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New treatment option for Gulf War Syndrome
Official title GWICTIC: NAC Mechanistic Study in Gulf War Veterans
ClinicalTrials.gov ID: NCT04987775
What this study is testing
What is N-Acetyl Cysteine?
N-Acetyl Cysteine is an investigational medicine, given as an once-daily, being studied as a potential treatment for gulf war syndrome.
Also referred to as NAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 47 to 70
You may be able to join if
- 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:
- Allowance of normal illness of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and normal...
- Allowance of stable comorbid conditions such as Post Traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and mild Traumatic Brain...
You likely can't join if
- Self-report of current treated or untreated major depression with psychotic or melancholic features (as determined by self-report and Hamilton...
- 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...
- 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)
See the full eligibility 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:
- 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...
- Able to provide written consent to the study
- Agrees to participate in follow-up visits.
- 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...
- 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...
- 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...
- 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 treatment (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another treatment clinical trial of an...
- Any herbal medicine within 30 days prior to consent and screening blood draw
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Fort Lauderdale, Florida, United States
- Boston, Massachusetts, United States
- East Orange, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 47 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Fort Lauderdale, Florida, United States; Boston, Massachusetts, United States; East Orange, New Jersey, United States; New York, New York, United States; Durham, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.