Improving life for patients with chronic fatigue syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The LIFT trial investigates the effects of Pyridostigmine and Low-Dose Naltrexone on individuals aged 18-65 diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and experiencing orthostatic intolerance. This double-blind, placebo-controlled study will enroll 160 participants who will be randomized into four groups to receive either the active medications or placebos. Dosages will be carefully adjusted based on individual tolerance, with weekly visits to monitor progress and make necessary changes. The goal is to assess the efficacy of these treatments in alleviating symptoms associated with ME/CFS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS
2. Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.
3. The onset of symptoms prior to December 2023.
4. Female participant is not pregnant and at least 1 of the following conditions apply:

   1. Not a woman of childbearing potential
   2. Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent.
5. Participant agrees and can adhere to the study requirements for the length of the study.
6. Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive.
7. Participant agrees not to participate in another interventional study while participating in the present study.
8. Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application.

Exclusion Criteria:

1. Pregnant, planning to become pregnant, or breastfeeding.
2. Any use of opioid medications within 30 days of screening.
3. Positive urine test for opioids
4. History of alcohol, opioid or other substance misuse
5. Participation in another interventional clinical trial in the last 30 days or planned during the trial period.
6. Allergy to medication components
7. Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.
8. Participant has diabetes mellitus (type 1 or 2).
9. 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.
10. 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)
11. Participant has an active malignancy or any other cancer.
12. Participant has initiated an exercise regimen within 4 weeks prior to randomization.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: David Systrom, MD — Massachusetts General Hospital
• Study coordinator: Research Coordinator
• Email: jsquires1@bwh.harvard.edu
• Phone: 617-525-6797

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Whole-body Cryotherapy for Fatigue in ME/CFS, Fibromyalgia, Long COVID

  This study tests whether brief, repeated exposure to extreme cold can help reduce fatigue and related symptoms in adults with ME/CFS, fibromyalgia, or Long COVID compared to healthy controls.

  Recruiting Oxford Brookes University · Oxford, Oxon · NCT07874217

• Magnetic resonance and rapid brain stimulation for Long COVID cognitive and mood symptoms

  This trial will test whether an accelerated outpatient magnetic brain stimulation (iTBS) can help reduce brain fog, depression, and anxiety in adults with Long COVID.

  Recruiting Phase 2 University of New Mexico · Albuquerque, New Mexico · NCT06940609

• Effects of Osteopathic Manipulative Therapy on Long COVID symptoms

  This study is testing whether Osteopathic Manipulative Therapy can help people with Long COVID feel better by reducing their symptoms over eight weeks.

  Recruiting University of Louisville · Louisville, Kentucky · NCT06883513

• A platform for collecting health data on ME/CFS and Long Covid

  This study is trying to collect health information from adults with ME/CFS and Long Covid to help researchers better understand these conditions and improve future treatments.

  Recruiting Brain Inflammation Collaborative · Delafield, Wisconsin · NCT04806620

• Fatigue Investigation Using Digital Outcomes

  This study tests whether digital monitoring with a smartphone app and wearables can track fatigue in people with MS or long COVID, compared with healthy volunteers.

  Recruiting at 6 sites University of Zurich · Basel, Basel and 5 other locations · NCT07783074

• Biomarker study to understand Long COVID using VIPER

  This study tests biomarkers in people with Long COVID and those who recovered from COVID-19 to see how they can diagnose and track the condition over time.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07770022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.