Research Facility: Neuroinflammation, Pain, and Fatigue Laboratory at UAB
Director: Jarred Younger
Objective: To explore the potential benefits of Low Dose Naltrexone (LDN) in treating fatigue symptoms in individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME-CFS).
Background on Low-Dose Naltrexone (LDN)
Usual Applications: Traditionally used in higher doses for different medical conditions, including Crohn's disease, multiple sclerosis, depression, and fibromyalgia.
Dose in Study: Around 4.5 milligrams per day.
Anecdotal Evidence: Mixed reviews from individuals on the internet, with some reporting relief from fatigue and others not experiencing any change.
Study Design and Eligibility
Type of Study: Pilot trial, serving as a preliminary investigation to gauge whether further research in this area is warranted.
Duration: Approximately seven months, starting in January 2017 with a goal to conclude by the end of summer 2017.
Eligibility Criteria:
Proximity to Birmingham, Alabama for monthly lab visits.
Not pregnant.
Not taking opioid medications.
No major medical comorbidities such as heart disease or cancer.
Predominantly experiencing fatigue rather than pain.
Participant Experience
Number of Participants: 30 women.
Process:
Monthly Visits: Involving blood draws and receiving capsules to take nightly.
Daily Questionnaire: Taking about a minute to complete each day.
Blind Trial Structure: Participants would not know if they were receiving LDN or a placebo at any given time, but guaranteed to receive LDN at some point during the trial.
Objective and Hypotheses
Primary Question: Does LDN directly alleviate fatigue, or are potential benefits indirectly achieved through improved sleep from reduced pain?
Outcome Interest: Understanding whether LDN could be a viable treatment option for fatigue symptoms in ME/CFS patients based on scientific evidence, moving beyond mixed anecdotal reports.
Next Steps and Community Engagement
Larger Study: If the pilot study yields promising results, a larger study with a more diverse participant base would be pursued.
Participant Feedback: At the end of the study, participants would be informed of the periods they received LDN to understand its effects on their symptoms.
Community Anticipation: The study came to fruition after a long period of community requests and overcoming regulatory hurdles, indicating a high level of interest and anticipation from the community.
Participation and Compensation: Interested individuals were encouraged to reach out for screening through links provided in the video description, with participants being compensated for their involvement.
Conclusion
Researcher's Anticipation: Jarred Younger expressed eagerness to discover if LDN could be a solution for fatigue in ME/CFS patients and appreciated the community's willingness to participate.
Study Progress: As of the video release, the study was set to commence, aligning with the release date of the video in January 2017.
Contact for the Study: Dr. Luke Parkitny would be overseeing the study, with further details available through links in the video description.