Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-assisted Therapy for Fibromyalgia
Spaulding Rehabilitation Hospital
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.
Description
If the participant agrees to engage in this research study, they will be asked to complete the following study visits: Screening (Visit 1): At this visit the participant will review and sign the consent form. If informed consent is given, the investigators will proceed to screening. During screening, the study personnel will decide if eligibility criteria are met. The study staff will ask about medical and psychiatric history, medications, and any other conditions. They will then further assess eligibility through clinical lab tests, a drug screen, and pregnancy test for those able to become…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugMDMA
MDMA-assisted psychotherapy
Location
- Massachusetts General HospitalCharlestown, Massachusetts