Actively Recruiting
MDMA-assisted Therapy for Fibromyalgia
Led by Spaulding Rehabilitation Hospital · Updated on 2026-03-05
20
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Spaulding Rehabilitation Hospital
Lead Sponsor
M
Multidisciplinary Association for Psychedelic Studies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MDMA-assisted Therapy for Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are between 21 and 65 years old at the time of consent
- Have a clinical diagnosis of fibromyalgia meeting Wolfe et al 2011 research criteria for at least one year
- Experience typical fibromyalgia pain intensity of 4/10 or greater
- Are fluent in speaking and reading English
- Are able to swallow pills
- Agree to some study visits being audiovisually recorded
- Can provide a contact person reachable in case of emergency
- Can identify support person(s) to stay with participant on evenings of Experimental Sessions
- Have body weight of at least 45 kilograms; if 45 to 48 kg, BMI must be between 18 and 30 kg/m2
- Participants assigned female sex at birth must not be pregnant or become pregnant during the study
- Are capable of giving signed informed consent
- Are on stable doses of allowable medications for 30 days prior to study and agree not to change during trial except for tapering
You will not qualify if you...
- Have any medical or psychiatric illness interfering with the study (including PTSD, bipolar, schizophrenia) per self-report
- Have contraindications to fMRI or EEG scanning (e.g., pacemaker, metal implants, claustrophobia, pregnancy)
- Are unwilling to receive brief experimental pain
- Have lower extremity pain or vascular issues interfering with study procedures
- Have current unstable liver or biliary disease
- Have history of medical conditions making sympathomimetic drugs harmful (e.g., heart attack, stroke, severe coronary artery disease, aneurysm)
- Have uncontrolled hypertension (blood pressure ≥140/90 mmHg)
- History of ventricular arrhythmia except occasional PVCs without ischemic heart disease
- Have Wolff-Parkinson-White syndrome or untreated accessory pathways
- History of arrhythmia within 12 months except occasional PACs or PVCs without ischemic heart disease
- Have risk factors for Torsade de pointes
- Started new psychiatric or mental health care within past 12 weeks, including ECT or ketamine therapy
- Have moderate or severe alcohol or cannabis use disorder within past 12 months
- Have active illicit or prescription drug use disorder other than cannabis within past 12 months
- Present serious suicide risk currently
- Unable or unwilling to safely taper prohibited medications
- Require medications that prolong QT interval during experimental sessions
- Used Ecstasy more than 10 times in last 10 years or within 6 months before first experimental session
- Currently enrolled in other investigational clinical studies without approval
- Have current Personality or Psychotic Disorders
- Have eating disorder with compensatory behaviors
- Have major depressive disorder with psychotic features
- Have history or current primary psychotic disorder or bipolar type 1
- Are sensitive or allergic to study interventions
- Engaged in compensation litigation related to fibromyalgia or psychiatric disorders
- Lack social support or stable living situation
- Previously participated in a MAPS-sponsored MDMA trial
- Are employees or related to employees of MAPS or investigators
- Have comorbid chronic pain rated more painful than fibromyalgia
- Have severe anxiety interfering with fMRI
- Are current patients of study clinicians
- Pose serious risk to others per clinical judgment
- Have any other condition interfering with participation or study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lara Gardiner
CONTACT
A
Arvina Grahl, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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