Status:
TERMINATED
Research Examining Gulf War Illness in Our Nations Service Members
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Texas A&M University
Conditions:
Gulf War Illness
Eligibility:
All Genders
44-70 years
Phase:
PHASE2
Brief Summary
At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive. GWI refers to ...
Detailed Description
At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive. GWI refers to ...
Eligibility Criteria
Inclusion
- Living in Central Texas near Killeen, Austin, Temple or Waco
- Served on active military duty and deployed to the Persian Gulf region for some period between August 1990 \& July 1991
- English speaking and able to understand the consent form and study questionnaires
- Willing to be randomized to treatment and participate in 1-month follow up
- men \& women between the ages of 43 to 70
- meet Kansas GWI case definition for the diagnosis of GWI
- report a baseline score \> 4 on a 10-point Pain Visual Analog Scale (VAS)
- female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control (for example, oral contraceptives or Norplant; a reliable barrier method of birth control \[diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam); intrauterine devices; partner with vasectomy; or abstinence) during the study and for 2 months following the last dose of the study drug. \[Note that this inclusion criterion applies only to females of childbearing potential. Females of childbearing potential are defined as women not surgically sterilized and between menarche and 2 years post-menopause.\]
Exclusion
- Unstable or poorly controlled chronic medical illness such as Diabetes type-II, Hypertension (HTN), heart disease, endocrine disorders, narrow angle glaucoma
- Significant Central Nervous System disease including transient ischemic attacks (TIAs) or stroke, Dementia, syncopal episodes, severe head trauma, multiple sclerosis
- Serious or advanced heart disease or clinically relevant abnormal electrocardiogram (ECG), postural hypotension
- Untreated sleep apnea or body mass index placing patients at risk for undiagnosed sleep apnea (BMI\> 35 kg/m2)
- Diabetes type-I and patients with Diabetes type-II associated with peripheral neuropathy, hepatitis, liver failure/cirrhosis
- End stage renal disease
- History of hypersensitivity reaction to pregabalin, duloxetine, venlafaxine; active treatment with duloxetine or pregabalin; History of failure of duloxetine or pregabalin at therapeutic doses; history of angioedema reaction to pregabalin
- Active systemic infectious disease such as tuberculosis and HIV, shingles
- Autoimmune mediated illnesses such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma
- History of mental illness requiring hospitalization (depression, bipolar illness, post traumatic stress disorder, history of suicide attempts, psychosis, schizophrenia spectrum); Current major depression of dysthymia; patients lacking capacity to make medical decisions
- Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of evaluation; Active ongoing use of the following agents: desvenlafaxine, fenfluramine, linezolid, milnacipran, phentermine, tryptophan, tramadol, opiates
- Current (meets criterion within the last 6 months) for drug or alcohol dependence (except for nicotine and caffeine)
- Cancer other than non-melanoma skin cancers
- Women who are pregnant or desire to become pregnant, breastfeeding, who use unreliable contraception methods
- Those with occupations requiring use and/or operation of hazardous heavy equipment or professional drivers
- Patients for whom the potential risk outweighs the potential benefit in the opinion of the treating psychiatrist
Key Trial Info
Start Date :
June 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01846182
Start Date
June 24 2015
End Date
August 1 2019
Last Update
March 12 2021
Active Locations (2)
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1
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, United States, 76504
2
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, United States, 76711