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 States, Canada60 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)
. Use of another investigational agent as part of a clinical trial within 30 days of enrollment
. Current use of any opioid agonist including tramadol or suboxone
. Change in vasculitis activity in the past 12 weeks, as defined by a change in Physician Global Assessment greater than 1
. Baseline normalized score more than 40 on PROMIS Global Physical Health
. New major medical problem or surgery in past 12 weeks
. Pregnancy or breastfeeding
. Inability to provide informed consent or comply with study procedures