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

ClinConnect Summary

This clinical trial is investigating the effects of a compound called cannabidiol (CBD) in patients suffering from severe itching, known as pruritus. The goal is to see if CBD can help relieve this uncomfortable sensation, which can be much harder to treat than pain. The study will involve comparing CBD oil to a placebo (a substance with no active ingredients) to determine how effective it is in reducing pruritus. Researchers hope that CBD will provide relief without the side effects often associated with other treatments.

To participate in this trial, individuals must be at least 18 years old and have severe itching that hasn't responded well to other treatments. They should have a consistent treatment plan in place for at least six weeks before joining the study. Participants will be monitored for their response to the treatment and any side effects they may experience. It's important to note that certain individuals, such as those with specific health conditions or who are pregnant or breastfeeding, may not be eligible to join. This study is currently not recruiting participants, but it aims to provide valuable information about a new potential treatment for severe itching.

Gender

ALL

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.