Experimental Medicine in ADHD: effects of cannabinoids (EMA-C)
Research type
Research Study
Full title
The effects of sativex on neurocognitive and behavioral function in adults with attention-deficit/hyperactivity disorder; the EMA-C study (experimental medicine in ADHD - cannabinoids)
IRAS ID
143364
Contact name
Philip Asherson
Contact email
Sponsor organisation
King's College London
Research summary
The main aim of this study is to provide preliminary data on the relationship of pharmacological modulation of the endocannabinoid system (ECS) on neurocognitive measures of brain and behavioural function in adults with attention-deficit/hyperactivity disorder (ADHD). Abnormal dopamine transmission in the striatum is thought to play a pivotal role in ADHD, and dopamine signalling in the striatum is modulated by the ECS.
The study aims will be achieved by investigating the potential effects of Sativex oromucosal spray, a cannabinoid-based medication (GW Pharma Ltd, UK) on neurocognitive and behavioural measures in adult ADHD cases. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. The study design will be a 6-week double blind placebo controlled study, with a group of 30 adults meeting research diagnostic criteria for ADHD. The group will be divided into 15 participants who receive Sativex and 15 who receive placebo, medication titration will occur in the first 2 weeks with assessments at baseline (day 1), day 14 and day 42. Allocation to Sativex treatment and placebo groups will be random and blind to both the investigator and participants. The study will be exploratory, focusing on neurocognitive changes and their relationship to behavioral symptoms. The overall aim is to investigate the changes in brain function and their relationship to behavioral symptoms, allowing an initial investigation of the relationship of the ECS to the neurocognitive and behavioral dysfunctions seen in ADHD
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0606
Date of REC Opinion
11 Jun 2014
REC opinion
Further Information Favourable Opinion