ME/CFS study: Pyridostigmine vs Low-Dose Naltrexone
Official title LIFT: Life Improvement Trial
ClinicalTrials.gov ID: NCT06366724
What this study is testing
What is Pyridostigmine?
This is an investigational medicine being studied to see if it helps with symptoms of ME/CFS and orthostatic intolerance. It is designed to help nerve signals pass more easily between nerves and muscles by blocking an enzyme that breaks down a key chemical messenger.
Also referred to as Mestinon.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if these medicines help reduce symptoms in people with ME/CFS or Long COVID who have orthostatic intolerance. It compares the medicines to a placebo to find out if they make a difference.
- Who it's for
- Adults aged 18‑70 who meet Canadian criteria for ME/CFS or Long COVID and have orthostatic intolerance.
- What's involved
- Participants will receive either the medicines or a placebo, with doses adjusted weekly. They will have three in‑person visits, four virtual check‑ins, two exercise tests, and give blood and urine samples. Questionnaires will be filled out online.
- Time commitment
- The study lasts about three months, with three in‑person visits and four virtual visits during that time.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of...
- Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.
- The onset of symptoms prior to December 2023.
- Not a woman of childbearing potential
- Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent.
You likely can't join if
- 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 treatment clinical trial in the last 30 days or planned during the trial period.
- Allergy to medication components
See the full eligibility 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.
- 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 treatment study while participating in the present study.
- Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application.
- 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 treatment 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...
- Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis...
- Participant has an active malignancy or any other cancer.
- Participant has initiated an exercise regimen within 4 weeks prior to randomization.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.