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

Study acronym: CANNA-ITCH
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Phase 3 to Phase 2v6 Show 4 more changesShow less
    • Primary and study completion dates: Jul 1, 2027 to Mar 1, 2029
    • Start date: May 1, 2025 to Jan 1, 2027
    • Study sites: 7 to 6
    • Study title expanded, about 3 words
  2. Primary completion date: Feb 14, 2026 to Jul 1, 2027
    • Start date: Jan 1, 2025 to May 1, 2025
    • Study completion date: Nov 28, 2026 to Jul 1, 2027
    v5
  3. Study sites: 0 to 7
    • Eligibility criteria shortened, about 23 words
    • Secondary endpoints: 31 to 18
    v4
  4. Primary completion date: Nov 14, 2024 to Feb 14, 2026
    • Start date: Oct 1, 2024 to Jan 1, 2025
    • Study completion date: Nov 28, 2024 to Nov 28, 2026
    v3
  5. Start date: Jul 1, 2024 to Oct 1, 2024
    • Primary completion date: Sep 14, 2024 to Nov 14, 2024
    • Study completion date: Sep 28, 2024 to Nov 28, 2024
    • Eligibility criteria expanded, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06435299
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Pruritus
Related terms Pruritus
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov