Gulf War Illness | Research Examining Gulf War Illness in Our Nations Service Members
Gulf War Illness research study
What is the primary objective of this study?
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 a complex of symptoms that typically include widespread chronic pain, persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS. The lack of progress in finding effective treatments for GWI, and the similarities between GWI and FMS, provides a rationale for determining if these medications can provide relief to Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.
Who is eligible to participate?
Inclusion Criteria: - 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 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 Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Gulf War Illness
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Duloxetineserotonin norepinephrine reuptake inhibitor
Drug:Pregabalinalpha-2-alpha subunit calcium channel ligand
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group 160 mg of duloxetine in the AM for 20 weeks
Group 2300 mg of pregabalin in the PM for 20 weeks
Start Date: June 24, 2015
Completed Date: January 1, 2021
Phase: Phase 2
Primary Outcome: Pain , Safety, tolerability
Secondary Outcome: Side Effects
Study sponsors, principal investigator, and references
Principal Investigator: Dena Davidson, PhD
Lead Sponsor: VA Office of Research and Development