Tom P Freeman, Chandni Hindocha, Gianluca Baio, Natacha D C Shaban, Emily M Thomas, Danica Astbury, Abigail M Freeman, Rachel Lees, Sam Craft, Paul D Morrison, Michael A P Bloomfield, Dominic O’Ryan, Jane Kinghorn, Celia J A Morgan, Ali Mofeez, H Valerie Curran
July 28, 2020
A benchmark clinical trial published today shows that cannabidiol (CBD) could be a safe and effective treatment for problematic cannabis use.
Results from the first-ever randomised clinical trial of CBD for cannabis use disorder suggests that prescribed doses of the non-intoxicating constituent part of the cannabis plant could help people kick the habit.
In the MRC-funded trial, published today in the Lancet Psychiatry, researchers administered doses of CBD or placebo to 82 volunteers who were motivated to quit using cannabis but had previously failed to do so. They measured the effects of the drug on levels of cannabis use both during a four-week treatment period and up to six months follow-up.
As this was the first clinical trial to assess CBD for reducing cannabis use, they tested three different doses of CBD in an adaptive design to find out which doses might be most effective.
- In the first stage of the trial, 48 volunteers received either placebo or CBD at doses of 200mg, 400mg or 800mg. The researchers found that the lowest dose of 200mg CBD was ineffective and so they dropped it from the trial.
- In the second stage of the trial, the researchers recruited an additional 34 volunteers to receive either placebo, 400mg or 800mg CBD. At the end of the trial, they found consistent evidence that CBD at 400mg or 800mg was more effective than placebo at reducing cannabis use.
Their results showed that participants treated with CBD showed lower levels of cannabis in their urine and an increased number of days abstinent compared to those treated with placebo.
CBD was well tolerated at all doses and there were no increases in side effects compared to placebo. 94% of the volunteers completed treatment. Importantly, the doses of CBD tested were significantly higher than CBD products purchased online or from the High Street (typically 25mg per day).
All participants in the trial met a clinical diagnosis of cannabis use disorder, indicating a problematic pattern of cannabis use which had created significant impairment and distress for the individual. All participants had previously failed to quit cannabis use at least once and took part in the trial as part of a cessation attempt.
Lead author Dr Tom Freeman, Director of the Addiction and Mental Health Group within the Department of Psychology at the University of Bath explains: “The results from our trial open up a novel therapeutic strategy for managing problematic cannabis use in clinical settings. As we highlight, CBD at daily oral doses of 400mg and 800mg has the potential to address the substantial and currently unmet clinical need for a pharmacological treatment of cannabis use disorders”
“Whilst it may seem counterintuitive to treat problematic cannabis use with CBD – a constituent part of the cannabis plant – THC and CBD have contrasting effects on our own endogenous cannabinoid system. Unlike THC, CBD does not produce intoxicating or rewarding effects and it shows potential for treating several other medical disorders.”
Cannabis is now the primary drug cited by first-time clients presenting at addiction services across Europe, with the number of people entering treatment increasing by 76% over the past decade. The increase in treatment for cannabis problems has occurred alongside an increase in concentrations of THC, the intoxicating component of cannabis. Daily use of cannabis with high THC concentrations is associated with a five-times increased risk of psychosis.
At present there are no recommended pharmacotherapies to help people with problematic cannabis use to quit. In demonstrating how CBD could be a promising treatment strategy, this trial adds to existing research on the potential medicinal uses of CBD including the treatment of severe childhood epilepsy syndromes and psychosis. Importantly, treatment with CBD does not include any of the intoxicating constituent of cannabis (THC) which might carry a risk of adverse effects.
Professor Valerie Curran, senior author and Director of the Clinical Psychopharmacology Unit at UCL, said: “Our findings indicate that CBD doses ranging from 400mg to 800mg daily have the potential to reduce cannabis use in clinical settings, but higher doses are unlikely to bring any additional benefit. Larger studies are needed to determine the magnitude of the benefits of daily CBD for reducing cannabis use.”
In November 2019, Drug Science launched Europe’s first and biggest national medical cannabis registry, called Project Twenty21. An indication that will be included in this registry will be patients suffering from Substance Use Disorder. This will include patients using recreational cannabis and substituting that use with CBD only and CBD rich products.
NOTES TO EDITORS
The study was funded by the Medical Research Council and was conducted at University College London (UK). Researchers were from UCL, the University of Bath (UK), Kings College London (UK), National Institute for Health Research UCL Hospitals Biomedical Research Centre (UK), Camden and Islington National Health Service Foundation Trust (UK) and the University of Exeter (UK).
The full paper ‘Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial’ is published in the Lancet Psychiatry thelancetpsych-D-20-00395