Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

Condition
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15260

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84112

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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, Churg-Strauss), as used for the VCRC longitudinal studies
  • 1. Arteriographic abnormality
  • 2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
  • 3. Mononeuropathy or polyneuropathy ii. Minor criteria (not explained by other causes)
  • 1. Weight loss \> 4 kg 2. Livedo reticularis, cutaneous ulcerations, or skin nodules 3. Testicular pain or tenderness 4. Myalgias 5. Diastolic blood pressure \>90mm Hg 6. Elevated BUN or serum creatinine levels 7. Ischemic abdominal pain iii. Isolated cutaneous polyarteritis nodosa
  • 1. Biopsy-proven cutaneous PAN
  • 2. Baseline normalized score on PROMIS Global Physical Health of 40 or lower.
  • 3. Vasculitis in remission or very low disease activity, as defined by Physician Global Assessment 0-1 for at least 12 weeks
  • 4. Stable immunosuppressive therapy (including prednisone) related to vasculitis for at least 12 weeks
  • 5. No change in medications in the past 12 weeks made with the expectation of improving pain, fatigue, or mood
  • 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
  • 7. Age of 18 years or older
  • 8. Willingness and ability to comply with treatment and follow-up procedures, including receipt of weekly phone calls from the study coordinator
  • 9. Willingness and ability to provide informed consent -
  • 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. Use of another investigational agent as part of a clinical trial within 30 days of enrollment
  • 3. Current use of any opioid agonist including tramadol or suboxone
  • 4. Change in vasculitis activity in the past 12 weeks, as defined by a change in Physician Global Assessment greater than 1
  • 5. Baseline normalized score more than 40 on PROMIS Global Physical Health
  • 6. New major medical problem or surgery in past 12 weeks
  • 7. Pregnancy or breastfeeding
  • 8. Inability to provide informed consent or comply with study procedures
  • 9. Schizophrenia or bipolar disorder
  • 10. Poorly controlled depression or anxiety, as defined by a score of ≥ 20 on PHQ-9
  • 11. Liver cirrhosis
  • 12. Significant kidney disease, defined as glomerular filtration rate \<30ml/min

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

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

Study Record Dates

2024-12-31