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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Naltrexone Hydrochloride will be taken daily (dose 4.5 mg) for six weeks
A placebo tablet which matches the drug will be taken daily for 6 weeks.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
St. Joseph's Healthcare
Hamilton, Ontario, Canada
PROMIS Global Physical Health
Questionnaire about improved health related quality of life to a greater extent than placebo.
Time frame: Week 12.
PROMIS Global Physical Health
Questionnaire about improved health related quality of life to a greater extent than placebo.
Time frame: 9 weeks
SF-36 (physical component subscore)
Health related quality of life measured by a questionnaire.
Time frame: 12 weeks
PROMIS Questionnaires
Questions will ask about anxiety, depression, and sleep disturbance on the PROMIS short form, PROMIS Global Mental Health, and on PROMIS-CAT will ask about physical function, fatigue, satisfaction with social roles, and pain interference, as well in the pain intensity item.
Time frame: 12 weeks
Clinical Global Impression of Severity (CGI-S)
7-point scale of patients' self-reporting of severity during the study.
Time frame: 12 weeks
Clinical Global Impression of Improvement (CGI-I)
7-point scale of patients' self-reporting of severity during the study.
Time frame: 12 weeks
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