Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588972
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-12
Brief Title:
Analgesic Effects of a Treatment with Cannabis Sativa Extract in Patients with Knee Osteoarthritis - CANOA Cannabis for Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analgesic Effects of a Treatment with Cannabis Sativa Extract in Patients with Knee Osteoarthritis - CANOA Cannabis for Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoarthritis OA is the most prevalent joint disease in humans often causing disability in affected individuals especially the elderly OA is featured by mechanical articular pain crackling and short post-immobilization stiffness OA pain has variable pathophysiology and despite many pharmacological options available its treatment is often ineffective and presents significant side effects On this way the search for more effective and safer treatments is paramount on the OA field Among potential treatments are the Cannabis-derived substances Cannabis plants have been used for diverse purposes by mankind over thousands of years Its best-known species Cannabis sativa has more than a hundred substances called cannabinoids or more specifically phytocannabinoids the most important of which are tetrahydrocannabinol THC and cannabidiol CBD These two phytocannabinoids display a number of pharmacological effects when used together or in isolation Although many preclinical studies indicate usefulness of phytocannabinoids currently the clinical evidence for its application is still scarce Thus this project aims to investigate the effects of an extract of Cannabis sativa rich in THC and CBD on pain of patients with knee OA as well as the possible adverse events of this treatment
Detailed Description:
Osteoarthritis OA is the most common osteoarticular pathology in humans In Brazil in 2004 its prevalence was estimated at 414 of the population and is likely even higher today given the countrys accelerated aging and the increasing prevalence of obesity
The pain of OA has variable pathophysiology with nociceptive inflammatory and neuropathic mechanisms along with central and peripheral sensitization being the main cause of functional disability in patients
Currently the pharmacological therapeutic arsenal for treating OA pain includes non-steroidal anti-inflammatory drugs NSAIDs opioids and intra-articular corticosteroids However their use is associated with undesirable adverse effects more common in the geriatric population which is already exposed to polypharmacy Due to the heterogeneity of pain pathophysiology in OA no medication is fully effective in its control and combinations of different classes of drugs with diverse mechanisms of action are generally employed along with non-pharmacological measures such as patient education rehabilitation and when necessary surgical interventions
Several studies demonstrate that cannabis has antiemetic appetite-stimulating analgesic euphoric anti-inflammatory anticonvulsant and sedative effects Pain is the main cause of functional disability in patients affected by OA Modulation of the endocannabinoid system through CB1 and CB2 receptor agonists as well as FAAH inhibitors has shown antinociceptive effects in animal models of OA induced by monosodium iodoacetate MIA collagen and adjuvants as well as in models of natural OA in guinea pigs
Other preclinical studies have shown potential effects of cannabinoids on OA progression such as the inhibition of enzymes that produce local inflammatory mediators such as nitric oxide and prostaglandin E2 matrix metalloproteinases and modulation of cortisol-mediated synovial fibroblast adhesion
This will be a double-blind randomized placebo-controlled clinical trial Patients who meet the inclusion criteria and agree to participate in the study will be randomized in a 11 ratio to three experimental groups each with a sample size of 16 individuals treated for 60 days as follows
Group 1 placebo Medium Chain Triglycerides solution without any active principle Group 2 C sativa extract with a THCCBD ratio of 110 2mg20mgday Group 3 C sativa extract with a THCCBD ratio of 110 4mg40mgday All patients selected for this study if using any pharmacological or non-pharmacological therapy for OA will have these therapies maintained throughout the clinical trial
The experimental product acquired by LCP consists of a full spectrum extract of Cannabis sativa with a concentration of 20 mgmL CBD and 2 mgmL THC diluted in the vehicle MCT medium-chain triglycerides All clinical evaluations will be conducted at three time points T0 T30 and T60 while laboratory evaluations will be analyzed at T0 and T60
Aim To evaluate the analgesic effect of a treatment with THCCBD doses of a C sativa extract in patients diagnosed with osteoarthritis
Objectives
To evaluate the analgesic effect of a THCCBD treatment in C sativa extract in patients diagnosed with osteoarthritis To evaluate the anti-inflammatory effect of a THCCBD treatment in C sativa extract in patients diagnosed with osteoarthritis To evaluate the symptomatic clinical safety profile of the treatment To evaluate the renal hepatic and hemostatic safety profile of the treatment To determine if there is an association between Lipoxin A4 levels and pain intensity levels in patients diagnosed with osteoarthritis
Hypothesis
The prescribed doses of THCCBDday induce analgesic and anti-inflammatory effects in patients diagnosed with osteoarthritis
The pain of OA has variable pathophysiology with nociceptive inflammatory and neuropathic mechanisms along with central and peripheral sensitization being the main cause of functional disability in patients
Currently the pharmacological therapeutic arsenal for treating OA pain includes non-steroidal anti-inflammatory drugs NSAIDs opioids and intra-articular corticosteroids However their use is associated with undesirable adverse effects more common in the geriatric population which is already exposed to polypharmacy Due to the heterogeneity of pain pathophysiology in OA no medication is fully effective in its control and combinations of different classes of drugs with diverse mechanisms of action are generally employed along with non-pharmacological measures such as patient education rehabilitation and when necessary surgical interventions
Several studies demonstrate that cannabis has antiemetic appetite-stimulating analgesic euphoric anti-inflammatory anticonvulsant and sedative effects Pain is the main cause of functional disability in patients affected by OA Modulation of the endocannabinoid system through CB1 and CB2 receptor agonists as well as FAAH inhibitors has shown antinociceptive effects in animal models of OA induced by monosodium iodoacetate MIA collagen and adjuvants as well as in models of natural OA in guinea pigs
Other preclinical studies have shown potential effects of cannabinoids on OA progression such as the inhibition of enzymes that produce local inflammatory mediators such as nitric oxide and prostaglandin E2 matrix metalloproteinases and modulation of cortisol-mediated synovial fibroblast adhesion
This will be a double-blind randomized placebo-controlled clinical trial Patients who meet the inclusion criteria and agree to participate in the study will be randomized in a 11 ratio to three experimental groups each with a sample size of 16 individuals treated for 60 days as follows
Group 1 placebo Medium Chain Triglycerides solution without any active principle Group 2 C sativa extract with a THCCBD ratio of 110 2mg20mgday Group 3 C sativa extract with a THCCBD ratio of 110 4mg40mgday All patients selected for this study if using any pharmacological or non-pharmacological therapy for OA will have these therapies maintained throughout the clinical trial
The experimental product acquired by LCP consists of a full spectrum extract of Cannabis sativa with a concentration of 20 mgmL CBD and 2 mgmL THC diluted in the vehicle MCT medium-chain triglycerides All clinical evaluations will be conducted at three time points T0 T30 and T60 while laboratory evaluations will be analyzed at T0 and T60
Aim To evaluate the analgesic effect of a treatment with THCCBD doses of a C sativa extract in patients diagnosed with osteoarthritis
Objectives
To evaluate the analgesic effect of a THCCBD treatment in C sativa extract in patients diagnosed with osteoarthritis To evaluate the anti-inflammatory effect of a THCCBD treatment in C sativa extract in patients diagnosed with osteoarthritis To evaluate the symptomatic clinical safety profile of the treatment To evaluate the renal hepatic and hemostatic safety profile of the treatment To determine if there is an association between Lipoxin A4 levels and pain intensity levels in patients diagnosed with osteoarthritis
Hypothesis
The prescribed doses of THCCBDday induce analgesic and anti-inflammatory effects in patients diagnosed with osteoarthritis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None