GWICTIC: NAC Mechanistic Study in Gulf War Veterans
ConditionGulf War Syndrome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age47-70
SponsorNova Southeastern University
About this trial
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
Qualifiers
47 to 70 years
Served in the Gulf War Theater for any period between August 1990 and July 1991.
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- N-Acetyl Cysteine
- Placebo
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nova Southeastern University
Lead sponsor
RTI International
Collaborator
Boston University
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov