Improving life for patients with chronic fatigue syndrome
LIFT: Life Improvement Trial
This study is testing if two medications can help people aged 18-65 with chronic fatigue syndrome feel better and manage their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06366724 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who meet the Canadian consensus criteria for ME/CFS and have orthostatic intolerance.
Not a fit: Patients who do not meet the diagnostic criteria for ME/CFS or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide new treatment options for patients suffering from ME/CFS, potentially improving their quality of life.
How similar studies have performed: While there have been studies exploring treatments for ME/CFS, the specific combination of Pyridostigmine and Low-Dose Naltrexone in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.