Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • N-Acetyl Cysteine

    Drug

    900mg 2x daily

  • Placebo

    Drug

    Matching placebo bid

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: N-Acetyl Cysteine (NAC)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assess glutathione levels

Change in glutathione levels after NAC supplementation compared to placebo in participants with gulf war illness (GWI)

Time frame
Baseline to 8 weeks

Secondary outcomes

1

Change in glutathione levels

Measure the change of brain glutathione levels with magnetic resonance spectroscopy (MRS) in a subset of both arms of study at baseline and 8 weeks.

Time frame
Baseline to 8 Weeks
2

Change in number of participants with treatment-related adverse events

Change in number of participants with treatment-related adverse events from baseline to 16 weeks during the intervention period as assessed by a safety questionnaire.

Time frame
Baseline to 16 Weeks

Other outcomes

Sponsors and contacts

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Nova Southeastern University

Lead sponsor

RTI International

Collaborator

Boston University

Collaborator

Weill Medical College of Cornell University

Collaborator

Source ClinicalTrials.gov
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