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Antioxidant

N-Acetyl Cysteine for Gulf War Syndrome (NAC Trial)

Phase < 1

Recruiting

Led By Nancy Klimas, MD

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently on dialysis

47 to 70 years

Must not have

Chronic active infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) (self-report or antibody titer)

Are scheduled for a surgery during the period of study participation or had surgery within 6 weeks prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 16 weeks

Summary

This trial will test if NAC can help veterans with Gulf War Illness by increasing antioxidants in their bodies. The goal is to reduce brain inflammation and improve symptoms like fatigue and pain. N-acetylcysteine (NAC) has been shown to reduce oxidative stress and inflammation in both human and animal models.

Who is the study for?

This trial is for Gulf War veterans aged 47-70 who served between August 1990 and July 1991, meet the criteria for Gulf War Illness, and can consent to the study. They must not have severe mental health issues or substance abuse problems, no recent participation in other trials, and should not be on dialysis or have certain chronic infections.

What is being tested?

The GWICTIC study is testing whether N-Acetyl Cysteine (NAC) can improve oxidative stress and antioxidant levels in those with Gulf War Syndrome compared to a placebo. It involves blood tests and neuroimaging to measure changes in serum glutathione concentration and brain oxidative stress.

What are the potential side effects?

While specific side effects are not listed here, NAC may generally cause gastrointestinal discomfort like nausea or diarrhea, skin rash, headache, dizziness or fatigue. Side effects from placebos are usually minimal but can include similar symptoms due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving dialysis.

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I am between 47 and 70 years old.

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I have not taken antiviral medications like interferon or ribavirin in the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have chronic infections like HIV, HBV, or HCV.

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I have had surgery within the last 6 weeks or will have surgery during the study.

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I have a bleeding disorder or take blood thinners.

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I have taken stavudine or didanosine for over a week in the last month.

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My kidney function is impaired with a creatinine level over 2.0 mg/dL.

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I do not have severe liver disease.

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I have been diagnosed with a heart or blood vessel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess glutathione levels

Secondary study objectives

Change in glutathione levels

Change in number of participants with treatment-related adverse events

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: N-Acetyl Cysteine (NAC)Active Control1 Intervention

Participants who are randomized to the intervention arm will receive N-Acetyl-L-Cysteine (Free-Form/NAC) 900mg two times a day for 8 weeks after the initiation of the first dose of study drug.

Group II: PlaceboPlacebo Group1 Intervention

Participants who are randomized to the placebo arm will take matching placebo two times a day for 8 weeks after the initiation of the first dose of study drug.

0 / 10Eligibility criteria met