NCT04987775 GWICTIC: NAC Mechanistic Study in Gulf War Veterans
| NCT ID | NCT04987775 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Nova Southeastern University |
| Condition | Gulf War Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 170 participants in total. It began in 2023-11-30 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 47 to 70 years * Served in the Gulf War Theater for any period between August 1990 and July 1991. * Meets modified Kansas case definition criteria for Gulf War Illness. The modified Kansas definition includes the following: 1. Allowance of normal illness of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment. 2. Allowance of stable comorbid conditions such as Post Traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and mild Traumatic Brain Injury (mTBI) that have not required hospitalization in the 2 years prior to recruitment. Severe TBI is excluded. * Able to provide written consent to the study * Agrees to participate in follow-up visits. Exclusion Criteria: * Self-report of current treated or untreated major depression with psychotic or melancholic features (as determined by self-report and Hamilton Depression Inventory (Ham-D)), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of central nervous system (CNS) disorders that may affect cognitive function (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or alcoholism or drug abuse * Severe claustrophobia or serious difficulty being in an MRI scanner or other enclosed space (MRS substudy only) * Presence of ferrous implanted medical devices or metal fragments or objects that are embedded under the skin (MRS substudy only) * Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day. * Chronic active infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) (self-report or antibody titer) * Renal disease (self-report or laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL) * Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \> 3 times the upper limits of normal) * Uncontrolled diabetes (HgbA1c \> 7.5) without adequate medical care. Individuals with HgbA1c \> 7.5 will be reviewed and judged by the PI or delegate; if potential participant has adequate medical care to manage diabetes, enrollment is allowed; otherwise HgbA1c \> 7.5 is exclusionary * Diagnosed vascular disease (including congestive heart failure) * Diagnosed bleeding disorders or use of blood-thinning medications * Receipt of stavudine or didanosine for more than 7 days within 30 days prior to screening * Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity * Are scheduled for a surgery during the period of study participation or had surgery within 6 weeks prior to screening * Pregnant (women only) Prohibited Concomitant or Prior Therapies * Currently on dialysis * Previous or current receipt of any antiviral medication, such as pegylated interferon, ribavirin, entecavir, tenofovir, or didanosine for more than 7 days within 30 days prior to screening * Participating in another interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study * Any herbal medicine within 30 days prior to consent and screening blood draw
Contact & Investigator
Nancy Klimas, MD
PRINCIPAL INVESTIGATOR
Nova Southeastern Univeristy
Frequently Asked Questions
Who can join the NCT04987775 clinical trial?
This trial is open to participants of all sexes, aged 47 Years or older, up to 70 Years, studying Gulf War Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04987775 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04987775 currently recruiting?
Yes, NCT04987775 is actively recruiting participants. Contact the research team at nklimas@nova.edu for enrollment information.
Where is the NCT04987775 trial being conducted?
This trial is being conducted at Palo Alto, United States, Fort Lauderdale, United States, Boston, United States, East Orange, United States and 3 additional locations.
Who is sponsoring the NCT04987775 clinical trial?
NCT04987775 is sponsored by Nova Southeastern University. The principal investigator is Nancy Klimas, MD at Nova Southeastern Univeristy. The trial plans to enroll 170 participants.