Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action (Psilopain)
This open-label trial (n=20) will take EEG measures on participants who receive two doses of psilocybin (up to 25mg). Next to the brain measures, participants will be studied up to six months later.
Details
This mechanistic, within-subjects study in people with fibromyalgia examines EEG-measured brain biomarkers of plasticity following two oral psilocybin sessions (up to 25 mg each) separated by four weeks.
Primary end-point is assessed eight weeks after the first dosing session; participants are then remotely monitored monthly for six months to capture longer-term effects and safety.
In-dosing EEG recordings and secondary mechanistic measures will be used to evaluate candidate biomarkers; psychological and physical therapeutic support is provided alongside dosing.