NCT03482479

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Eosinophilic Granulomatosis With Polyangiitis (EGPA)
• Churg-Strauss Syndrome (CSS)
• Giant Cell Arteritis
• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Naltrexone Hydrochloride	Naltrexone Hydrochloride will be taken daily (dose 4.5 mg) for six weeks
OTHER	Placebo Comparator	A placebo tablet which matches the drug will be taken daily for 6 weeks.

Timeline

• Start date: 2019-02-04
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-03-29
• Last updated: 2026-01-22

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study