MDMA-assisted Therapy for Fibromyalgia

Overseen By Arvina 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MDMA-assisted therapy can improve the relationship between patients and clinicians for those with fibromyalgia, a chronic pain condition. Researchers aim to determine if MDMA can enhance positive emotions and trust, thereby making therapy more effective. Participants will undergo sessions combining MDMA with therapy and neuroimaging. Individuals who have had fibromyalgia for at least a year and experience significant daily pain might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore this innovative therapy.

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.

Is there any evidence suggesting that MDMA-assisted therapy is likely to be safe for humans?

Research has shown that MDMA-assisted therapy has been studied for its safety in treating conditions like post-traumatic stress disorder (PTSD). In these studies, participants generally tolerated MDMA-assisted therapy well. Many did not experience severe side effects, and some even reported emotional improvement.

About two-thirds of those who underwent MDMA sessions with talk therapy experienced a significant reduction in PTSD symptoms. This suggests that the treatment can be safe when conducted in a controlled setting with professional supervision. However, safety information for fibromyalgia is still being gathered.

As this is an early phase study, the primary goal is to assess the safety of MDMA-assisted therapy for fibromyalgia. This phase typically involves fewer participants and aims to ensure the treatment does not cause serious harm. Understanding these safety checks can be reassuring for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for fibromyalgia, which often include medications like pain relievers and antidepressants, MDMA-assisted therapy uses MDMA, a compound known for its psychoactive effects, to potentially address the root causes of pain and emotional distress. This therapy is unique because it combines MDMA with psychological support, aiming to enhance emotional processing and alleviate symptoms in a way that traditional medications may not. Researchers are excited about this approach because it could offer relief more quickly and effectively by targeting both the mind and body, potentially leading to longer-lasting improvements in quality of life.

What evidence suggests that MDMA-assisted therapy might be an effective treatment for fibromyalgia?

Research has shown that therapy using MDMA has potential in treating conditions like post-traumatic stress disorder (PTSD). Specifically, about two-thirds of PTSD patients who participated in MDMA sessions no longer met the criteria for PTSD afterward. While specific data on fibromyalgia is limited, this therapy is believed to enhance positive feelings and improve the relationship between patients and their therapists. This improved interaction might help alter negative thoughts about pain. The hope is that fibromyalgia patients could experience similar benefits, leading to an improvement in their condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Vitaly Napadow, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06066853

NCT06066853 | MDMA-assisted Therapy for Fibromyalgia Based on prior research with MDMA, it can be hypothesized MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions, ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06066853

MDMA-assisted Therapy for Fibromyalgia - Clinical Trial Finder MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions, interpersonal trust, and heighten the state of empathic rapport.

3. withpower.com withpower.com/trial/early-phase-1-fibromyalgia-2-2024-da086

MDMA-assisted Therapy for Fibromyalgia Trial Overview The trial is testing MDMA-assisted therapy's potential to enhance positive emotions and patient-clinician relationships in treating fibromyalgia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9669702/

MDMA-assisted therapy is associated with a reduction in ... Increasing evidence demonstrates that MDMA-assisted therapy (MDMA-AT) may be a safe and effective treatment for post-traumatic stress disorder ( ...

5. bbc.com bbc.com/future/article/20240620-fda-advisors-voted-against-mdma-therapy-researchers-are-still-fighting-for-it

FDA advisors voted against MDMA therapy – researchers ... About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase ...

6. fda.gov fda.gov/media/178984/download

NDA 215455 The primary objective was “to evaluate the long-term effectiveness of MDMA-assisted psychotherapy for the treatment of PTSD.” Following ...