Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Conditions
Keywords
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, ME/CFS
Brief 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.
Detailed 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 from Alabama, 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 baseline for determining treatment effects. After the 30-day baseline, the treatment stage will begin. After the baseline period, participants will receive LDN capsules at one of four doses: 1.5mg/day, 3.0mg/day, 4.5mg/day, and/or 6.0mg/day in a blinded fashion. Capsules are sent by FedEx every two months and are taken daily without breaks. Participants and research assistants dealing with participants are blinded to the dose schedule. Data on adherence to the treatment protocol is monitored using smart pill dispensers. This treatment stage is the longest, lasting 8 months, with participants continuing to complete weekly outcome measures. After eight months of study capsules, participants will enter a one-month endline phase where no medications are taken. Outcomes will still be completed once per week.
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.
Sponsors
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is single-blind, participants will not know when they received 1.5mg/day, 3.0mg/day, 4.5mg/day, or 6.0mg/day low-dose naltrexone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Fatigue Short Form 7a | 10 months | This will be measured using weekly surveys. |
Countries
United States
Contacts
CONTACTJarred Younger, PhD
PRINCIPAL_INVESTIGATORJarred Younger, PhD
University of Alabama at Birmingham
Outcome results
None listed