First Prescriptions Arrive for Europe’s Largest Medical Cannabis Trial
A two-year-long medical cannabis research project, dubbed Project Twenty21, has just received its first batch of medical cannabis products.
Supplied by the Latin American company Khiron Life Sciences, the cannabis products will first be issued to UK doctors before being prescribed to the 20,000 patients expected to be involved in the trial.
Growing a trial
Launched in November last year, Project Twenty21 is intended to be Europe’s largest medical cannabis experiment.
By the end of 2021, the project aims to have tested medical cannabis’ effects on a range of conditions, including chronic pain, epilepsy, multiple sclerosis, post-traumatic stress disorder, Tourette’s syndrome, and anxiety disorder.
It remains unclear whether the initiative will still hit this deadline, considering the coronavirus pandemic, but measures have been put in place to deliver patients’ prescriptions to their homes.
Supported by the Royal College of Psychiatrists, the trial will be overseen by the scientific group Drug Science and headed up by Professor David Nutt.
“Khiron's assistance in delivering Project Twenty21 will expand the formulary significantly,” Nutt said in a statement. “Our shared vision, accelerating access of medical cannabis to patients who need it the most, will be greatly enhanced by the support provided by the Khiron team.”
Getting the evidence
Despite legalizing the use of medical cannabis in November 2018, the UK has only seen a handful of prescriptions. Many UK doctors feel uncomfortable issuing medications they were never educated on, and several public health authorities have given damning conclusions on cannabis’ medical potential.
As a consequence, around 1.4 million Brits are thought to still be sourcing cannabis illicitly to treat a diagnosed medical problem.
Project Twenty21’s aim is to gather enough evidence to prove to policymakers that medical cannabis should be as widely available as other approved medicines for patients who would benefit from them.
However, the project is not a randomized clinical trial with a placebo group – a format considered the gold standard test for proving the clinical efficacy of drugs. Instead, all 20,000 enrolled patients will receive medical cannabis at an affordable cost, subsidized by Drug Science and partnering medical companies.
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 generally preferred by researchers.
“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.”