Researchers in Kingston, Ontario, have begun a clinical trial that will test whether “microdosing” psilocybin, a hallucinogenic compound found in magic mushrooms, can bring relief to people suffering from generalized anxiety disorder.
Led by a team from the Kingston Health Sciences Center Research Institute.the study is advertised as first phase 2 clinical trial approved by Health Canada to investigate the effects of small daily doses of psilocybin.
We hope to find out whether microdosing May relieve symptoms of anxiety without causing mind-altering side effects, says Dr. Claudio Soares, a professor of psychiatry at Queen's University and lead researcher.
Interest in the medical uses of psychedelics such as psilocybin, ketamine and LSD has grown rapidly in recent years, with research beginning across the country.
But much of this work, Soares said, involved high doses or “macrodoses,” which—because of their hallucinatory effects—require study participants to be monitored in medical settings, sometimes for up to half a day.
“They have this mystical experience and changes in their perception of the environment – what we call a journey,” said Soares, who is also director Center for Health and Psychedelic Research at Kingston Hospital in Providence.
“It's not for everyone. Some people cannot tolerate the effects of psychedelics.”
How this study works
The Kingston study will eventually enroll up to 60 adults with “debilitating” anxiety but no other medical conditions, Soares said.
They will take small doses of psilocybin—about two to three milligrams a day—at home for four weeks. They will then be randomly assigned to either additional microdoses of psilocybin or a placebo for an additional four weeks.
The goal is to see if participants feel well in the first half of the study, then watch for signs of anxiety returning or withdrawal symptoms in the second half, Soares said.
These data could potentially form the basis for larger phase 3 studies, typically the final phase before a drug reaches the market.
It's not uncommon to find someone who says, “Oh, I microdosed psilocybin and I feel so much better.”– Dr. Claudio Soares, Lead Investigator
The study comes as the prevalence of generalized anxiety disorder is rising, more than doubling among people aged 15 and older—from 2.6 per cent to 5.5 per cent—from 2012 to 2022, according to Statistics Canada.
Typical treatments include antidepressants and psychotherapy, but there is a significant group of patients who simply “don't get better” from these approaches, says Dr. Tyler Custer, a psychiatrist and medical director of the Temerty Center for Therapeutic Brain Intervention at Toronto's Center for Addictions and Mental Health (CAMH).
Studying the potential benefits of microdosing psilocybin—though more experimental than most existing studies on macrodosing—is “a really interesting idea,” Custer said.
“The whole field of psychedelics has a lot of promise. There is also a lot of enthusiasm and we need to find out what role, if any, these methods play.”
Destigmatization of hallucinogens
While clinical studies of microdosing psilocybin and anxiety are rare, Soares noted that there have been anecdotal reports of people taking small doses of psilocybin to treat their mental illnesses.
“It’s not uncommon to find someone who says, ‘Oh, I microdosed on psilocybin and I feel so much better,’” Soares said.
“[But there are] there are very few studies looking at microdosing in medical settings, under controlled conditions, [where] we know exactly what people take and for how long [and] what doses?
Both the current study and the center's work have a broader goal: destigmatizing psilocybin and other psychedelics as legitimate medical treatments, Soares said.
“They have been used for recreational or religious purposes for many, many years or centuries. But they have medicinal value, therapeutic value that we need to study,” Soares said.
“Because if we don’t educate ourselves, they will remain underground—and then we won’t exactly know how to use them safely.”
