Early Phase 1 Fibromyalgia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 21 to 65 years old at the time of signing consent forms
• People who have been officially diagnosed with fibromyalgia and have had it for at least one year, meeting specific research diagnostic criteria from 2011
• People whose typical fibromyalgia pain rates at least 4 out of 10 in intensity
• People who are fluent in speaking and reading English
• People who are able to swallow pills
• People who agree to have some study visits recorded on audio and video, including brain scanning sessions
• People who can provide a contact person (such as a relative, spouse, close friend, or other support person) who can be reached by the study team if needed
• People who can arrange for a support person to stay with them on the evenings of the main experimental sessions
• People who weigh at least 45 kilograms; those between 45 and 48 kilograms must also have a body mass index (BMI) between 18 and 30 kg/m²
• People assigned female sex at birth who are not pregnant and agree not to become pregnant during the study
• People who are able to give their own informed, signed consent to participate
• People who have been on stable, permitted medication doses for at least 30 days before joining and agree not to change medications or doses during the trial, except where a gradual dose reduction is scheduled by the study team

Who may not be able to join:

• People with a medical or psychiatric condition judged likely to interfere with the study, such as PTSD, bipolar disorder, or schizophrenia (confirmed by a self-report assessment)
• People with any physical or medical reason they cannot safely undergo MRI or EEG brain scanning (for example, a cardiac pacemaker, metal implants, or a strong fear of enclosed spaces)
• People who are unwilling to receive brief, controlled experimental pain as part of the study procedures
• People with pain or blood vessel problems in their lower limbs that could interfere with study procedures
• People with a currently unstable liver or bile duct condition, as assessed by the study doctor
• People with a history of any medical condition that could make it unsafe to receive a drug that raises blood pressure and heart rate — including but not limited to heart attack, stroke, heart failure, severe coronary artery disease, or aneurysm
• People with uncontrolled high blood pressure, defined as repeated readings of 140 mmHg or higher (top number) or 90 mmHg or higher (bottom number)
• People with a history of a serious type of irregular heartbeat called ventricular arrhythmia, except for occasional minor irregularities not linked to heart disease
• People with Wolff-Parkinson-White syndrome or a similar heart electrical pathway condition that has not been fully corrected
• People with a history of certain heart rhythm problems (other than minor irregularities not linked to heart disease) within the 12 months before screening
• People with additional risk factors for a serious heart rhythm problem called Torsade de pointes — for example, heart failure, low potassium levels, or a family history of Long QT Syndrome
• People who have started a new form of mental health treatment within 12 weeks of enrolling, including electroconvulsive therapy (ECT) or ketamine-assisted therapy
• People with a moderate or severe alcohol or cannabis use disorder in the 12 months before enrolling
• People with an active substance use disorder involving illicit drugs (other than cannabis) or misused prescription drugs in the 12 months before enrolling
• People currently assessed as presenting a serious suicide risk, based on a psychiatric interview and clinical judgement (note: a past history of suicide attempts is not by itself an exclusion)
• People who are unable or unwilling to safely reduce or stop prohibited medications, or who need to use prohibited medications during the experimental sessions
• People who need to take medications during experimental sessions that could affect heart rhythm (specifically, those that may prolong the QT interval)
• People who have used unregulated Ecstasy (street MDMA) more than 10 times in the past 10 years, or at least once within 6 months of the first experimental session
• People currently enrolled in another clinical trial involving an experimental treatment, unless approved by the study doctor
• People with a current personality disorder or psychotic disorder
• People with a current eating disorder that involves compensatory behaviours
• People with current major depressive disorder that also involves psychotic features
• People with a history of, or current, primary psychotic disorder or bipolar disorder type 1
• People with a known sensitivity or allergy to any of the study drugs or their ingredients, where the study doctor believes this makes participation unsafe
• People currently involved in compensation or legal claims where a financial benefit would result from their fibromyalgia or psychiatric symptoms continuing
• People who lack social support or do not have a stable living situation
• People who have previously taken part in an MDMA clinical trial sponsored by MAPS
• Current employees (or their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V., or people in a personal relationship with the site investigator
• People with a chronic pain condition separate from fibromyalgia that they rate as more painful than their fibromyalgia
• People with severe anxiety or significant anxiety symptoms that would interfere with MRI brain scanning, such as panic disorder
• People who are currently a patient of the specific paired clinician enrolled in the study
• People who would present a serious risk of harm to others, as established through clinical interview and contact with their treating psychiatrist
• People with any other current issue that, in the study doctor's opinion, might interfere with safe or complete participation in the trial

Important: Always verify eligibility with the trial site directly before applying.