Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.
Recent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.
Preclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.
Therefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.
Age ≥ 18 years
Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
Stable treatment (for treatment of the prurit) for at least 6 weeks
Patients unable to consent.
Patients refusing to participate in research.
Patients under guardianship or conservatorship.
Personal history of psychotic disorders.
Parallel
Cannabis oil
DrugPatients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
Placebo
DrugPatients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
WI-NRS change
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
WI-NRS change
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
WI-NRS change from W0 to W2
\- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2
WI-NRS change from W0 to W2
\- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2
WI-NRS change from W2 to W6
Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.
WI-NRS change from W2 to W6
Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.
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