Europe’s Largest Medical Cannabis Trial Has Begun
Project Twenty21, a two-year-long medical cannabis research project in the UK, has gone live.
Announced in November of last year by the group Drug Science, Project Twenty21 aims to assess how effective cannabis is at treating chronic pain, anxiety disorder, multiple sclerosis, post-traumatic stress disorder, Tourette’s syndrome, and substance use disorder.
While not a randomized, controlled clinical trial – which is considered the gold standard method or procuring clinical evidence – the project does intend to create the largest body of evidence in Europe for the safety and efficacy of medical cannabis by recruiting 20,000 patients to its registry.
During June 2020, the Project Twenty21 team opened up access to its first partnered clinic, the Medical Cannabis Clinics, for 100 patients and commenced beta testing of the patient pathway.
To join the patient registry, participants must have one of the listed conditions (epilepsy, multiple sclerosis, etc.) as recorded by a doctor, and they must have tried at least two other medications to treat their condition to no avail.
As of late June, 7,000 people had signed up for the project’s registry, although they will need to fund the cost of their consultations (capped at £150/US $187) at the partnered clinics.
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 Professor David Nutt, the project’s lead.
During his presentation at the virtual Prohibition Partners cannabis conference in June, 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.
Not a trial
Medical cannabis prescriptions have been legal in the UK since November 2018. But, to date, there have only reportedly 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, such clinical trials aren’t necessarily feasible for studying cannabis on a large scale.
“We’re in this ridiculous position now,” Nutt said during his June presentation. “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. 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 Twenty21 – 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.”