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RECRUITING
NCT06066853
EARLY_PHASE1

MDMA-assisted Therapy for Fibromyalgia

Sponsor: Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-assisted Therapy for Fibromyalgia

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04-01

Completion Date

2026-12

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

MDMA

MDMA-assisted psychotherapy

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States