MDMA-assisted Therapy for Fibromyalgia

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06066853
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MDMA — DRUG
    MDMA-assisted psychotherapy

Study 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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Change in self-reported pain severity and pain interference (Brief Pain Inventory) [ Time Frame: BPI will be assessed at five timepoints (Visits 1, 7, 10, 12, and 13) throughout the study, spanning approximately 3 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02114
Lara Gardiner
[email protected]
617-952-6483
Arvina Grahl, PhD
[email protected]

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Massachusetts General Hospital· Charlestown, MA

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