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MDMA-assisted Therapy for Fibromyalgia
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This single-arm open-label trial (n=20) will assess the efficacy of MDMA-assisted psychotherapy for fibromyalgia patients.
Details
Open-label, single-group study in 20 adults with fibromyalgia evaluating two MDMA-assisted therapy sessions paired with EEG/fMRI and integrative therapy.
Participants complete baseline EEG/fMRI, three 90-minute preparatory sessions, two 8-hour experimental MDMA sessions (100 mg initial, optional 50 mg supplemental at 1.5–2 h), four 90-minute integrative sessions, and a 3‑month follow-up.
Primary outcomes include clinical pain and function; secondary objectives examine patient–clinician neural concordance and therapeutic alliance using neuroimaging and behavioural measures.
Topics:Fibromyalgia
Registry
Registry linkNCT06066853