Randomised, double-blind, parallel-group study (n=30) testing a single oral dose of psilocybin (0.36 mg/kg) versus active placebo (dextromethorphan 2.6 mg/kg) for fibromyalgia.
Randomised, double-blind, parallel-group trial evaluating psilocybin-assisted treatment for fibromyalgia with 30 female participants, comparing 0.36 mg/kg psilocybin to 2.6 mg/kg dextromethorphan (active placebo).
Participants receive preparatory therapy (minimum two 2-hour sessions), a single 8‑hour supervised dosing session with physiological monitoring, and an integration session the following day; outcomes include pain, fatigue, functioning and quality of life.
Additional measures assess potential mediators such as expectations, pain characteristics, personality and cognitive/emotional factors; participants complete follow-up at ~6 weeks.
Single oral psilocybin administration (0.36 mg/kg) in treatment-seeking fibromyalgia patients.
Administered once during an 8-hour dosing session; participants receive preparatory and integration sessions.
Oral dextromethorphan (active placebo) 2.6 mg/kg.
Active placebo: dextromethorphan (DXM) 2.6 mg/kg; participants blinded to drug assignment; unblinded at study end.