Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 218
- 试验地点
- 13
- 主要终点
- WI-NRS change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Cannabis oil
Cannabis 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 1.4 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.
干预措施: Cannabis oil (Drug)
PLACEBO
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.
干预措施: Placebo (Drug)
结局指标
主要结局
WI-NRS change
时间窗: 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.
次要结局
- Treatment Observance Rate(Week 6)
- WI-NRS change from W2 to W6(Week 6)
- WI-NRS change from W0 to W2(Week 2)
- ItchyQoL change from W0 to W2(Week 2)
- ItchyQoL change from W2 to W6(Week 6)
- Chronic Itch Burden Scale change from W0 to W2(Week 2)
- Chronic Itch Burden Scale change from W2 to W6(Week 6)
- Treatment adverse events(Week 8)