The Life Improvement Trial (LIFT) aims to investigate two drugs, separately and in combination, Pyridostigmine (commonly known as Mestinon) and Low-Dose Naltrexone (LDN), for efficacy and to research the difference between responders and non-responders.
The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.
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 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance. Both drugs may be anti-inflammatory, LDN through the blockage of toll-like receptors, and Pyridostigmine through its cholinergic effects.
This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible arms: 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 OMF StudyME Registry and anticipate the entire trial will take two (2) years to complete.
OMF is a non-profit 501(c)(3) organization
(EIN# 26-4712664). All donations are tax-deductible to the extent allowed by law.
Open Medicine Foundation®
29302 Laro Drive, Agoura Hills, CA 91301 USA
Phone: 650-242-8669
info@omf.ngo
Copyright © 2024 Open Medicine Foundation. All Rights Reserved.
What are the advantages of giving from your Donor Advised Fund (DAF)?
How do I make a donation through my DAF?
Just click on the DAF widget below. It is simple and convenient to find your fund among the over 900 funds in our system.
Still can’t find your fund?
Gifting of Stock
Broker: Schwab
DTC #: 0164
Account #: 47083887
Account Registered as:
Open Medicine Foundation
29302 Laro Drive
Agoura Hills, CA 91301
Please speak to your personal tax advisor and then email or call OMF at 650-242-8669 to notify us of your donation or with any questions.