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.
This is a multi-center, randomized, double-blind, cross-over, placebo-controlled trial to
evaluate the efficacy of low-dose naltrexone (LDN) 4.5 mg nightly in improving self-reported
physical health in patients with vasculitis.
At study enrollment, each patient will be randomized to receive either LDN for 6 weeks
followed by oral placebo for 6 weeks, or placebo for 6 weeks followed by LDN for 6 weeks. The
primary outcome measure and some secondary outcome measures are patient-reported and will be
recorded every 3 weeks, or every 6 weeks
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS), Giant Cell Arteritis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu Arteritis
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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