MDMA-assisted Therapy for Fibromyalgia
This study is exploring MDMA-assisted psychotherapy for people with fibromyalgia, a chronic pain condition. Researchers want to see if MDMA, combined with therapy, can help reduce pain severity and how much pain interferes with daily life. They believe MDMA might improve positive emotions and trust between you and your therapist, which could help you think differently about your pain. To join, you need to be between 21 and 65 years old, have a fibromyalgia diagnosis for at least a year, and experience typical pain intensity of 4 out of 10 or higher. You also need to be fluent in English and able to swallow pills. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
- What's involved
- You would have a screening visit to check eligibility, which includes reviewing your medical history, lab tests, a drug screen, a pregnancy test if applicable, a physical exam, and an electrocardiogram (ECG) to check your heart.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your self-reported pain will be assessed at five timepoints over approximately 3 months.
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NCT06066853
MDMA-assisted Therapy for Fibromyalgia
Recruiting
EARLY_PHASE1Ages 21–65InterventionalTreatmentSpaulding Rehabilitation HospitalInvestigator-initiated
~20 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:MDMA
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in self-reported pain severity and pain interference (Brief Pain Inventory)
Measured over BPI will be assessed at five timepoints (Visits 1, 7, 10, 12, and 13) throughout the study, spanning approximately 3 months.
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Vitaly Napadow, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Are at least 21 years to 65 years of age inclusive, at the time of signing the informed consent.
Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year.
Typical fibromyalgia pain intensity of 4/10 or greater.
Fluent in speaking and reading English.
Able to swallow pills.
Agree to have some study visits audiovisually recorded, including Experimental Sessions/ neuroimaging sessions.
Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
Able to identify appropriate support person(s) to stay with the participant on the evenings of the Experimental Sessions
Have a body weight of at least 45 kilograms (kg). Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2
Participants assigned female sex at birth must not be pregnant or become pregnant throughout participation in the study
Capable of giving signed informed consent
Are on stable doses of allowable medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial, except for medications falling under the tapering scheduling
Exclusion
Presence of any medical or psychiatric illness that is judged to interfere with the study (ex. Fibromyalgia, PTSD, bipolar, schizophrenia) determined by a self-report measure.
Presence of any contraindications to fMRI scanning or EEG scanning. (ex. Cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy).
Unwillingness to receive brief experimental pain
Lower extremity pain or vascular issues that may interfere with the study procedures
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.
Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic.
Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.
Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.
Have a current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment.
Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.
Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion.
Unable or unwilling to safely taper-off prohibited psychiatric and non-psychiatric medication with exceptions determined by study staff or require use of prohibited medications during experimental sessions.
Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.
Have used Ecstasy (unregulated material represented as containing MDMA) more than 10 times within the last 10 years, or at least once within 6 months of the first Experimental Session.
Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.
Have current Personality and/or Psychotic Disorders.
Have a current eating disorder with compensatory behaviors.
Have current major depressive disorder with psychotic features.
Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.
Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of fibromyalgia or any psychiatric disorders.
Lack social support or lack a stable living situation.
Previous participation in a MAPS-sponsored MDMA clinical trial.
Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.
Presence of any medical or psychiatric illness that is judged to interfere with trial
Presence of any contraindications to fMRI scanning or EEG scanning (ex. Cardiac pacemaker, metal implants, fear of closed spaces)
Lower extremity pain or vascular issues that may interfere with study procedures
Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
Have any severe anxiety disorders or significant anxiety symptoms interfering with fMRI scanning (e.g. panic)
Is a current patient of the matched dyad clinician enrolled in the study
Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation or prevent satisfactory completion of study protocol.
What this trial measures
- Change in self-reported pain severity and pain interference (Brief Pain Inventory)BPI will be assessed at five timepoints (Visits 1, 7, 10, 12, and 13) throughout the study, spanning approximately 3 months.
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).