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

NCT06435299 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 29BRC23.0164
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pruritus

Keywords

itching; THC; CBD

Outcome Measures

Primary Outcomes (2)

• WI-NRS change

  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.

  Week 0

• WI-NRS change

  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.

  Week 6

Secondary Outcomes (18)

• WI-NRS change from W0 to W2

  Week 0

• WI-NRS change from W0 to W2

  Week 2

• WI-NRS change from W2 to W6

  Week 2

• WI-NRS change from W2 to W6

  Week 6

• ItchyQoL change from W0 to W2

  Week 0

Study Arms (2)

Cannabis oil

EXPERIMENTAL

CBD:THC oil 50mg/mL arm : An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say then only 0.1 per day , up to 1 ml/day maximum. If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks.

Drug: Cannabis oil

PLACEBO

PLACEBO COMPARATOR

Placebo arm : An auto-titration phase will take place during the first 14 days of treatment with the same modalities as experimental group If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks.

Drug: Placebo

Interventions

Cannabis oil DRUG

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)

Cannabis oil

Placebo DRUG

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)

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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)

You may not qualify if:

• 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
• History of hypersensitivity or allergy to any cannabinoid product.
• Allergy to nuts.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (6)

CHU Angers

Angers, France, 49000, France

Location

CHD Vendée

La Roche-sur-Yon, France, 85925, France

Location

Groupe Hospitalier La Rochelle

La Rochelle, France, 17300, France

Location

CHU de Nantes

Nantes, France, 44093, France

Location

CHU de Poitiers

Poitiers, France, 86000, France

Location

CHRU de Tours

Tours, France, 37044, France

Location

MeSH Terms

Conditions

Pruritus

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laurent MISERY, PU-PH

CONTACT

laurent.misery@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: May 30, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (6)