Naltrexone for Vasculitis

(LoDoNaVasc Trial)

Not currently recruiting at 6 trial locations

Overseen By Carol 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 Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if low-dose naltrexone can improve the quality of life for people with vasculitis, a condition characterized by inflamed blood vessels. Naltrexone, already used for other conditions, might alleviate pain and enhance life quality at a lower dose. Participants will receive either naltrexone or a placebo for six weeks to compare effects. This trial may suit those with stable vasculitis in remission or with very low disease activity, who have not changed their medication in the last 12 weeks. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-dose naltrexone is generally well-tolerated by individuals with conditions such as fibromyalgia, Crohn's disease, and multiple sclerosis. These studies suggest it is safe to use. The FDA has already approved naltrexone for treating alcoholism, which provides some confidence about its overall safety. However, when used at lower doses for other conditions, such as pain management, it is considered "off-label," meaning it is used in a way not originally approved. Although specific safety results for its use in vasculitis are not yet available, ongoing studies aim to gather more information. Participants in past studies of low-dose naltrexone have generally reported few unwanted side effects. This suggests the treatment might be well-tolerated, but more research in different conditions like vasculitis is needed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for vasculitis?

Unlike the standard treatments for vasculitis, which typically involve corticosteroids and immunosuppressants to dampen the immune system, Naltrexone Hydrochloride offers a novel approach. This treatment is unique because it works by modulating the body's opioid receptors, which may help to regulate the immune response more precisely. Researchers are excited about this because it could potentially reduce inflammation with fewer side effects than traditional therapies, offering a safer and more targeted treatment option for patients.

What evidence suggests that naltrexone might be an effective treatment for vasculitis?

Research has shown that low-dose naltrexone, which participants in this trial may receive, might improve the quality of life for individuals with conditions like fibromyalgia, Crohn's disease, and multiple sclerosis. These studies suggest that the drug can be safe and effective at lower doses than those approved for treating alcoholism. In these conditions, patients often reported less pain and better overall health. Although no published data exists yet for vasculitis, the drug's past success in similar conditions is promising. The exact mechanism remains unclear, but it is believed to interact with the body's opioid receptors, potentially managing pain and inflammation. ^{1 2 4 6 7}

Who Is on the Research Team?

Peter A Merkel, MD, MPH

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Naltrexone Hydrochloride Experimental Treatment 1 Intervention

Naltrexone hydrochloride for oral use, 4.5 mg per capsule, taken once a day for 6 weeks.

Group II: Placebo Comparator Placebo Group 1 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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03482479

Low Dose Naltrexone to Improve Physical Health in ... 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 ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20438025

Low Dose Naltrexone to Improve Physical Health in ... 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 ...

3. ldnresearchtrust.org ldnresearchtrust.org/pipeline-drugs-vasculitis-0

Pipeline Drugs for Vasculitis The trial is ongoing, with no published outcomes to date. Low-dose naltrexone: The opioid receptor antagonist naltrexone is being ...

4. rheumatologyadvisor.com rheumatologyadvisor.com/features/pipeline-drugs-for-vasculitis/

Pipeline Drugs for Vasculitis The trial is ongoing, with no published outcomes to date. Low-dose naltrexone: The opioid receptor antagonist naltrexone is being ...

5. ldnresearchtrust.org ldnresearchtrust.org/pipeline-drugs-vasculitis

Pipeline Drugs for Vasculitis The trial is ongoing, with no published outcomes to date. Low-dose naltrexone: The phase 2 LoDoNaVasc study is also exploring the potential of ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT03482479

Low Dose Naltrexone to Improve Physical Health in Patients ... 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 ...

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT03482479

Low Dose Naltrexone to Improve Physical Health in Patients ... The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among ...