Efficacy and Tolerance of Cannabidiol in Patients with Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study

Launched by UNIVERSITY HOSPITAL, BREST · May 29, 2024

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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.