CBD - Sleep and Waking Perfomance

• Research type

  Research Study

• Full title

  A randomized, double-blind, three-way crossover study to assess the effects of GWP42003-P (Cannabidiol; CBD) on sleep and waking performance in healthy adults

• IRAS ID

  172310

• Contact name

  Veronika Horvathova

• Sponsor organisation

  GW Pharmaceuticals

• Eudract number

  2014-005570-11

• Duration of Study in the UK

  0 years, 7 months, 31 days

• Research summary

  The aim of the study is to assess the quality and duration of sleep, and level of alertness and ability to perform certain tasks in the evening before bed and in the morning after waking following an evening dose of either GWP42003-P (study drug), at two different doses (750 and 1500 mg), or placebo (dummy drug).

  The active ingredient in the study drug GWP42003-P is made from extracts of the cannabis plant. There are two main active compounds in cannabis: 9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is responsible for the psychoactive effects of cannabis (the “high”) whereas CBD lacks psychoactivity and appears to have potentially beneficial physiological effects including anticonvulsant, antipsychotic, antioxidant and anti-inflammatory activity. GWP42003-P contains >99% CBD and <0.1% THC.

  CBD has been administered to epilepsy patients due to its anticonvulsant properties and it has been noted that the most common side effect of the drug is sleepiness. The current study will investigate whether CBD has sleep-inducing properties at the doses that are used to treat epilepsy. This property could be beneficial to patients with different forms of epilepsy whose night time sleep is interrupted by seizures.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  15/LO/0595

• Date of REC Opinion

  1 Jun 2015

• REC opinion

  Further Information Favourable Opinion