Status:
TERMINATED
Ketamine in Veterans With Gulf War Illness
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
Conditions:
Gulf War Syndrome
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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, debil...
Detailed Description
Recruitment for this study starts after protocol approval by the BCM IRB, MEDVAMC R\&D, and DoD HRPO. All study procedures are for research only. Potential subjects will be recruited (i) from the Hou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04712071
Start Date
February 1 2021
End Date
February 16 2022
Last Update
March 3 2022
Active Locations (1)
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1
Marijn Lijffijt
Houston, Texas, United States, 77030