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MDMA-assisted Therapy for Fibromyalgia

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Start date: Jul 1, 2026 to Sep 15, 2026v7
  2. Notable Start date: Apr 1, 2026 to Jul 1, 2026v6
  3. Notable Primary completion date: Mar 2026 to Dec 2026
    • Start date: Jan 1, 2026 to Apr 1, 2026
    • Site contact updated
    v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2024 to Jan 1, 2026
    • Site details revised
    v4
  5. Notable Start date: Mar 2024 to Aug 2024v3
  6. Notable Primary endpoint revised
    • Study description shortened, about 554 words
    • Eligibility criteria shortened, about 2 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06066853
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: Multidisciplinary Association for Psychedelic Studies
Conditions
(from sponsor)
Fibromyalgia
Related terms Fibromyalgia, Pain
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov