Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (LoDoNaVasc)
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|ClinicalTrials.gov Identifier: NCT03482479|
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : October 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Granulomatosis With Polyangiitis (EGPA) Churg-Strauss Syndrome (CSS) Giant Cell Arteritis Granulomatosis With Polyangiitis Microscopic Polyangiitis Polyarteritis Nodosa Takayasu Arteritis||Drug: Naltrexone Hydrochloride Other: Placebo Comparator||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis|
|Estimated Study Start Date :||December 30, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: Naltrexone Hydrochloride
Naltrexone hydrochloride for oral use, 4.5 mg per capsule, taken once a day for 6 weeks.
Other: Placebo Comparator
A placebo tablet which matches the drug will be taken daily for 6 weeks.
Placebo Comparator: Placebo Comparator
Placebo to match naltrexone for oral use to be taken once a day for 6 weeks.
Drug: Naltrexone Hydrochloride
Naltrexone Hydrochloride will be taken daily (dose 4.5 mg) for six weeks
- PROMIS Global Physical Health [ Time Frame: Week 12. ]Questionnaire about improved health related quality of life to a greater extent than placebo.
- PROMIS Global Physical Health [ Time Frame: 9 weeks ]Questionnaire about improved health related quality of life to a greater extent than placebo.
- SF-36 (physical component subscore) [ Time Frame: 12 weeks ]Health related quality of life measured by a questionnaire.
- PROMIS Questionnaires [ Time Frame: 12 weeks ]Questions will ask about anxiety, depression, and sleep disturbance on the PROMIS short form, PROMIS Global Mental Health, and on PROMIS-CAT will ask about physical function, fatigue, satisfaction with social roles, and pain interference, as well in the pain intensity item.
- Clinical Global Impression of Severity (CGI-S) [ Time Frame: 12 weeks ]7-point scale of patients' self-reporting of severity during the study.
- Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 12 weeks ]7-point scale of patients' self-reporting of severity during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482479
|Contact: Carol McAlear, MAemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Peter Merkel, MD, MPH 215-614-4401|
|Study Director:||Peter A Merkel, MD, MPH||University of Pennsylvania|