5564: Low Dose Naltrexone to Improve Physical Health in Patients with Vasculitis (LoDoNaVasc)

Status: Not Yet Recruiting

The purpose of this study is to see whether a drug called naltrexone improves health-related quality of life in patients with vasculitis. Naltrexone is a prescription drug approved for a different reason at a much higher dose than the dose used in this study. However, “low dose naltrexone” is widely used, without insurance coverage, for a wide range of conditions associated with pain or fatigue, and is particularly popular among patients with autoimmune diseases. The study doctors hope to learn more about the impact of low dose naltrexone on the symptoms you experience related to your vasculitis.

For Diseases

  • Giant cell arteritis
  • Takayasu’s arteritis
  • Polyarteritis nodosa
  • Granulomatosis with polyangiitis (Wegener’s)
  • Microscopic polyangiitis
  • Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)

Background

Vasculitis may cause pain, fatigue, problems with mood, difficulty sleeping, and difficulty with activities, resulting in a lower health-related quality of life for many patients. There are a few scientific studies in inflammatory conditions that suggest that low dose naltrexone may improve health-related quality of life. The study doctors hope to learn more about the impact of low dose naltrexone on the symptoms you experience caused by your vasculitis.

About this Study

60 participants with vasculitis will join this study (40 of these participants will have GPA, MPA, or EGPA). You will be randomized by a computer. You will take 6 weeks of low dose naltrexone (4.5 mg) and 6 weeks of placebo during a 12-week period. You will not know what you are taking and neither will your doctor. You will be asked to go to the study center to find out if you are eligible to participate. You will need to return to the study center at Week 6 and then again at Week 12/End of the Study.

While you are on the study, you will take one pill every day. You will be asked to keep a diary of taking the pill. You can choose to use a paper diary or an electronic diary. You will need to complete questionnaires at the start of the study, Week 3, Week 6, Week 9, and Week 12/End of Study. The questionnaires at the start of the study, at Week 6, and at Week 12/ End of Study will be done at the site. You can choose to complete the questionnaires at Week 3 and Week 9 on paper or electronically.

When you return to the study center at Week 6 and Week 12/End of Study, you will need to bring your pill bottle with you and any pills you did not take during this time. You will also need to bring your diary and questionnaires if you completed them on paper.

The questionnaires that you will complete during the course of the study will ask about your fatigue, mood, pain, and the activity level of your vasculitis. The questionnaires at the start of the study, Week 6, and Week 12/End of Study should take about 20 minutes to complete while the questionnaire at Week 3 and Week 9 should only take about 5 minutes to complete.

Target Enrollment

To be eligible to participate, patients must meet all of the following criteria in order to be eligible for enrollment:

  • You must have a diagnosis of any of the following:
    • Giant cell arteritis (GCA)
    • Takayasu’s arteritis (TAK)
    • Polyarteritis nodosa (PAN)
    • Granulomatosis with polyangiitis (GPA, Wegener’s)
    • Microscopic polyangiitis (MPA)
    • Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss)
  • You will need to complete a questionnaire at the study center
    • The score of the questionnaire will need to indicate that you have a low quality of life caused by some combination of pain, fatigue, poor physical health, and difficulty carrying out activities.
  • Your vasculitis will need to be in remission or have very low activity at time of enrollment. This does not mean that you have no symptoms, but rather that your doctor does not feel that inflammation is at a level where increase in immunosuppressive treatment is needed.
  • You will need to be on a stable dose of immunosuppressive therapy (including prednisone) for at least 12 weeks prior to joining the study
  • You cannot have had any change in medication in the past 12 weeks of joining that study made with the expectation of improving pain, fatigue, or mood
  • You cannot have plans to change medication or a change in treatment for your vasculitis that will likely impact your pain, fatigue, mood, or vasculitis activity while you participate in this study
  • You need to be at least 18 years old
  • You must be willing and able to follow the treatment for this study and the instructions that are provided to you by the study staff
    • This may include receiving weekly phone calls from the study staff
  • You must be willing and able to provide informed consent to participate

You are not eligible to participate if:

  • You have taken an experimental drug within 30 days of joining this study
  • You currently use any opioid medications including morphine, oxycodone, hydrocodone, hydromorphone, codeine, methadone, suboxone, or tramadol
  • You have had a flare (even minor) of your vasculitis within the previous 12 weeks of joining this study
  • You have developed a new major medical problem or surgery in the past 12 weeks
  • You are pregnant or breastfeeding
  • You cannot provide informed consent or are not able to comply with the study procedures or instructions
  • You have been diagnosed with schizophrenia or bipolar disorder
  • You have poorly controlled depression or anxiety
  • You have been diagnosed with liver cirrhosis
  • You have significant kidney disease

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Pennsylvania - Not Yet Recruiting