Actively Recruiting
LIFT: Life Improvement Trial for ME/CFS and Long COVID Evaluating Pyridostigmine and Low-Dose Naltrexone
Led by Brigham and Women's Hospital · Updated on 2025-10-22
160
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
O
Open Medicine Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in adults aged 18 to 70 who have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) meeting Canadian consensus criteria and also experience Orthostatic Intolerance (OI). The study also includes people with Long COVID if they meet the same criteria. This double-blind, placebo-controlled trial aims to better understand and improve treatments for these conditions. Participants will be randomly assigned to one of four groups: Pyridostigmine with LDN, Pyridostigmine with placebo, LDN with placebo, or placebo with placebo. Pyridostigmine is taken as a liquid three times daily, gradually increasing from 20mg to 60mg per dose, while LDN is taken once daily, increasing from 1.5mg to 4.5mg. The study includes a plan to reduce doses if participants experience side effects, with adjustments made during weekly visits. The study lasts about three months and involves three in-person visits and four virtual visits. Participants will complete two submaximal cardiopulmonary exercise tests, questionnaires online, and provide blood and urine samples. Researchers will measure functional capacity and several physiologic responses such as oxygen uptake and heart rate recovery. Safety and symptom monitoring will be ongoing throughout the trial period, which is expected to take two years to complete.
CONDITIONS
Brief Title
LIFT: Life Improvement Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet National Academy of Medicine and Canadian Consensus Criteria for ME/CFS with orthostatic intolerance
- Aged 18 to 70 years at screening
- Symptoms started before December 2023
- Female participants must not be pregnant and either not of childbearing potential or agree to contraceptive guidance
- Agree and able to follow study requirements for the full study duration
- Body mass index between 17 and 40 kg/m2
- Agree not to participate in another interventional study during this trial
- Have a functioning smartphone to use the DANA Brain Vital Mobile Application
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding
- Use of opioid medications within 30 days before screening
- Positive urine test for opioids
- History of alcohol, opioid, or other substance misuse
- Participation in another interventional trial within 30 days or planned during this study
- Allergy to any medication components
- Any condition making participation unsuitable as judged by the investigator
- Diagnosis of diabetes mellitus (type 1 or 2)
- Hospitalization within 30 days before randomization or planned hospitalization/surgery during the trial affecting assessments
- Significant respiratory or cardiac disease
- Active cancer or malignancy
- Started an exercise regimen within 4 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants receive Pyridostigmine and/or Low-Dose Naltrexone or placebo as liquid suspensions with dose escalation over time.
Weekly visits for up to 13 weeks
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here