A new pilot study published in the journal Frontiers in Pain Research finds that psilocybin-assisted therapy may offer a safe and potentially effective treatment option for individuals with fibromyalgia.
Dried psilocybin mushrooms.
Researchers from the University of Michigan, The Ohio State University and Johns Hopkins University conducted an open-label clinical trial involving five adults diagnosed with fibromyalgia. Each participant received two doses of psilocybin—15 mg followed by 25 mg—administered two weeks apart, along with preparatory and integration psychotherapy sessions.
The study’s primary focus was on safety. No serious adverse events occurred, though all participants experienced temporary increases in blood pressure or heart rate during dosing, which normalized by the end of treatment. Four participants reported short-term headaches.
In terms of effectiveness, participants showed meaningful improvements in pain severity, pain interference , and sleep disturbance one month after their final dose. Three of the five individuals described their symptoms as either “very much improved” or “much improved,” while the remaining two reported being “minimally improved.”
Recruitment for the trial was halted early due to concerns about generalizability and recent changes in FDA guidance on psychedelic trials. Still, the findings lay groundwork for future randomized controlled trials examining psilocybin-assisted therapy as a treatment for fibromyalgia.
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