MDMA-assisted Therapy for Fibromyalgia

This single-arm open-label trial (n=20) will assess the efficacy of MDMA-assisted psychotherapy for fibromyalgia patients.

Conducted by Spaulding Rehabilitation Hospital in collaboration with the Multidisciplinary Association for Psychedelic Studies (MAPS), the study aims to explore how MDMA-assisted therapy may enhance the patient-clinician interaction, promote positive emotions and interpersonal trust, and initiate reattribution processes targeting dysfunctional thoughts towards pain.

Participants, aged 21 to 65, diagnosed with fibromyalgia and meeting specific criteria, will undergo two experimental sessions of therapy with MDMA combined with neuroimaging, integrative therapy, baseline neuroimaging, and a 3-month follow-up. The trial consists of various study visits, including screening, baseline EEG and MRI, preparatory sessions, experimental sessions, and follow-up.

Primary outcome measures include changes in self-reported pain severity and pain interference assessed using the Brief Pain Inventory at five time points throughout the study. Recruitment is expected to start in March 2024, with an estimated study completion in December 2026.

Topic Fibromyalgia
Compound MDMA
Country United States of America
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Trial Details



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Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Data attribution

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