from Reuters Website
The world's first clinical trial designed to explore using a hallucinogen from magic mushrooms to treat people with depression has stalled because of British and European rules on the use of illegal drugs in research.
David Nutt, president of the British Neuroscience Association and professor of neuropsychopharmacology at Imperial College London, said he had been granted an ethical green light and funding for the trial, but regulations were blocking it.
He has previously conducted small experiments on healthy volunteers and found that psilocybin, the psychedelic ingredient in magic mushrooms, has the potential to alleviate severe forms of depression in people who don't respond to other treatments.
Following these promising early results he was awarded a 550,000 pounds ($844,000) grant from the UK's Medical Research Council to conduct a full clinical trial in patients.
But psilocybin is illegal in Britain, and under the United Nations '1971 Convention on Psychotropic Substances' it is classified as a Schedule 1 drug - one that has a high potential for abuse and no recognized medical use.
This, Nutt explained, means scientists need a special license to use magic mushrooms for trials in Britain, and the manufacture of a synthetic form of psilocybin for use in patients is tightly controlled by European Union regulations.
Together, this has meant he has so far been unable to find a company able to make and supply the drug for his trial, he said.
Nutt said regulatory authorities have a "primitive, old-fashioned attitude that Schedule 1 drugs could never have therapeutic potential", despite the fact that his research and the work done by other teams suggests such drugs may help treat some patients with psychiatric disorders.
Psilocybin - or "magic" - mushrooms grow naturally around the world and have been widely used since ancient times for religious rites and also for recreation.
Researchers in the United States have seen positive results in trials using MDMA, a pure form of the party drug ecstasy, in treating post-traumatic stress disorder.
The proposed trial would involve 60 patients with depression who have failed two previous treatments.
During two or three controlled sessions with a therapist, half would be given a synthetic form of psilocybin, and the other 30 a placebo. They would have guided talking therapy to explore negative thinking and issues troubling them, and doctors would follow them up for at least a year.
Nutt secured ethical approval for the trial in March.
In previous research, Nutt found that when healthy volunteers were injected with psilocybin, the drug switched off a part of the brain called the anterior cingulate cortex, which is known to be overactive in people with depression.
By David Nutt: