Apply to Trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

36 Participants Needed

Naltrexone for Vasculitis
(LoDoNaVasc Trial)

Recruiting at 2 trial locations

Overseen ByCarol McAlear, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must not be taking: Opioid agonists

Disqualifiers: Schizophrenia, Bipolar, Depression, Anxiety, others

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that your current medications related to vasculitis, pain, fatigue, or mood have been stable for at least 12 weeks before joining. You should not plan to change these medications during the trial.

Is naltrexone generally safe for humans?

Naltrexone, used in various forms and doses, has been studied for safety in different conditions. Injectable extended-release naltrexone has potential liver-related side effects, especially in patients with liver conditions like hepatitis C. Low-dose oral naltrexone has been reported as safe, with minor side effects like dry skin, insomnia, diarrhea, and headaches in some cases.¹ ² ³ ⁴ ⁵

How is the drug naltrexone unique in treating vasculitis?

Naltrexone is unique because it is an opioid antagonist that, in low doses, can modulate the immune system, potentially offering a novel approach to treating autoimmune conditions like vasculitis without the risk of immunosuppression associated with other treatments.³ ⁴ ⁶ ⁷ ⁸

What is the purpose of this trial?

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.

Research Team

Peter A Merkel, MD, MPH

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

Willingness and ability to comply with treatment and follow-up procedures, including receipt of weekly phone calls from the study coordinator

I have been diagnosed with a specific type of vasculitis.

My vasculitis has been inactive or very mild for at least 3 months.

See 5 more

Exclusion Criteria

My vasculitis has worsened or improved significantly in the last 3 months.

Your physical health score is higher than 40 on the PROMIS test before starting the study.

I haven't changed my medication for vasculitis, pain, fatigue, or mood in the last 3 months.

See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose naltrexone or placebo for 6 weeks, followed by a crossover to the alternate treatment for another 6 weeks

12 weeks

Visits every 3 weeks for outcome measures

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Naltrexone Hydrochloride
Placebo Comparator

Trial Overview 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.

Participant Groups

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.

Naltrexone Hydrochloride is already approved in United States, European Union for the following indications:

Approved in United States as ReVia for:

Alcohol use disorder
Opioid use disorder

Approved in United States as Vivitrol for:

Alcohol use disorder
Opioid use disorder

Approved in United States as Depade for:

Alcohol use disorder
Opioid use disorder

Approved in European Union as Naltrexone for:

Alcohol dependence
Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

A study involving 250 opioid-dependent patients, many of whom had chronic hepatitis C virus (HCV) and HIV, found that intramuscular extended-release naltrexone (XR-NTX) did not significantly increase liver enzyme levels compared to a placebo, indicating its safety in this population.

Even though some patients experienced elevated liver enzymes, these levels improved over time, and no specific symptoms were linked to these elevations, suggesting that XR-NTX can be safely administered to patients with mild to moderate chronic HCV and/or HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection.Mitchell, MC., Memisoglu, A., Silverman, BL.[2019]

In a 1-year open-label extension study involving 114 patients, injectable extended-release naltrexone (XR-NTX) demonstrated long-term efficacy, with 50.9% of participants remaining abstinent from opioids throughout the study.

The treatment was generally safe, with only 21.1% of patients reporting adverse events and no severe adverse events noted, although 16.7% experienced elevated liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy].Krupitsky, EM., Nunes, EV., Ling, W., et al.[2016]

In a study involving 15 hemodialysis patients, naltrexone significantly reduced severe pruritus (itching) from a median score of 9.9 to 1.0, indicating its potential effectiveness in treating this condition.

Naltrexone also decreased elevated plasma histamine levels, which are associated with itching, suggesting that its mechanism of action may involve modulating histamine release in addition to its role as an opioid antagonist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised crossover trial of naltrexone in uraemic pruritus.Peer, G., Kivity, S., Agami, O., et al.[2022]