Low-dose Naltrexone (LDN) for the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Dose-Finding
University of Alabama at Birmingham
Summary
This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama.
Description
This study uses a remote design where individuals can participate from anywhere in the state of Alabama. Study medications will be received by mail. All participants must meet ME-ICC criteria. This study will be tested on participants recruited nationwide, with a total of 75 participants enrolled for the entire study. Participation will last 10 months. The first stage of the study is the baseline phase. During this time, participants will complete weekly outcome measurements but will not take any medications. The baseline stage will last for 30 days. This period is used to calculate a stable…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Between ages of 18 and 65 * Living in Alabama * Meets ME-ICC criteria Exclusion Criteria: * Abnormal hepatic function * Abnormal renal function * Abnormal complete blood count * Evidence of active or chronic systemic infection * A1C \> 9.0% * Current opioid analgesic use * Pregnant or plans to become pregnant during the study participation period * Auto-immune disorder * Enrolled in other experimental treatment study
Interventions
- DrugLow-Dose Naltrexone, 1.5mg
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
- DrugLow-Dose Naltrexone, 3.0mg
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
- DrugLow-Dose Naltrexone, 4.5mg
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
- DrugLow-Dose Naltrexone, 6.0mg
Low-Dose Naltrexone (LDN) is not a commercially available drug and will be compounded for this study. LDN will be taken orally, up to once per day.
Location
- University of Alabama at BirminghamBirmingham, Alabama