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Compensation: Varies

Number of Visits: 13

20 Participants Needed

MDMA-assisted Therapy for Fibromyalgia

Overseen ByArvina Grahl, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Psychiatric medications

Disqualifiers: PTSD, Bipolar, Schizophrenia, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

Participants must be on stable doses of allowable medications for 30 days before the study and agree not to change medications or dosages during the trial, except for those that need to be tapered off as determined by the study staff.

What data supports the effectiveness of MDMA-assisted Therapy for fibromyalgia?

While there is no direct evidence for MDMA-assisted therapy in fibromyalgia, research on similar treatments like cannabis shows potential benefits in reducing pain and improving quality of life for fibromyalgia patients. Additionally, combining different therapies, including psychological and physical treatments, has shown positive results in managing fibromyalgia symptoms.¹ ² ³ ⁴ ⁵

How does MDMA-assisted therapy differ from other treatments for fibromyalgia?

MDMA-assisted therapy is unique because it combines the use of MDMA, a psychoactive substance, with psychotherapy to potentially address both the psychological and physical symptoms of fibromyalgia, unlike traditional treatments that primarily focus on symptom management with medications or physical therapies.² ⁴ ⁵ ⁶ ⁷

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.

Research Team

Vitaly Napadow, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

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.

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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.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Neuroimaging

Participants complete baseline EEG and fMRI scans to assess brain activity

1 week

2 visits (in-person)

Preparatory Period

Participants undergo preparatory sessions to develop rapport with clinicians and prepare for experimental sessions

3 weeks

3 visits (in-person)

Experimental Period

Participants undergo two MDMA-assisted therapy sessions and four integrative therapy sessions

4 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

Treatment Details

Interventions

MDMA-assisted Therapy

Trial Overview 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

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Lykos Therapeutics

Collaborator

Trials

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

Recruited

1,200+

Findings from Research

In a study of 306 patients with fibromyalgia, those treated with cannabis-based medicinal products (CBMPs) showed significant improvements in health-related quality of life over 1, 3, 6, and 12 months (p < .0001).

The most common side effects reported were fatigue, dry mouth, concentration impairment, and lethargy, indicating that while CBMPs were generally well-tolerated, some patients experienced notable adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of clinical outcomes in patients with fibromyalgia: Analysis from the UK Medical Cannabis Registry.Wang, C., Erridge, S., Holvey, C., et al.[2023]

Fibromyalgia is a complex disorder often associated with depression, with studies showing that 50-80% of individuals with fibromyalgia may experience depressive symptoms, highlighting the need for a comprehensive treatment approach.

Effective management of fibromyalgia typically involves a combination of therapies, including physical activity, psychosomatic treatments, and various drug-free methods like cognitive-behavioral therapy and relaxation techniques, tailored to meet individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Briquet syndrome in patients with fibromyalgia].Just, M., Ogłodek, E.[2013]