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

NCT06435299 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Brest

Phase

Phase 2

Started

2027-01-01

Last updated

2026-06-12

Condition(s) studied

Pruritus

Investigational drug(s) / intervention(s)

Cannabis oil →Placebo

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)

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)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

WI-NRS change — Week 0
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 — Week 6
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.

Trial sites (6)

Facility	City	Region
CHU Angers	Angers	France
CHD Vendée	La Roche-sur-Yon	France
Groupe Hospitalier La Rochelle	La Rochelle	France
CHU de Nantes	Nantes	France
CHU de Poitiers	Poitiers	France
CHRU de Tours	Tours	France

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Other trials for the same condition

Establishment of a Patient Library in Patients With Pruritus Sine Materia Recruiting

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06435299 on ClinicalTrials.gov ↗ ← All trials in France