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NCT06066853 · ClinicalTrials.gov registry record · Early Phase 1
MDMA-assisted Therapy for Fibromyalgia
A Early Phase 1 study of Fibromyalgia, sponsored by Spaulding Rehabilitation Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06066853 is a Early Phase 1 study of Fibromyalgia that is actively recruiting participants, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 20 participants, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06066853, a Early Phase 1 study of Fibromyalgia, is actively recruiting participants, sponsored by Spaulding Rehabilitation Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG MDMA
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06066853
The ClinicalTrials.gov registry entry for NCT06066853 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (89% lower). The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 1 intervention - of which MDMA is the first listed.
NCT06066853 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06066853 about?
NCT06066853 is a clinical study titled "MDMA-assisted Therapy for Fibromyalgia". 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 pat...
What is the current status of trial NCT06066853?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04-01. Estimated completion is 2026-12.
What conditions does trial NCT06066853 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT06066853?
The interventions under investigation include: MDMA (DRUG).
Who is sponsoring clinical trial NCT06066853?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06066853 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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