LIFT: Life Improvement Trial
- NCT ID
- NCT06366724
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 2
- Sponsor
- Brigham and Women's Hospital
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 160 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility 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.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Massachusetts, United States: 1
Sample of listed locations
- Brigham and Women's Hospital — Boston, Massachusetts, 02115, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- September 10, 2024
- Primary completion date
- September 1, 2026
- First posted
- April 16, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06366724
- Registry last updated
- October 22, 2025
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06366724 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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