Trial intelligence / Profile preview

THC 25: CBD 25 in Severe Pruritus

NCT06435299Phase 2

Key facts

Status: Not yet recruiting
Start: Jan 2027
Primary completion: Mar 2029
Countries: 1
Sponsor: Centre Hospitalier Universitaire de Brest
Modality: Small Molecules

Drugs: cannabis oil
Conditions: pruritus

Overview

Phase 2, randomised, double-blind trial in pruritus comparing Cannabis oil with PLACEBO (2 arms). Primary endpoint: Worst Itch Numeric Rating Scale at 6 weeks. Planned start Jan 2027; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Cannabis oil
CBD:THC oil 50mg/mL auto-titration then maintenance
PLACEBO
Placebo oil auto-titration then maintenance

Who it enrols

Adults with severe chronic pruritus (WI-NRS >= 7/10) with insufficient relief from accessible therapies. Excludes patients with psychotic disorders, severe hepatic or renal impairment, severe cardiovascular disease, pregnant/breastfeeding women, and recent cannabis users.

Endpoints

Primary

Worst Itch Numeric Rating Scale6 weeks

Secondary

Worst Itch Numeric Rating Scale6 weeks
Itchy Quality of Life6 weeks
Chronic Itch Burden Scale6 weeks
Treatment adverse events8 weeks
Treatment Observance Rate6 weeks

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