An Early Phase 1 interventional study of MDMA in Fibromyalgia, sponsored by Spaulding Rehabilitation Hospital. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Spaulding Rehabilitation Hospital · Early Phase 1, Interventional, and Treatment
Among 369 studies in Fibromyalgia with a site in United States — 52 open to participants now, 63 under way, 2 of them phase 3. Fibromyalgia · United States.
Among the 369 studies in Fibromyalgia with a site in United States, this one is the 268th largest by planned enrollment of the 320 interventional ones that give a count, is one of 20 that started in 2026, is one of 15 in phase 1, reaches primary completion later than 12 of the 62 other live ones, and was the 329th registered.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →52 of the 369 studies in Fibromyalgia with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Pulkit Grover · Sites in United States
Theranica · Sites in United States, Israel
Icahn School of Medicine at Mount Sinai · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 21 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
369 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 61 · Phase 3 64 · Phase 4 24
First in 1994; this study’s year is marked. 20 started in 2026.
This study's planned enrollment of 20 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Median enrollment 72 across the 320 interventional studies, 200 across the 47 observational. Of the 276 that completed or were terminated, 116 (42%) have results posted.
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101 of 369 have an industry lead sponsor. The 10 most frequent:
Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
Spaulding Rehabilitation Hospital has 5 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
29 of the studies in Fibromyalgia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT07116278University of California, San FranciscoTMS-EEG Biomarkers for Chronic Pain | 2026-12 |
| NCT04949100Paul CrawfordMicrocurrent for Fibromyalgia | 2026-12 |
| NCT07525063Duke UniversityPain & Reward Neuromodulation of CNS Circuits | 2026-12 |
| NCT06552728University of California, IrvineThe Effects of Energy Healing in Fibromyalgia | 2026-12 |
Among the 369 studies in Fibromyalgia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 pregnant. The drug screen will include at minimum: amphetamines, barbiturates, cocaine, opioids, cannabinoids, and benzodiazepines. Participants will also complete a symptom-directed physical exam and vitals (blood pressure, temperature, and respiratory and heart rate) will be assessed. An electrocardiogram (ECG), a test that measures the rhythm and rate of the heart, will be performed. Additional cardiovascular evaluation and risk mitigation will be completed to determine eligibility if the participant has cardiac risk factors, but no other evidence of significant cardiovascular or cerebrovascular disease.
At the screening visit study staff will measure the participant's responses to pressure pain, using an inflatable cuff that is placed on the lower leg. Different pressure intensities to inflate the cuff will be used. The participant will be asked to complete several questionnaires that will assess personality and other traits along with questionnaires to assess pain. Participants found eligible after the screening visit will be enrolled in the study.
All participants are required to identify a support person. This person will be responsible for staying with the participant on the evenings of the experimental sessions and will meet with the therapy team to receive training regarding their role. All participants will also be required to identify an escort, who will accompany the participant to and from the study site for each experimental session. This may be the same person as the support person, or it may be someone else.
Baseline EEG and MRI (Visits 2 and 3):
Following enrollment, participants will complete a baseline electroencephalography (EEG) scan followed by a functional magnetic resonance imaging (fMRI) scan. At the EEG scan participants will be asked to view and reflect on various statements and to complete a cuff pressure task, in which they will receive various cuff pressures to their left leg. While participants are doing these tasks, the activity of the brain will be monitored using EEG and vitals will be measured.
At the fMRI scan participants will be asked to change out of their clothes and into an MRI-compatible hospital gown and pants to ensure safety. They will be asked to remove any metal objects including jewelry, any piercings, and hair pins. Participants will be given earplugs to reduce the loud noises of the MRI machine. Participants will be able to communicate with the study doctors and MRI staff during the procedures. While in the scanner, participants will complete the same tasks as described in the EEG session. The clinician will be positioned in a different scanner, and video transfer between the two scanners will enable the patient and clinician to view one another's face on a screen for some of the tasks.
In order to quality check the interaction between the patient and the clinician, parts of these scans will be recorded on a videotape.
Preparatory Period (Visits 4-6):
Following baseline scans, participants will undergo three weekly preparatory sessions, with each session lasting about 90 minutes. During these visits participants will meet with their therapy team to learn more about fibromyalgia and develop rapport with their clinicians. The therapy team will help prepare participants for the experimental visits. During this period, participants will undergo medication tapering if necessary. Prior to the final preparatory session, the investigators will do a final assessment of eligibility and confirm that all medication tapering is complete.
Experimental Period (Visits 7-12):
The experimental period will consist of two MDMA-assisted therapy sessions and four integrative sessions. Each of the experimental sessions will last for about 8 hours. At the beginning of the experimental sessions, participants will complete a symptom-directed physical exam, a urine drug screen, and a pregnancy test if applicable. These tests must be negative for the visit to proceed. Participants will be asked to confirm they have not consumed nicotine or caffeine for the past 2 hours and have not consumed food for the past 10 hours. They will complete several questionnaires and will have a quick interview with the therapy team to discuss goals, intentions, and concerns related to the MDMA-assisted therapy session. Vitals will be recorded just before drug administration.
Participants will receive an initial dose of 100 mg of MDMA. They will swallow capsules of study drug with water under the supervision of study staff. The participant will sit or recline on comfortable furnishings and complete MDMA-assisted therapy with their clinicians. A supplemental dose of 50 mg of study drug will be administered 1.5 to 2 hours after the initial dose as seen fit by the therapy team.
About three hours post initial drug administration participants will have an EEG (Visit 7) or fMRI (Visit 10) scan. Throughout these scans participants will remain in contact with their therapy team. These scans will be include the same tasks and procedures as the baseline scans. Following the EEG or fMRI scan, participants will remain with the therapy team until the study drug effects have subsided, their vitals are stable, and their support person or escort has arrived.
Following each experimental visit there will be two integrative sessions, which will consist of 90 minutes of therapy. At these visits participants will discuss and review events from the experimental session. One of the integrative visits (Visit 11) will include an EEG scan during the therapy session.
Follow-up (Visit 13):
About four weeks after the final integration session, participants will be asked to complete a virtual follow-up visit to complete a short interview and answer some final questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MDMA-assisted psychotherapy
Change in self-reported pain severity and pain interference (Brief Pain Inventory)
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).
Time frame: BPI will be assessed at five timepoints (Visits 1, 7, 10, 12, and 13) throughout the study, spanning approximately 3 months.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: N-Methyl-3,4-methylenedioxyamphetamine
Spaulding Rehabilitation Hospital →