Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-27
Brief Title:
Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus a Multicenter Double-blind Randomized Placebo-controlled Study
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus a Multicenter Double-blind Randomized Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANNABITCH
Brief Summary:
Pruritus is defined as an unpleasant sensation leading to the need to scratch Medications for pruritus are much less effective than those used for pain and it is imperative to find new therapeutic options
Over the last 20 years the understanding of the pathophysiology of pruritus has progressed significantly opening new possible therapeutic fields Among these cannabinoids seem very promising because the physiological inhibitory role of endocannabinoids mainly produced by neurons has been well demonstrated Data from the literature suggest that the antipruritic effects of cannabinoids are due to a combination of effects on neuronal activation transmission along the afferent pathway and local modulation of keratinocytes and mast cells The antipruritic effect is peripheral and central through modulation of CB1 CB2 or TRPV1 channels CB1 and CB2 receptors are specific cannabinoid receptors CB1 being present at the central and peripheral level while CB2 is only peripheral and very present in the skin Cannabinoids can also bind to TRPV1 and thus inhibit neurogenic inflammation by antagonizing or stabilizing this ion channel which prevents neuronal activation by pruritogenic mediators Phytocannabinoids are derived from cannabis and are used for a variety of purposes with their development for medical purposes expanding rapidly The two best known are tetrahydrocannabinol THC and cannabidiol CBD THC binds to TRPV1 CB2 and CB1 the activation of the latter being at the origin of parallel psychotropic effects CBD binds mainly to TRPV1 which allows us to expect very favorable effects on pruritus neurogenic inflammation and skin pain without fearing side effects of this type
A limited number of studies suggest that cannabinoids may be useful topically or systemically in humans or animals but no comparative study with placebo has been performed These encouraging results have been observed in cases of induced pruritus idiopathic pruritus eczema uremic pruritus cholestatic pruritus prurigo sensitive skin or even epidermolysis bullosa
Currently the ANSM is conducting an evaluation of the effects of medical cannabis on severe pain We propose to evaluate the effects on severe pruritus in a randomized placebo-controlled study one of the products chosen by the ANSM in this context the oil LITTLE GREEN PHARMA which we choose for its dominant CBD ratio THC 5 mgml CBD 5 mgml
Over the last 20 years the understanding of the pathophysiology of pruritus has progressed significantly opening new possible therapeutic fields Among these cannabinoids seem very promising because the physiological inhibitory role of endocannabinoids mainly produced by neurons has been well demonstrated Data from the literature suggest that the antipruritic effects of cannabinoids are due to a combination of effects on neuronal activation transmission along the afferent pathway and local modulation of keratinocytes and mast cells The antipruritic effect is peripheral and central through modulation of CB1 CB2 or TRPV1 channels CB1 and CB2 receptors are specific cannabinoid receptors CB1 being present at the central and peripheral level while CB2 is only peripheral and very present in the skin Cannabinoids can also bind to TRPV1 and thus inhibit neurogenic inflammation by antagonizing or stabilizing this ion channel which prevents neuronal activation by pruritogenic mediators Phytocannabinoids are derived from cannabis and are used for a variety of purposes with their development for medical purposes expanding rapidly The two best known are tetrahydrocannabinol THC and cannabidiol CBD THC binds to TRPV1 CB2 and CB1 the activation of the latter being at the origin of parallel psychotropic effects CBD binds mainly to TRPV1 which allows us to expect very favorable effects on pruritus neurogenic inflammation and skin pain without fearing side effects of this type
A limited number of studies suggest that cannabinoids may be useful topically or systemically in humans or animals but no comparative study with placebo has been performed These encouraging results have been observed in cases of induced pruritus idiopathic pruritus eczema uremic pruritus cholestatic pruritus prurigo sensitive skin or even epidermolysis bullosa
Currently the ANSM is conducting an evaluation of the effects of medical cannabis on severe pain We propose to evaluate the effects on severe pruritus in a randomized placebo-controlled study one of the products chosen by the ANSM in this context the oil LITTLE GREEN PHARMA which we choose for its dominant CBD ratio THC 5 mgml CBD 5 mgml
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None