7,000 Sign Up for Europe’s Largest Medical Cannabis Trial
Over 7,000 people have now signed up to a two-year-long medical cannabis research project in the UK.
Dubbed Project 21, the initiative intends to be Europe’s largest medical cannabis experiment.
7,000 and counting
Launched in November of last year by the group Drug Science, Project 21 aims to assess medical cannabis’ effectiveness at treating a range of conditions, including chronic pain, epilepsy, multiple sclerosis, post-traumatic stress disorder, Tourette’s syndrome, and anxiety disorder.
Participants will detail their responses to the treatments via digital data collection platforms, such as CB2 Insights. These data could then be used to help justify medical cannabis prescriptions in the UK, says Drug Science.
“The 21 basically stands for the idea that we might get 20,000 patients through this registry by the end of 2021,” explained Professor David Nutt, the project’s lead, during his presentation at Prohibition Partners Live on June 23.
“We know over a million people [in the UK] are using these drugs each day, and currently we’ve got 7,000 people signed up. So we’re in the process of opening up the access to a lot of people.”
During his presentation at the virtual cannabis conference, Nutt announced that the project had already helped train 15 UK doctors in how to prescribe the cannabis medications, which will consist of products from partnered companies, such as Alta-flora and Cellen Therapeutics.
The cost of the medications has been capped at £150 (roughly $187 dollars US) per month for the participants – a price judged to be equivalent to what consumers pay in the country’s illicit market.
Not a trial
Medical cannabis prescriptions have been legal in the UK since November 2018. But, to date, there have only been 12 prescriptions given through the country’s National Health Service, and fewer than 50 from private clinics.
Several public health bodies in the country, including the National Institute for Health and Care Excellence (NICE), have called for more randomized, controlled clinical trials to be carried out in the UK before cannabis can be more regularly prescribed. But, according to Nutt, this desire hasn’t always been consistent.
“NICE has very many great attributes,” he said during his presentation. “But let’s remember, even when traditional clinical trials for cannabis medications – initially Sativex – were performed by GW Pharma, NICE basically denied access because they said they were too expensive.”
According to Nutt, these difficulties are partly why Project 21 was never designed to be a randomized, controlled clinical trial.
“We’re in this ridiculous position now. We have set a cost bar which makes it very hard for companies to get under if they’re going to do big, multi-center clinical trials that NICE want,” Nutt said. “This has effectively eliminated all research into cannabis.”
Speaking to Analytical Cannabis last November, Dr Amir Englund, a postdoctoral cannabis researcher at King's College London – who is not involved in Project 21 – explained why randomized clinical trials are still generally preferred by researchers and health professionals.
“There might be all sorts of benefits from cannabis,” Englund said. “But the problem we see in research is all the hype that's being built around cannabis… with that comes a potential for a very strong placebo effect.”
“And that's one of the key sticking points when it comes to a field like medicinal cannabis research: a lot of studies don't have a placebo comparison, or [are] based on people who go to dispensaries and use for their own medical conditions and their own self-reports of cannabis.”