COMPLETED

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

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Conditions

Eosinophilic Granulomatosis With Polyangiitis (EGPA)Churg-Strauss Syndrome (CSS)Giant Cell ArteritisGranulomatosis With PolyangiitisMicroscopic PolyangiitisPolyarteritis NodosaTakayasu Arteritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

Quick Facts

Study Start:2019-02-04
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03482479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Arteriographic abnormality
  2. 2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
  3. 3. Mononeuropathy or polyneuropathy ii. Minor criteria (not explained by other causes)
  4. 1. Biopsy-proven cutaneous PAN
  5. 2. Baseline normalized score on PROMIS Global Physical Health of 40 or lower.
  6. 3. Vasculitis in remission or very low disease activity, as defined by Physician Global Assessment 0-1 for at least 12 weeks
  7. 4. Stable immunosuppressive therapy (including prednisone) related to vasculitis for at least 12 weeks
  8. 5. No change in medications in the past 12 weeks made with the expectation of improving pain, fatigue, or mood
  9. 6. No plan to change medication or a non-pharmacologic treatment regimen likely to affect pain, fatigue, mood, or vasculitis activity during the next 12 weeks
  10. 7. Age of 18 years or older
  11. 8. Willingness and ability to comply with treatment and follow-up procedures, including receipt of weekly phone calls from the study coordinator
  12. 9. Willingness and ability to provide informed consent -
  1. 1. Change in any medication related to control of vasculitis, pain, fatigue, or mood within the past 12 weeks (medications taken as needed must be in a stable pattern per the patient's estimation)
  2. 2. Use of another investigational agent as part of a clinical trial within 30 days of enrollment
  3. 3. Current use of any opioid agonist including tramadol or suboxone
  4. 4. Change in vasculitis activity in the past 12 weeks, as defined by a change in Physician Global Assessment greater than 1
  5. 5. Baseline normalized score more than 40 on PROMIS Global Physical Health
  6. 6. New major medical problem or surgery in past 12 weeks
  7. 7. Pregnancy or breastfeeding
  8. 8. Inability to provide informed consent or comply with study procedures
  9. 9. Schizophrenia or bipolar disorder
  10. 10. Poorly controlled depression or anxiety, as defined by a score of ≥ 20 on PHQ-9
  11. 11. Liver cirrhosis
  12. 12. Significant kidney disease, defined as glomerular filtration rate \<30ml/min

Contacts and Locations

Principal Investigator

Peter A Merkel, MD, MPH
STUDY_DIRECTOR
University of Pennsylvania

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-04
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-02-04
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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