April 7 (Bloomberg) -- A clinical trial of psilocybin, the active ingredient in “magic mushrooms,” as a possible treatment for depression is being delayed by U.K. and European regulations, the study’s lead researcher said.
Rules governing illegal drugs in research are stalling the start of a trial, said David Nutt, president of the British Neuroscience Association. The study is being delayed even though it has received 550,000 pounds ($843,000) in funding from the U.K. Medical Research Council, said Nutt, who is also a professor of neuropsychopharmacology at Imperial College London.
The U.K. classifies psilocybin as a Class A drug, Nutt said. That means a special license needs to be obtained to use the substance in research. The manufacturing of a synthetic for use in patients is also tightly controlled by EU rules, he said.
“Finding companies who could manufacture the drug and who are prepared to go through the regulatory hoops to get the license, which can take up to a year and triple the price, is proving very difficult,” Nutt told reporters at an April 5 briefing ahead of a conference on neuroscience today in London.
Experiments published last year involving healthy volunteers have suggested psilocybin lowers activity in the brain’s medial prefrontal cortex, which is hyperactive in depression, and also enhances recollections of positive personal memories.
Magic mushrooms, also known as “shrooms,” have been used for centuries in healing ceremonies and were employed extensively in psychotherapy in the 1950s. The fungi, favored by former Harvard University psychologist Timothy Leary, who founded the Harvard Psilocybin Project, are typically eaten but can also be dried and smoked or made into a tea.
Nutt plans to give 30 patients 2 milligrams of psilocybin, or about the equivalent of five mushrooms, and compare the results with 30 patients taking a placebo. A second dose may be given six months later, he said. The ingredient will be given intravenously.
The rules on clinical trials may be less strict in the U.S., though the threat of litigation there in the event of harm to a patient presents too great a risk for the study’s funders, Nutt said.
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