Extrait

Background and study aims The purpose of the study is to find out the effect of Cannabidiol (CBD) on brain function. CBD comes from the cannabis plant, but does not produce a 'high' as its effects in humans are almost undetectable except for mild sedation at high doses. We want to learn more about the effect of CBD on the human mind in a simulated version of everyday life. Who can participate? The study is open to people who are currently attending the OASIS clinic, provided that you are not currently taking any psychiatric mediation. Participants can be of either sex, aged between 18 and 50, who are physically well, with no history of major illness. What does the study involve? The study will involve two blocks of 5 days each. On day 1 of each block you will be given a capsule containing either 300 mg CBD or placebo (dummy) in a random order. You will then be given a box containing the remaining doses, and will be asked to take a dose of CBD in the evenings for the next 3 days. On the 5th day of each block you will have the experimental session, where we will start by taking a small blood sample to test how much CBD is in your body. You will then be asked to complete some questionnaires and finally complete the virtual-reality bus ride, followed by a simulated public-speaking task. We will now and then measure your heart rate and take small saliva samples. The CBD week results will be compared with the placebo week results. What are the possible benefits and risks of participating? You will be paid £28 per day you are involved in the study, which is 10 days in total giving a maximum of £280. We will arrange for you to be collected from home by taxi and dropped back home at the end of each day. Some people may experience mild sedation after taking CBD, so we ask you not to drive, operate heavy machinery or engage in hazardous activities during the days you take any capsules. There are no documented effects of CBD on the heart or the nervous system aside from mild sedation, and no adverse effects have been recorded. It can very occasionally happen that some people experience a degree of nausea or disturbances in their vision after being in the virtual reality. Therefore if at any time you wish you stop, we will stop immediately. Where is the study run from? The study is run by the Institute of Psychiatry, Kings College London, UK. When is study starting and how long is it expected to run for? The study started in July 2013 and is expected to run until August 2015. It will be recruiting until January 2015. Who is funding the study? The study is funded by an unrestricted grant from GW Pharma, UK. Who is the main contact? Dr Paul Morrison [email protected]

Critère d'inclusion

• Paranoid cognitions

Liens

• isrctn
• ictrp