Double-blind, randomised Phase II trial (n=44) comparing single oral low doses of psilocybin (5 mg, 10 mg) versus placebo to assess effects on pain tolerance and painfulness in fibromyalgia patients and healthy volunteers.
Randomised, double-blind, placebo-controlled multicentre trial (single site in the Netherlands) with three arms (psilocybin 5 mg, psilocybin 10 mg, matched placebo) evaluating pain tolerance and subjective painfulness in fibromyalgia patients and healthy volunteers.
Primary outcomes include pain tolerance (seconds), pressure pain threshold and subjective painfulness ratings measured at 1.5 and 4 hours post-administration; secondary outcomes cover mood, cognition, personality and psychedelic experience with follow-up assessments.
Participants must meet BMI and diagnostic criteria (fibromyalgia group) or have no major medical/psychiatric conditions (healthy volunteers); placebo capsules are matched to active psilocybin capsules.
Single oral capsule of 5 mg psilocybin versus placebo.
Capsule (5 mg)
Single oral capsule of 10 mg psilocybin versus placebo.
Capsule (10 mg)
Matched oral capsule placebo.
Matched capsule placebo