Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (LoDoNaVasc)

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    36
  • sponsor
    University of Pennsylvania
Updated on 25 March 2022
claudication
angiography
remission
ct angiography
cavities
tenderness
prednisone
immunosuppressive agents
fatigue
immunosuppressive therapy
chest radiograph
immunosuppressants
immunosuppression
vasculitis
glomerulonephritis
asthma
naltrexone
crohn's disease
localized pain
intermittent claudication
diastolic blood pressure
giant cell arteritis
polyarteritis nodosa
takayasu's arteritis
wegener's granulomatosis
churg-strauss syndrome
arteritis
enzyme immunoassay
granulomatosis
anca
arteriosclerosis
granulomatous inflammation
polyarteritis
myalgias
nasal discharge
anti-neutrophil cytoplasmic antibody
necrotizing glomerulonephritis
necrotizing arteritis
livedo reticularis
arteriogram
eosinophilic granulomatosis

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.

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

Details
Condition Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS), Giant Cell Arteritis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu Arteritis
Treatment Placebo Comparator, Naltrexone Hydrochloride
Clinical Study IdentifierNCT03482479
SponsorUniversity of Pennsylvania
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must meet all of the following criteria in order to be eligible for
enrollment
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
Giant cell arteritis: According to the American College of Rheumatology (ACR) criteria for classification of GCA, meeting at least 2 of the following 5 remaining criteria at the time of diagnosis of GCA: Age of disease onset >50 years (required) i. New onset or new type of localized pain in the head ii. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries) iii. ESR of >40 mm in the first hour by Westergren method iv. Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells v. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else
Takayasu's arteritis: According to an adaption of the American College of Rheumatology criteria, meeting at least 2 of the following 5 remaining criteria at the time of inclusion of TAK: Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography) (required) i. Age at disease onset ≤50 years ii. Claudication of extremities iii. Decreased brachial artery pulse (one or both arteries) iv. Blood pressure difference of >10mm Hg between the arms v. Bruit over subclavian arteritis or aorta
Polyarteritis nodosa: An adaption of the America College of Rheumatology criteria will be used for the diagnosis of PAN. At the time of inclusion, one major and one minor criteria or two major criteria or isolated cutaneous PAN must be met
Major criteria (not explained by other causes)
Arteriographic abnormality
Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
Mononeuropathy or polyneuropathy ii. Minor criteria (not explained by other causes)
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
Biopsy-proven cutaneous PAN
Granulomatosis with polyangiitis: Participants can be enrolled if two of the five modified American College of Rheumatology criteria are met: i. Nasal or oral inflammation: painful or painless oral ulcers or purulent or blood nasal discharge ii. Abnormal chest radiograph: nodules, fixed infiltrates, or cavities iii. Urinary sediment: microhematuria or red cell casts iv. Granulomatous inflammation on biopsy: granulomatous inflammation within the wall of an artery or in the perivascular area v. ANCA positivity by enzyme immunoassay for either PR3- or MPO-ANCA e. Microscopic polyangiitis: The following Chapel Hill Consensus Conference Definitions for MPA need to be met: i. Necrotizing vasculitis with few or no immune deposits affects small vessel (i.e., capillaries, venules, or arterioles) ii. Necrotizing arteritis involving small and medium-sized arteritis may be present iii. Necrotizing glomerulonephritis is very common iv. Pulmonary capillaritis often occurs
Eosinophilic granulomatosis with polyangiitis: An adaptation of the American College of Rheumatology criteria will be used for the diagnosis of EGPA. At the time of inclusion, four of the six items must have documented evidence: i. Asthma ii. Peak peripheral blood eosinophilia of >10% of total WBC iii. Peripheral neuropathy attributable to vasculitis iv. Transient pulmonary infiltrates on chest imaging studies v. Paranasal sinus abnormalities or nasal polyposis vi. Eosinophilic inflammation on tissue biopsy If patients have 4 of the above 6 criteria but lack clear-cut documentation of small vessel vasculitis, they are also eligible for enrollment
Baseline normalized score on PROMIS Global Physical Health of 40 or lower
Vasculitis in remission or very low disease activity, as defined by Physician Global Assessment 0-1 for at least 12 weeks
Stable immunosuppressive therapy (including prednisone) related to vasculitis for at least 12 weeks
No change in medications in the past 12 weeks made with the expectation of improving pain, fatigue, or mood
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
Age of 18 years or older
Willingness and ability to comply with treatment and follow-up procedures, including receipt of weekly phone calls from the study coordinator
Willingness and ability to provide informed consent -

Exclusion Criteria

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)
Use of another investigational agent as part of a clinical trial within 30 days of enrollment
Current use of any opioid agonist including tramadol or suboxone
Change in vasculitis activity in the past 12 weeks, as defined by a change in Physician Global Assessment greater than 1
Baseline normalized score more than 40 on PROMIS Global Physical Health
New major medical problem or surgery in past 12 weeks
Pregnancy or breastfeeding
Inability to provide informed consent or comply with study procedures
Schizophrenia or bipolar disorder
Poorly controlled depression or anxiety, as defined by a score of ≥ 20 on PHQ-9
Liver cirrhosis
Significant kidney disease, defined as glomerular filtration rate <30ml/min
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note