In a small open-label pilot trial, five people with fibromyalgia received two doses of psilocybin (15 mg and 25 mg) along with psychotherapy. The treatment was well-tolerated: there were temporary increases in blood pressure or heart rate during dosing that returned to normal, no serious adverse events, and four of five participants had short-lived headaches. One month after the second dose, participants reported large reductions in pain severity, pain interference, and sleep disturbance. One participant rated their symptoms as very much improved, two as much improved, and two as minimally improved. Recruitment stopped early due to generalizability concerns and changing FDA guidance, but the results suggest psilocybin-assisted therapy is safe for fibromyalgia and warrants larger trials.
In a small open-label proof-of-concept trial, five adults with fibromyalgia received two doses of psilocybin (15 mg and 25 mg) two weeks apart, along with psychotherapy sessions. No serious adverse events occurred; transient blood pressure or heart rate elevations during dosing resolved by the end of treatment, and four of five participants had temporary headaches. One month after the second dose, participants reported clinically meaningful improvements in pain severity, pain interference, and sleep disturbance. One participant rated their symptoms as very much improved, two as much improved, and two as minimally improved. Improvements were also seen in fibromyalgia symptoms, anxiety, and fatigue. The findings suggest psilocybin-assisted therapy is well-tolerated and warrants larger randomized controlled trials.