Disulfiram for Rheumatoid Arthritis

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NF
Overseen ByNatalie Feland, MPH, BSN, RN
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether disulfiram, a drug typically used to treat alcohol addiction, can reduce inflammation and improve symptoms in individuals with rheumatoid arthritis (RA), particularly those who are overweight or obese. Researchers aim to assess its safety and effectiveness in lowering inflammation in the body and joints. Participants will receive either disulfiram or a placebo (a harmless pill with no active drug) alongside their regular RA medication. Individuals with RA who have active symptoms and are willing to abstain from alcohol during the study might be suitable candidates. The results could lead to larger studies focused on new treatments for RA. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have been on stable RA medication for at least 3 months before joining. Some medications, like metronidazole and warfarin, are not allowed during the trial.

Is there any evidence suggesting that disulfiram is likely to be safe for humans?

Research has shown that disulfiram, a drug commonly used to treat alcohol addiction, is being studied for its potential to reduce inflammation. Studies have found that disulfiram can decrease certain inflammatory processes, which might help with conditions like rheumatoid arthritis.

Regarding safety, real-world data has examined side effects linked to disulfiram. Results suggest that while disulfiram is generally well-tolerated, it can cause some side effects, such as tiredness or mild stomach issues. However, serious side effects are rare.

Since the FDA has approved disulfiram for other uses, some information about its safety is already known. This approval indicates it has passed strict safety tests for its approved use. However, like any medication, it may affect people differently based on factors such as other medications they are taking or their overall health.12345

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

Unlike the standard treatments for rheumatoid arthritis, which often include DMARDs like methotrexate and biologics targeting specific immune pathways, disulfiram is unique because it is originally an anti-alcoholism drug with potential anti-inflammatory effects. Researchers are excited about disulfiram because it might modulate the immune system differently, potentially reducing inflammation and joint damage in a new way. This new mechanism of action could offer an alternative for patients who don't respond well to existing therapies, providing a fresh hope for better management of rheumatoid arthritis.

What evidence suggests that disulfiram might be an effective treatment for rheumatoid arthritis?

Research suggests that disulfiram, a drug typically used to treat alcohol addiction, might aid in managing rheumatoid arthritis (RA). Early laboratory studies have shown that disulfiram can reduce inflammation and improve bodily function by blocking specific pathways that cause inflammation. Specifically, it inhibits pathways linked to joint inflammation and RA severity. Initial research also indicates it might reduce the activation of inflammasomes, which can worsen RA symptoms. Although more studies with people are needed, these findings suggest disulfiram could help manage RA by directly targeting inflammation. Participants in this trial will receive either disulfiram or a placebo to assess its effectiveness in managing RA symptoms.13567

Who Is on the Research Team?

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Beatriz Y Hanaoka, MD, MSc

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with active rheumatoid arthritis who are overweight or obese (BMI ≥25), on stable RA medication, and willing to avoid alcohol during the study. People with certain health conditions like severe liver, kidney, heart issues, other autoimmune diseases, recent alcohol dependence, pregnancy, or allergies to disulfiram cannot join.

Inclusion Criteria

Active disease defined as Clinical Disease Activity Index (CDAI) >10
Willingness to abstain from alcohol for the duration of the study
Ability and willingness to comply with study procedures
See 4 more

Exclusion Criteria

Current or recent alcohol dependence (based on screening, e.g., AUDIT)
Pregnancy or breastfeeding
Known hypersensitivity to disulfiram or other thiuram derivatives
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either disulfiram 250 mg daily or placebo for 12 weeks

12 weeks
Weekly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Disulfiram

Trial Overview

The study tests whether disulfiram (a drug usually used for alcohol use disorder) can safely reduce inflammation in people with active rheumatoid arthritis and obesity. Participants will be randomly assigned to take either disulfiram or a placebo daily for 12 weeks without knowing which one they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DisulfiramExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Presbyterian Health Foundation

Collaborator

Citations

NCT07534332 | Disulfiram in Rheumatoid Arthritis

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