measured: 8 weeks.
Influence of CBD patch on physical function and emotional health for patients with knee osteoarthritis using the Brief Pain Inventory.
Physical function will be measured by the activity sub dimension of the reactive dimension of the Brief Pain Inventory (BPI) (total of the scores for walking, general activity, and work items) Emotional function will be measured by the affective sub dimension of the reactive dimension of the BPI (Total of the scores for relations with others, enjoyment of life, mood, and sleep), on a 0 to 10 scale, where 10 is the negative extreme.
Measured: 8 weeks.
Influence of CBD patch on knee function and pain for patients with knee osteoarthritis using the Knee Injury and Osteoarthritis Outcome Score.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) test will assess pain and function of the knee. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: 8 weeks.
Safety Profile and Adverse Effects of CBD patch
The safety of the CBD patch will be assessed by a 15 item questionnaire of the most commonly reported adverse events of cannabinoids in prior literature. Additional adverse reactions reported by patients or observed by the investigator will be noted and scored.
Scoring of the severity is based on a 0 to 3 interval scale (corresponding to none, mild, moderate, severe), whereby 3 reflects the negative extreme. The patients will be proactively assessed at 2, 4, and 8 weeks.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study startOct 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized double blinded parallel group clinical trial to determine safety and efficacy of 35mg CBD patch vs placebo patch in patients with knee osteoarthritis.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Solace Brands, Inc.
- Responsible party
- Sponsor
- Investigators
- Vijay Rasquinha, MD, Principal investigator, Northwell HealthRobert Duarte, MD, Study director, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412837
- Sponsor's protocol ID
- 20-0048
- Status last verified
- Jan 2023
- First submitted
- 21 May 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.
PubMed 16086839Martin-Santos R, Crippa JA, Batalla A, Bhattacharyya S, Atakan Z, Borgwardt S, Allen P, Seal M, Langohr K, Farre M, Zuardi AW, McGuire PK. Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers. Curr Pharm Des. 2012;18(32):4966-79. doi: 10.2174/138161212802884780.
PubMed 22716148Haney M, Malcolm RJ, Babalonis S, Nuzzo PA, Cooper ZD, Bedi G, Gray KM, McRae-Clark A, Lofwall MR, Sparenborg S, Walsh SL. Oral Cannabidiol does not Alter the Subjective, Reinforcing or Cardiovascular Effects of Smoked Cannabis. Neuropsychopharmacology. 2016 Jul;41(8):1974-82. doi: 10.1038/npp.2015.367. Epub 2015 Dec 28.
PubMed 26708108Babalonis S, Haney M, Malcolm RJ, Lofwall MR, Votaw VR, Sparenborg S, Walsh SL. Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers. Drug Alcohol Depend. 2017 Mar 1;172:9-13. doi: 10.1016/j.drugalcdep.2016.11.030. Epub 2016 Dec 14.
PubMed 28088032Philpott HT, O'Brien M, McDougall JJ. Attenuation of early phase inflammation by cannabidiol prevents pain and nerve damage in rat osteoarthritis. Pain. 2017 Dec;158(12):2442-2451. doi: 10.1097/j.pain.0000000000001052.
PubMed 28885454Malfait AM, Gallily R, Sumariwalla PF, Malik AS, Andreakos E, Mechoulam R, Feldmann M. The nonpsychoactive cannabis constituent cannabidiol is an oral anti-arthritic therapeutic in murine collagen-induced arthritis. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9561-6. doi: 10.1073/pnas.160105897.
PubMed 10920191Hammell DC, Zhang LP, Ma F, Abshire SM, McIlwrath SL, Stinchcomb AL, Westlund KN. Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis. Eur J Pain. 2016 Jul;20(6):936-48. doi: 10.1002/ejp.818. Epub 2015 Oct 30.
PubMed 26517407Xiong W, Cui T, Cheng K, Yang F, Chen SR, Willenbring D, Guan Y, Pan HL, Ren K, Xu Y, Zhang L. Cannabinoids suppress inflammatory and neuropathic pain by targeting alpha3 glycine receptors. J Exp Med. 2012 Jun 4;209(6):1121-34. doi: 10.1084/jem.20120242. Epub 2012 May 14.
PubMed 22585736Lodzki M, Godin B, Rakou L, Mechoulam R, Gallily R, Touitou E. Cannabidiol-transdermal delivery and anti-inflammatory effect in a murine model. J Control Release. 2003 Dec 12;93(3):377-87. doi: 10.1016/j.jconrel.2003.09.001.
PubMed 14644587
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cannabinoid Patch for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04412837
- Acronym / sponsor ID
- 20-0048
- Conditions
- Knee Osteoarthritis, CBD, Osteoarthritis
- Keywords
- Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Solace Brands, Inc.
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 2 Jun 2020 (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.
This randomized, double-blind 2-arm parallel group study to determine the efficacy of a cannabinoid (CBD) patch on reducing pain in patients with knee osteoarthritis.
Detailed description
The aim of this study is to determine the efficacy of cannabinoid (CBD) patch on reducing pain and improving functional status in patients with knee osteoarthritis (OA). The investigators hypothesize that the use of CBD patch will provide superior pain relief to placebo patch. This will be a randomized, double-blind 2-arm parallel group study in 74 male and female subjects with pain from knee osteoarthritis. Site staff will document the patient's prior treatment for knee osteoarthritis and once the diagnosis has been made, they will be offered to enroll in the study.
After randomization, patients will either be prescribed CBD patch to be used topically for diagnosed knee osteoarthritis versus placebo patch. It will be performed at one site, the physician's office. The study coordinator will be in charge of keeping track of the different patches and all other study personnel and patients will be blinded to the treatment arm. The statistician will conduct the randomization. He will be unblinded and assign participant numbers.
Patients will be diagnosed in an office setting for knee osteoarthritis based on radiographs using the Kellgren Lawrence classification. It is the standard of care to obtain orthogonal knee radiographs when evaluating a patient for knee pain. This will be considered when assessing if the patient is eligible to participate given their pathology. This can be a new diagnosis or an already established diagnosis. The previous treatments that they have received will be noted in the patient charts while screened for eligibility.
Patients taking opioids only recently (less than 3 months) will be required to halt treatment at the time of study enrollment. Opioids don't have anti inflammatory properties so a washout period is not necessary. General patient demographics will be collected using the electronic medical record including: Age, Sex, BMI, Radiographic Osteoarthritis scale (Kellgren Lawrence), which will be put into database by the study investigators and co investigators.
Consent will be obtained by study personnel in the clinical office setting after meeting all study criteria and diagnosis of knee osteoarthritis based on exam and knee xrays. All patients diagnosed with knee osteoarthritis, and who are enrolled in the study, will be prescribed physical therapy that focuses on non-operative treatment such as low impact exercises and activity modification. The patients will not medicate with anti-inflammatory while enrolled in the study. Administration will follow a model of topical patch application which will consist of either the formulated CBD patch (35mg) or identical placebo patch. This patch will be applied to the arthritic knee directly central on the knee. In the event of patients with a diagnosis of bilateral knee OA, the patch will be placed on the knee that has visual analogue scale (VAS) >3 but <9. This patch will be placed daily for 24 hours and replaced each day. Including the initial enrollment visit, the patient will meet with the diagnosing orthopedic surgeon at various time points, and will also have remote check ins by study personnel to assess for adverse events and any issues they are having at 2, 4, and 8 weeks. The patient will have the patch for the first 4 weeks of the study followed by 4 weeks without patch which will conclude their participation at 8 weeks. The patients will all begin physical therapy as part of their routine clinical care within 1 week of beginning the study. During this time the patient will be distributed various surveys to measure patient outcomes. The investigators will be looking at pain as a primary endpoint using visual analogue scale with a 2 point difference deemed the minimal clinically important difference.
Subjects who are randomized to either group who have uncontrolled pain will be instructed to take a rescue medication, acetaminophen over the counter use Q 6 hours as needed will be allowed and recorded in a daily drug use diary which will be provided to them.
The patients will have contact information of the surgeon and residents to contact if any side effects are encountered. Compliance with patch use/application, side effects and adherence to physical therapy will also be recorded. Software with be used for both data collection and survey administration for confidential participation, which is a user-friendly HIPAA compliant service utilized by our health system. If the patient is unable to respond to the surveys via their phone app then hard copies of the survey will be given to them and collected by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This will be a randomized double blinded parallel group clinical trial to determine safety and efficacy of 35mg CBD patch vs placebo patch in patients with knee osteoarthritis.
| Arm | Type | Receives |
|---|---|---|
| CBD Patch | Experimental | Drug: Topical CBD PatchTopical CBD patch to be worn for 24 hours and changed daily for the course of 4 weeks. |
| Control Patch | Placebo comparator | Other: Placebo PatchControl placebo patch to be worn for 24 hours and changed daily for the course of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age>18 years old
- Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4
- Visual analogue scale greater than 3 but less than 9
- Subject is able to provide written informed consent prior to any study procedures or interventions.
- Ability, in the opinion of the investigator, to understand the nature of the study and comply with protocol requirements including compliance with scheduled visits, treatment plan, and any other study procedures outlined in this protocol.
Key exclusion criteria (12 listed)
- Subject presents with a visual analogue scale score less than 4 or greater than 8.
- Subject is Pregnant.
- Patient has known recent substance abuse or dependence on alcohol (regularly consumes 3 or more alcoholic drinks per day), narcotic analgesics, tranquilizers, or opioids; in the judgement of the investigator within the past 3 years.
- Subject has had prior surgery to the studied lower extremity within 6 months.
- Subject has a known history of allergy to CBD or its derivatives
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 |
|---|---|---|
| Topical CBD Patch35 mg CBD patch | Drug | CBD Patch |
| Placebo PatchIdentical patch without active ingredient. | Other | Control Patch |
Primary outcome
Influence of CBD patch on pain for patients with knee osteoarthritis using Visual Analogue Scale.
Time frame: 8 weeks.
Efficacy of 35mg CBD Patch vs Placebo Patch on treatment of pain for patients with knee osteoarthritis assessed by a visual analogue scale using 0 as no pain and 10 as the worst pain. This will be collect at weeks 1, 2, 3, 4, and 8, where pain control method (CBD vs Placebo) is the between subjects' effect and week of treatment is the within subjects effect will be used to examine the association between pain control method and that outcome.
5 secondary outcomes
Influence of CBD patch on physical and mental health for patients with knee osteoarthritis using the Short Form-12.
Time frame: 8 weeks.
Influence of CBD patch on quality of sleep for patients with knee osteoarthritis using the Pittsburgh Sleep Quality Index.
Time frame: 8 weeks.
Influence of CBD patch on physical function and emotional health for patients with knee osteoarthritis using the Brief Pain Inventory.
Time frame: 8 weeks.
Influence of CBD patch on knee function and pain for patients with knee osteoarthritis using the Knee Injury and Osteoarthritis Outcome Score.
Time frame: 8 weeks.
Safety Profile and Adverse Effects of CBD patch
Time frame: 8 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 16086839Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.
- Background: PubMed 22716148Martin-Santos R, Crippa JA, Batalla A, Bhattacharyya S, Atakan Z, Borgwardt S, Allen P, Seal M, Langohr K, Farre M, Zuardi AW, McGuire PK. Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers. Curr Pharm Des. 2012;18(32):4966-79. doi: 10.2174/138161212802884780.
- Background: PubMed 26708108Haney M, Malcolm RJ, Babalonis S, Nuzzo PA, Cooper ZD, Bedi G, Gray KM, McRae-Clark A, Lofwall MR, Sparenborg S, Walsh SL. Oral Cannabidiol does not Alter the Subjective, Reinforcing or Cardiovascular Effects of Smoked Cannabis. Neuropsychopharmacology. 2016 Jul;41(8):1974-82. doi: 10.1038/npp.2015.367. Epub 2015 Dec 28.
- Background: PubMed 28088032Babalonis S, Haney M, Malcolm RJ, Lofwall MR, Votaw VR, Sparenborg S, Walsh SL. Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers. Drug Alcohol Depend. 2017 Mar 1;172:9-13. doi: 10.1016/j.drugalcdep.2016.11.030. Epub 2016 Dec 14.
- Background: PubMed 28885454Philpott HT, O'Brien M, McDougall JJ. Attenuation of early phase inflammation by cannabidiol prevents pain and nerve damage in rat osteoarthritis. Pain. 2017 Dec;158(12):2442-2451. doi: 10.1097/j.pain.0000000000001052.
- Background: PubMed 10920191Malfait AM, Gallily R, Sumariwalla PF, Malik AS, Andreakos E, Mechoulam R, Feldmann M. The nonpsychoactive cannabis constituent cannabidiol is an oral anti-arthritic therapeutic in murine collagen-induced arthritis. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9561-6. doi: 10.1073/pnas.160105897.
- Background: PubMed 26517407Hammell DC, Zhang LP, Ma F, Abshire SM, McIlwrath SL, Stinchcomb AL, Westlund KN. Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis. Eur J Pain. 2016 Jul;20(6):936-48. doi: 10.1002/ejp.818. Epub 2015 Oct 30.
- Background: PubMed 22585736Xiong W, Cui T, Cheng K, Yang F, Chen SR, Willenbring D, Guan Y, Pan HL, Ren K, Xu Y, Zhang L. Cannabinoids suppress inflammatory and neuropathic pain by targeting alpha3 glycine receptors. J Exp Med. 2012 Jun 4;209(6):1121-34. doi: 10.1084/jem.20120242. Epub 2012 May 14.
- Background: PubMed 14644587Lodzki M, Godin B, Rakou L, Mechoulam R, Gallily R, Touitou E. Cannabidiol-transdermal delivery and anti-inflammatory effect in a murine model. J Control Release. 2003 Dec 12;93(3):377-87. doi: 10.1016/j.jconrel.2003.09.001.
- Topical treatments for osteoarthritis of the knee - Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews - NCBI BookshelfLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vijay Rasquinha, MD principal investigator
Northwell Health
Robert Duarte, MD study director
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical CBD Patch in people with Knee Osteoarthritis and CBD, run by Northwell Health 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 7 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: withdrawn, as of the sponsor's last update on 19 Jan 2023. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of CBD patch on pain for patients with knee osteoarthritis using Visual Analogue Scale. (time frame: 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04412837, which also lists 9 linked publications.
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 19 Jan 2023.