Cannabidiol: a novel intervention for cannabis use problems?
Research type
Research Study
Full title
A phase IIa/b, randomised, double-blind, placebo-controlled, single-site, parallel group clinical trial to examine cannabidiol (CBD) as a pharmacological treatment for cannabis dependence in a young cannabis dependent population.
IRAS ID
128407
Contact name
Ali Mofeez
Contact email
Eudract number
2013-000361-36
Research summary
In Europe, 1% of all adults and nearly 2% of 14-17 year olds are cannabis dependent. Demand for treatment for cannabis has more than doubled in the UK and Europe since 2001. However, providing an effective treatment for cannabis dependence remains an unmet challenge. There is currently no approved pharmacological treatment and psychological treatments have very limited efficacy.\nThe purpose of this non-commercial clinical trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Cannabidiol is a naturally occurring compound in the cannabis plant which appears a promising treatment with an excellent safety profile and very few side effects. Between 96 and 168 young people (16-26) who want to quit cannabis and meet criteria for dependence (moderate ’Cannabis Use Disorder’; Diagnostic & Statistical Manual of Mental Disorders 5) will be recruited from the community.\n\nThe study uses an adaptive design in two stages. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Up to 96 participants aged 16-26 will be allocated to one of four groups receiving cannabidiol (200mg, 400mg, 800mg) or placebo. Stage 1 will finish when MEDmg is identified (if no MED is found, the trial will be stopped here).\nStage 2 will determine whether MED identified in stage 1 can offer an effective treatment for cannabis dependence. Existing placebo and ‘MED’ groups from stage 1 will be expanded by up to a maximum of 60/group.\n\nAll participants will be given psychological therapy to help them quit using cannabis. We will measure drug use, neuropsychological performance, psychological wellbeing and biological parameters (e.g. heart rate; respiratory function) across 4 treatment weeks and follow up for 12 weeks afterwards. Urine and plasma samples will be used to objectively monitor levels of cannabidiol medication and cannabis use.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0303
Date of REC Opinion
12 Nov 2013
REC opinion
Further Information Favourable Opinion