Boston, MANCT06366724Now EnrollingIRB Ready

ME/CFS Clinical Trial in Boston, MA

Access cutting-edge me/cfs treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Brigham and Women's Hospital

Quick Self-Assessment

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Expert Care in Boston

Access me/cfs specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related me/cfs treatment provided free

Apply for This Boston Location

Check if you qualify for this me/cfs clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This ME/CFS Study in Boston

The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI. This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily. The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial. The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete. The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion Criteria

Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS
Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.
The onset of symptoms prior to December 2023.
Female participant is not pregnant and at least 1 of the following conditions apply:
Not a woman of childbearing potential
Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent.
Participant agrees and can adhere to the study requirements for the length of the study.
Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive.
Participant agrees not to participate in another interventional study while participating in the present study.
Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application.

Exclusion Criteria

Pregnant, planning to become pregnant, or breastfeeding.
Any use of opioid medications within 30 days of screening.
Positive urine test for opioids
History of alcohol, opioid or other substance misuse
Participation in another interventional clinical trial in the last 30 days or planned during the trial period.
Allergy to medication components
Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.
Participant has diabetes mellitus (type 1 or 2).
Participant has undergone an inpatient hospitalization within the 30 days prior to the randomization or has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments, in the opinion of the investigator.
Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis, pulmonary fibrosis, and lung cancers) and/or cardiac disease (medical history or current clinical findings)
Participant has an active malignancy or any other cancer.
Participant has initiated an exercise regimen within 4 weeks prior to randomization.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06366724) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

ME/CFS Treatment Options in Boston, MA

If you're searching for me/cfs treatment options in Boston, MA, this clinical trial (NCT06366724) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced me/cfs specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all me/cfs clinical trials near you to find additional studies recruiting in your area.

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