Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Fibromyalgia, sponsored by Spaulding Rehabilitation Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Brief Pain Inventory (BPI) is a validated 16 item questionnaire designed to assess the severity and interference of pain experienced. Pain severity is assessed on a scale from 0 (no pain) to 10 (severe pain). Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).
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 |
What NCT06066853 shows while recruiting
NCT06066853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06066853's enrollment target sits among peer trials
20 69th of 76 higher than 8 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Two Point Discrimination
ACTIVE NOT RECRUITING · Early Phase 1
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
Auricular Neuromodulation in Veterans With Fibromyalgia
RECRUITING · NA
-
Nitrous Oxide as Treatment for Fibromyalgia
RECRUITING · Phase 2
-
The Benefits of Natural Medicine, Vitamin IV Therapy and Supplements: Maintaining Good Health Through Nature
RECRUITING
-
Effects of Breathing and Attention Training (BAT) on Pain Modulation
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI