Tetra-hydro-cannabinol, cannabidiol and their combination for the treatment of peripheral neuropathic pain. A randomised placebo-controlled trial. - THC, CBD and their combination for treatment of peripheral neuropathic pain

Odense University Hospital0 个研究点目标入组 150 人开始时间: 2018年1月4日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•- age = 18 years
•- definite or probable peripheral neuropathic pain (IASP criteria) due to polyneuropathy, postherpetic neuralgia or nerve injury
•- Diabetic polyneuropathy: definite or probable (criteria: Tesfaye et al. 2010)
•- Non-diabetic polyneuropathy: abnormal sensibility and abnormal nerve conduction, intra-epidermal nerve fiber density, or quantitative sensory examination
•- duration of pain more than 6 months
•- mean of average daily pain (0-10 numeric rating scale) during 1 week more than or equal to 4 and less than 10 and pain present every day
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•- known allergy or important side effects to study drugs
•- pregnancy or breast feeding
•- severe heart, kidney or liver disease
•- schizophrenia, current depression, previous severe depression, previous suicidal behavior, or other important psychiatric diseases
•- first degree relatives with schizophrenia
•- treatment with strong opioids or tramadol that cannot be stopped
•- heavy use of sedatives/hypnotics
•- current or previous drug abuse
•- current or recent alcohol abuse

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