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Not yet recruiting NCT06435299

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

Phase II Interventional Pruritus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabis oil, Placebo.
Who it may be relevant to
Registry conditions: Pruritus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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)
  • Drug 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)

Primary outcome measures

  • WI-NRS change [Time frame: Week 0]
  • WI-NRS change [Time frame: Week 6]
Secondary outcome measures (12)
  • WI-NRS change from W0 to W2 [Time frame: Week 0]
  • WI-NRS change from W0 to W2 [Time frame: Week 2]
  • WI-NRS change from W2 to W6 [Time frame: Week 2]
  • WI-NRS change from W2 to W6 [Time frame: Week 6]
  • ItchyQoL change from W0 to W2 [Time frame: Week 0]
  • ItchyQoL change from W0 to W2 [Time frame: Week 2]
  • ItchyQoL change from W2 to W6 [Time frame: Week 2]
  • ItchyQoL change from W2 to W6 [Time frame: Week 6]
  • Chronic Itch Burden Scale change from W0 to W2 [Time frame: Week 0]
  • Chronic Itch Burden Scale change from W0 to W2 [Time frame: Week 2]
  • Chronic Itch Burden Scale change from W2 to W6 [Time frame: Week 2]
  • Chronic Itch Burden Scale change from W2 to W6 [Time frame: Week 6]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 6 centers
  • 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

Identifiers

NCT: NCT06435299 · 29BRC23.0164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗