Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label"
to treat pain and improve quality of life at much lower doses than are used for the approved
indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's
disease, and multiple sclerosis) that suggest that this drug has benefit and is safe.
However, considering the extent of use in other conditions, and uncertainty about the
mechanism of action study is needed in a diverse set of diseases, including vasculitis.
The purpose of this clinical trial is to determine if low dose naltrexone is effective in
improving health-related quality of life (HRQoL) among patients with vasculitis. Although it
is a pilot study, a placebo-controlled component is used because of the prominent placebo
group effect seen in studies with self-reported subjective outcomes.