Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (LoDoNaVasc)
CURRENTLY ENROLLING: YES
The purpose of this study is to see whether a drug called naltrexone improves health-related quality of life in patients with vasculitis.
YES. The medication you need to take to participate in the study is low dose naltrexone (4.5 mg).
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. Naltrexone is a prescription drug approved for a different reason at a higher dose than the dose used in this study. However, “low-dose naltrexone” is widely used for a wide range of conditions associated with pain or fatigue. We hope to learn more about the impact of low-dose naltrexone on the symptoms caused by vasculitis.
- Patients must first have a diagnosis of the following types of vasculitis:
- Giant cell arteritis (GCA)
- Takayasu’s arteritis
- Polyarteritis nodosa (PAN)
- Granulomatosis with polyangiitis (GPA // Wegener’s)
- Microscopic polyangiitis (MPA)
- Eosinophilic granulomatosis with polyangiitis (EGPA // Churg-Strauss)
- Patients must also have a significantly low quality of life caused by some combination of pain, fatigue, poor physical health, and difficulty carrying out activities.
- Medication used to treat vasculitis, pain, and fatigue must be stable for 12 weeks before a patient can enroll in the study.
- Disease activity must also be in remission or have very low activity
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 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, 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 should take about 20 minutes to complete while the questionnaire at Week 3 and Week 9 should only take about 5 minutes to complete.