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.

Trial Details

Fibromyalgia is a debilitating chronic pain disorder. Based on prior research with MDMA, it can be hypothesized MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions, interpersonal trust, and heighten the state of empathic rapport that can lead to an enhanced patient-clinician interaction and to initiate reattribution processes targeting dysfunctional thoughts towards pain. Therapeutic alliance, i.e. a positive patient-clinician relationship, is already acknowledged as an essential component for MDMA-assisted therapy. Despite its importance, the patient-clinician interaction and the neuroscience supporting patient/clinician therapeutic alliance has received almost no attention in MDMA research. The investigators will examine the potential therapeutic benefit of MDMA-assisted therapy for fibromyalgia. Additionally, this study will also target secondary objectives including the investigation of the clinical and physiological response (i.e. brain-to-brain concordance) supporting enhanced patient-clinician therapeutic alliance in fibromyalgia patients. The study includes two Experimental Sessions of therapy with MDMA combined with neuroimaging, along integrative therapy, baseline neuroimaging, and a 3 month follow up.

NCT Number NCT06066853

Data attribution

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