Low-Dose Naltrexone For ME/CFS: Dose-Finding

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.

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