Actively Recruiting

Early Phase 1
Age: 47Years - 70Years
All Genders
NCT04987775

GWICTIC: NAC Mechanistic Study in Gulf War Veterans

Led by Nova Southeastern University · Updated on 2025-07-08

170

Participants Needed

7

Research Sites

121 weeks

Total Duration

On this page

Sponsors

N

Nova Southeastern University

Lead Sponsor

R

RTI International

Collaborating Sponsor

AI-Summary

What this Trial Is About

This mechanistic study will test if NAC affects chronic oxidative stress and depletion of antioxidants in GWI participants. Blood specimen collection and neuroimaging will be used to determine whether NAC affects serum glutathione (GSH) concentration and oxidative stress in the CNS when compared to placebo.

CONDITIONS

Official Title

GWICTIC: NAC Mechanistic Study in Gulf War Veterans

Who Can Participate

Age: 47Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 47 and 70 years
  • Served in the Gulf War Theater any time between August 1990 and July 1991
  • Meets the modified Kansas case definition for Gulf War Illness, allowing stable treated conditions like hypertension, diabetes, PTSD, major depressive disorder, or mild traumatic brain injury
  • Able to provide written informed consent
  • Willing to attend follow-up visits
Not Eligible

You will not qualify if you...

  • Current or past major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementia, epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's disease, Alzheimer's disease, alcoholism, or drug abuse
  • Severe claustrophobia or difficulty undergoing MRI (for MRS substudy)
  • Presence of ferrous implanted medical devices or metal fragments under the skin (for MRS substudy)
  • Heavy alcohol use exceeding 15 drinks per week or tobacco use exceeding 20 cigarettes per day
  • Chronic active infections such as HIV, Hepatitis B, or Hepatitis C
  • Renal disease with serum creatinine over 2.0 mg/dL
  • Liver disease with bilirubin over 2.5 mg/dL or high liver enzymes
  • Uncontrolled diabetes with HgbA1c above 7.5 without adequate medical care
  • Diagnosed vascular disease including congestive heart failure
  • Diagnosed bleeding disorders or use of blood-thinning medications
  • Use of stavudine or didanosine for more than 7 days within 30 days before screening
  • Diagnoses that explain fatigue symptoms
  • Scheduled surgery during study or surgery within 6 weeks before screening
  • Pregnancy
  • Currently on dialysis
  • Recent or current use of antiviral medications for more than 7 days within 30 days before screening
  • Participation in another investigational clinical trial within 6 weeks before consent or planning to participate during this study
  • Use of herbal medicine within 30 days before consent and screening blood draw

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

VA Palo Alto Health Care System War Related Illness and Injury Study Center

Palo Alto, California, United States, 94304

Actively Recruiting

2

Nova Southeastern University

Fort Lauderdale, Florida, United States, 33314

Actively Recruiting

3

Boston University Medical School

Boston, Massachusetts, United States, 02215

Active, Not Recruiting

4

VA New Jersey Health Care System War Related Illness and Injury Study Center

East Orange, New Jersey, United States, 07018

Actively Recruiting

5

Weill Cornell Medical College

New York, New York, United States, 10021

Active, Not Recruiting

6

RTI International

Durham, North Carolina, United States, 27709

Active, Not Recruiting

7

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

N

Nancy Klimas, MD

CONTACT

K

Karen Kesler, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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