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Opioid Antagonist

Naltrexone for Vasculitis (LoDoNaVasc Trial)

Phase 2
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 18 years or older
Patients must meet all criteria for diagnosis of giant cell arteritis (GCA), Takayasu's arteritis (TAK), polyarteritis nodosa (PAN), granulomatosis with polyangiitis (GPA, Wegener's), microscopic polyangiitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA) as used for the VCRC longitudinal studies
Must not have
Change in vasculitis activity in the past 12 weeks, as defined by a change in Physician Global Assessment greater than 1
Schizophrenia or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial is testing a drug called naltrexone to see if it can improve quality of life for people with vasculitis. Naltrexone is a drug that is approved for treating alcoholism, but is being used “off-label” to treat pain. There have been a few studies done on the drug in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest the drug is effective and safe. This trial is a pilot study, which means it is small, and has a placebo group to compare the results to.

Who is the study for?
This trial is for adults over 18 with certain types of vasculitis (like Giant Cell Arteritis or Wegener's Granulomatosis) who are in remission or have low disease activity. Participants should not have changed their medications for pain, fatigue, or mood in the last 12 weeks and must be willing to follow the study procedures.
What is being tested?
The trial tests if a low dose of Naltrexone can improve life quality in vasculitis patients compared to a placebo. It's an FDA-approved drug for alcoholism used off-label for pain relief. The study includes regular check-ins and compares self-reported health outcomes.
What are the potential side effects?
While specific side effects aren't listed here, Naltrexone at higher doses is known to cause nausea, headache, dizziness, anxiety, tiredness, and trouble sleeping. Low doses as used in this trial may result in milder versions of these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with a specific type of vasculitis.
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My vasculitis has been inactive or very mild for at least 3 months.
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I haven't changed my medications for pain, fatigue, or mood in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My vasculitis has worsened or improved significantly in the last 3 months.
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I have been diagnosed with schizophrenia or bipolar disorder.
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My depression or anxiety is not well-managed, with a high score on a health questionnaire.
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I have liver cirrhosis.
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My kidney function is significantly impaired.
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I am currently using opioid medication.
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I have not had any major health issues or surgeries in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinical Global Impression of Improvement (CGI-I)
Clinical Global Impression of Severity (CGI-S)
PROMIS Global Physical Health
+2 more

Side effects data

From 2014 Phase 3 trial • 317 Patients • NCT01392300
2%
Epilepsy
1%
Peipheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
Double-blind Placebo Comparator
OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naltrexone HydrochlorideExperimental Treatment1 Intervention
Naltrexone hydrochloride for oral use, 4.5 mg per capsule, taken once a day for 6 weeks.
Group II: Placebo ComparatorPlacebo Group1 Intervention
Placebo to match naltrexone for oral use to be taken once a day for 6 weeks.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,727,012 Total Patients Enrolled
Peter A Merkel, MD, MPHStudy DirectorUniversity of Pennsylvania
9 Previous Clinical Trials
2,166 Total Patients Enrolled

Media Library

Naltrexone Hydrochloride (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03482479 — Phase 2
Wegener's Granulomatosis Research Study Groups: Naltrexone Hydrochloride, Placebo Comparator
Wegener's Granulomatosis Clinical Trial 2023: Naltrexone Hydrochloride Highlights & Side Effects. Trial Name: NCT03482479 — Phase 2
Naltrexone Hydrochloride (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03482479 — Phase 2
~0 spots leftby Dec 2024
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