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Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

NCT03482479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Peter A Merkel, MD, MPH · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482479 on ClinicalTrials.gov