Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Churg-Strauss Syndrome (CSS)
- Eosinophilic Granulomatosis With Polyangiitis (EGPA)
- Giant Cell Arteritis
- Granulomatosis With Polyangiitis
- Microscopic Polyangiitis
- Polyarteritis Nodosa
- Takayasu Arteritis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 L...
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
Tracking Information
- NCT #
- NCT03482479
- Collaborators
- Not Provided
- Investigators
- Study Director: Peter A Merkel, MD, MPH University of Pennsylvania
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