Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study

Обзор

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.

Вмешательства

• Препарат Cannabis oil
  Patients 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)
• Препарат Placebo
  Patients 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)

Первичные конечные точки

• WI-NRS change [Срок оценки: Week 0]
• WI-NRS change [Срок оценки: Week 6]

Вторичные конечные точки (12)

• WI-NRS change from W0 to W2 [Срок оценки: Week 0]
• WI-NRS change from W0 to W2 [Срок оценки: Week 2]
• WI-NRS change from W2 to W6 [Срок оценки: Week 2]
• WI-NRS change from W2 to W6 [Срок оценки: Week 6]
• ItchyQoL change from W0 to W2 [Срок оценки: Week 0]
• ItchyQoL change from W0 to W2 [Срок оценки: Week 2]
• ItchyQoL change from W2 to W6 [Срок оценки: Week 2]
• ItchyQoL change from W2 to W6 [Срок оценки: Week 6]
• Chronic Itch Burden Scale change from W0 to W2 [Срок оценки: Week 0]
• Chronic Itch Burden Scale change from W0 to W2 [Срок оценки: Week 2]
• Chronic Itch Burden Scale change from W2 to W6 [Срок оценки: Week 2]
• Chronic Itch Burden Scale change from W2 to W6 [Срок оценки: Week 6]

Критерии участия

Критерии включения

• 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
• Affiliated or benefiting of a social security
• Informed consent (personally dated and) signed by the participant or any representatives (impartial witness/trusted person)

Критерии исключения

• Patients unable to consent.
• Patients refusing to participate in research.
• Patients under guardianship or conservatorship.
• Personal history of psychotic disorders.
• Severe hepatic impairment, defined as prothrombin level <50% or with predictive biological impairment.
• Moderate to severe renal impairment, with an estimated glomerular filtration rate ≤ 44 mL/min/1.73 m².
• Severe cardiovascular or cerebrovascular disease, including history of myocardial infarction or stroke.
• Pregnant or breastfeeding women.
• Lack of understanding of questionnaires or inability to follow up.
• Women of childbearing potential unwilling to use appropriate contraception.
• Cannabinoid use outside the clinical trial
• Use of cannabis or its derivatives less than one week before inclusion
• History of hypersensitivity or allergy to any cannabinoid product.
• Allergy to nuts.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• CHU Angers — Angers
• CHD Vendée — La Roche-sur-Yon
• Groupe Hospitalier La Rochelle — La Rochelle
• CHU de Nantes — Nantes
• CHU de Poitiers — Poitiers
• CHRU de Tours — Tours

Идентификаторы

NCT: NCT06435299 · 29BRC23.0164

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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