Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Adults aged 21-65 with a clinical diagnosis of fibromyalgia, experiencing typical pain intensity of 4/10 or greater, and meeting specific research criteria. Participants must be fluent in English, able to swallow pills, not pregnant, on stable medication doses for 30 days prior to the study without changes during the trial (except for tapering schedules), and have a support person available post-session.Inclusion Criteria
Fluent in speaking and reading English
Agree to have some study visits audiovisually recorded, including Experimental Sessions/neuroimaging sessions
I am not and will not become pregnant during the study.
+10 more
Exclusion Criteria
I do not have severe liver problems like ascites, jaundice, or cirrhosis.
You have been diagnosed with a moderate or severe alcohol or cannabis use disorder in the past year.
You have been using illegal drugs or misusing prescription drugs in the past year.
+33 more
Participant Groups
The trial is testing MDMA-assisted therapy's potential to enhance positive emotions and patient-clinician relationships in treating fibromyalgia. It includes two experimental sessions with MDMA therapy combined with neuroimaging studies, alongside integrative therapy sessions and follow-ups over three months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalCharlestown, MA
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Who Is Running the Clinical Trial?
Spaulding Rehabilitation HospitalLead Sponsor
Lykos TherapeuticsCollaborator
Multidisciplinary Association for Psychedelic StudiesCollaborator