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NCT04712071

Ketamine in Veterans With Gulf War Illness

Terminated EARLY_PHASE1 Last updated 3 March 2022
What this trial tests

EARLY_PHASE1 trial testing Ketamine Hydrochloride in Gulf War Syndrome in 1 participant. Terminated before completion.

Timeline
1 February 2021
Primary endpoint
16 February 2022
16 February 2022

Quick facts

Lead sponsorBaylor College of Medicine
PhaseEARLY_PHASE1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment1
Start date1 February 2021
Primary completion16 February 2022
Estimated completion16 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor College of Medicine

Who can join

18 and older, any sex, with Gulf War Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations.
    Vekhova KA, Namiot ED, Jonsson J, Schiöth HB. · · 2025 · cited 17× · PMID 39428602 · DOI 10.1002/cpt.3478

Verify or expand the search:

Other trials of Ketamine Hydrochloride

Trials testing the same drug.

Other recruiting trials for Gulf War Syndrome

Currently open trials in the same condition.

Other Baylor College of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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