GWICTIC: NAC Mechanistic Study in Gulf War Veterans

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

During the 1990-91 Gulf War (GW), military personnel were exposed to numerous chemical and environmental agents during deployment including spraying of pesticides, petroleum combustion products, and nerve gas. Exposure to these chemical and environmental agents can damage cell function and more specifically, mitochondrial function, which negatively affects energy production and can lead to oxidative stress and neuroinflammation. Animal models using similar exposures have documented this in the central nervous system (CNS) compartment. This disruption in mitochondrial function and energy production is likely tied to resulting symptoms of Gulf War Illness (GWI) including fatigue, headaches, joint and muscle pain, gastrointestinal and sleep disturbances, neurologic and neuropsychological symptoms, respiratory issues, and cardiovascular problems. The Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) plans to evaluate N-Acetyl Cysteine (NAC) as a promising approach to help the CNS recover from chronic oxidative stress and depletion of antioxidants. The Congressionally Directed Medical Research Program's (CDMRP's) two Gulf War Illness Consortiums (GWICs) and others have added to the growing evidence of the role of CNS oxidative stress and neuroinflammation in symptoms of GWI, yet there is little definitive work on the delivery of antioxidants to the CNS environment. In this mechanistic study, we aim to determine if NAC has the ability to target mitochondrial dysfunction and reverse oxidative stress in the CNS. Based on our early experiences with antioxidants in GWI and other complex disease states along with the proven record of NAC in reducing glutathione (GSH) deficits, it is possible that this antioxidant will help to restore mitochondrial function and provide a more targeted approach to improve outcomes in Veterans with GWI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04987775
Study type	Interventional
Source	Nova Southeastern University
Contact	Nancy Klimas, MD
Phone	9542622855
Email	nklimas@nova.edu
Status	Recruiting
Phase	Early Phase 1
Start date	November 30, 2023
Completion date	September 2024

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See also
Status	Clinical Trial	Phase
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Completed	`NCT03342482` - Glutamate Neuro-Excitotoxicity in GWI	N/A
Completed	`NCT01264471` - Mechanisms of Mitochondrial Defects in Gulf War Syndrome	N/A
Terminated	`NCT03547869` - Transcranial Direct Current Stimulation for Pain Treatment in Gulf War Illness.	N/A
Recruiting	`NCT05675878` - Confirmation of Diet as a Treatment for Gulf War Illness	Phase 3
Recruiting	`NCT05736146` - Validating Gulf War Illness Blood Biomarkers
Completed	`NCT03560830` - START & STOPP in GWI
Recruiting	`NCT05355272` - Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)	Phase 2
Terminated	`NCT04712071` - Ketamine in Veterans With Gulf War Illness	Early Phase 1
Completed	`NCT03030794` - Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS	N/A
Completed	`NCT04638998` - Assessing Neuroinflammation in GWI Using MRS
Completed	`NCT02804828` - Mitochondrial Cocktail for Gulf War Illness	N/A
Recruiting	`NCT02848417` - Glutathione vs. Curcumin Clinical Trial	Phase 1/Phase 2
Recruiting	`NCT00956150` - Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex	Phase 1
Completed	`NCT00018707` - Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress	N/A
Not yet recruiting	`NCT05992311` - Clinical Evaluation of Montelukast in Veterans With Gulf War Illness	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

GWICTIC: NAC Mechanistic Study in Gulf War Veterans — NAC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms