Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (NCT03482479) | Clinical Trial Compass
CompletedPhase 2
Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
United States60 participantsStarted 2019-02-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Arteriographic abnormality
✓. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
✓. Mononeuropathy or polyneuropathy ii. Minor criteria (not explained by other causes)
✓. Biopsy-proven cutaneous PAN
✓. Baseline normalized score on PROMIS Global Physical Health of 40 or lower.
✓. Vasculitis in remission or very low disease activity, as defined by Physician Global Assessment 0-1 for at least 12 weeks
✓. Stable immunosuppressive therapy (including prednisone) related to vasculitis for at least 12 weeks
✓. No change in medications in the past 12 weeks made with the expectation of improving pain, fatigue, or mood
Exclusion criteria
✕. Change in any medication related to control of vasculitis, pain, fatigue, or mood within the past 12 weeks (medications taken as needed must be in a stable pattern per the patient's estimation)