TerminatedEarly Phase 1

Ketamine in Veterans With Gulf War Illness

Stopped: Due to the COVID pandemic we could not enroll more than one subject before funding was ending.

United States1 participantsStarted 2021-02-01

Plain-language summary

Up to one third of the 700,000 U.S. military veterans of the 1990-91 Gulf War have Gulf War Illness (GWI), a symptom complex characterized by a combination of chronic pain, cognitive impairment, debilitating fatigue, gastrointestinal complications, and other persistent symptoms. Epidemiologic studies of 1990-1991 Gulf War veterans have identified the short but intense combined exposure to insecticides (e.g., organophosphates, DEET, permethrin), pills with anti-nerve gas agent pyridostigmine bromide (PB), and low-level chemical nerve agents as likely candidates of GWI. Animal models have shown that these neurotoxicants could induce neuroinflammation which is marked by enhanced inflammatory cytokines, and activated microglia and astrocytes. Inflammation has been linked to GWI. Secondary effects of neuroinflammation and glia activation could be excessive glutamate-mediated neuronal activation. There is currently no treatment for symptoms of GWI. Ketamine is an N-methyl-D-aspartate receptor (NMDAR) antagonist. Besides blocking activation of NMDARs, a sub-anesthetic dose (0.5 mg/kg over 40 minutes) of ketamine could be an anti-inflammatory agent, and could protect microglia and astrocytes from being activated by inflammatory agents. This low dose of ketamine has also been shown to improve fatigue within 24 hours after a single infusion, and to improve inflammatory pain. This makes ketamine a feasible candidate for the treatment of inflammation-associated symptoms of GWI. This pilot study will examine if GWI is related to NMDAR functioning, testing effects of a single 40-minute intravenous infusion of 0.5 mg/kg of ketamine on GWI symptom severity in 21 veterans of the 1990-1991 Gulf War who meet Kansas case definition criteria of GWI.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Military veterans who served for any period of time in the Gulf War Theater of Operations between August of 1990 and July of 1991. * Cases must meet Kansas GWI case definition criteria. * Understand the study as described in the informed consent form, and be able to consent for study participation. Exclusion Criteria: * A physical or psychiatric illness explaining GWI case definition symptoms at the discretion of the PI. * History of seizures. * History of ECT or deep brain stimulation. * History of head injury with loss-of-consciousness over 15 minutes or no recollection of events. * Unstable serious illness at the discretion of the PI or study physician, including: * hepatic disease * renal disease * gastroenterologic disease * respiratory disease, * cardiovascular disease (including ischemic heart disease) * endocrinologic disease * neurologic disease * immunologic disease * hematologic disease. * Clinically significant EKG or laboratory values at the discretion of the study physician. * Uncontrolled hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg). * Family history or own history of schizophrenia or psychosis. * For at least two weeks before ketamine infusion, use of: * Antibiotics * Antiviral medication * anti-inflammatory medications (including NSAIDS) for at least two weeks before ketamine infusion. * Being pregnant or breastfeeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in 40Hz Auditory steady state response (ASSR) EEG power

Timeframe: pre-treatment baseline, 35 minutes after start of infusion (close to ketamine peak) and 95 minutes after start of infusion

Trial details

NCT IDNCT04712071

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-16

View on ClinicalTrials.gov More Gulf War Syndrome trials