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Psilocybin-facilitated Treatment for Chronic Pain

Not yet recruitingRegisteredCTG

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.

Details

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.

Topics:Fibromyalgia

Registry

Registry linkNCT05068791