Warrior Connection – 10.11.15

Warrior Connection covered medical research programs needing vets.

Researcher contacted me and ask that all be notified.....Study out of Texas.....
Purpose
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.

Condition Intervention Phase
Gulf War Illness
Drug: Duloxetine
Drug: Pregabalin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of Duloxetine & Pregabalin for the Treatment of Gulf War Illness in Veterans

Resource links provided by NLM:

Drug Information available for: Duloxetine Duloxetine hydrochloride Pregabalin
U.S. FDA Resources 

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
Pain , Safety, tolerability [ Time Frame: Assessed every 2 weeks up to 34 weeks ] [ Designated as safety issue: No ]
Pain as measured by a 10-point Visual Analog scale Physical component of the SF-36 (Veteran version) Side Effects Check list

Secondary Outcome Measures:
Side Effects [ Time Frame: Assessed every 2 weeks ] [ Designated as safety issue: No ]
Side effects checklist

Estimated Enrollment: 180
Study Start Date: June 2015
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
60 mg of duloxetine in the AM for 20 weeks
Drug: Duloxetine
serotonin norepinephrine reuptake inhibitor
Other Name: Cymbalta
Drug: Placebo
Placebo
Active Comparator: Group 2
300 mg of pregabalin in the PM for 20 weeks
Drug: Pregabalin
alpha-2-alpha subunit calcium channel ligand
Other Name: Lyrica
Drug: Placebo
Placebo
Placebo Comparator: Group 3
placebo in the AM & PM for 20 weeks
Drug: Placebo
Placebo

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 a complex of symptoms that typically include widespread chronic pain, persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep disturbances and unexplained fatigue. This symptom profile is similar to that of fibromyalgia syndrome (FMS), a multi-symptom condition similar to GWI. Whereas, effective treatments for GWI have yet to be found, progress has been made in identifying medications to treat FMS. For example, the FDA has approved a number of medications including Duloxetine and Pregabalin for the treatment of FMS. Compared to placebo (PBO) Duloxetine (a serotonin norepinephrine reuptake inhibitor) and Pregabalin (an alpha-2-alpha-subunit calcium-channel ligand) significantly improved pain responses and fatigue. The capacity of Duloxetine to increase central levels of serotonin and norepinephrine as well as the more complex alterations of neurotransmitters and CNS mediators of pain attributed to pregabalin are thought to be responsible for the medication's effects on pain, mood and sleep. Clinical practice and one open-label trial support the use of these medications in combination to achieve optimal symptom improvement amongst GWI sufferers; however, such combinations have not been formally tested in randomized controlled trials. The lack of progress in finding effective treatments for GWI, and the similarities between GWI and FMS, provides a rationale for determining if these FDA approved medications can provide significant symptomatic relief to Veterans who suffer from GWI. Central Texas is home to one of the highest number of Gulf War Veterans in the nation, thus our research team is ideally situated to conduct the proposed study. In a randomized, double-blind, controlled trial, 180 Veterans who meet defining criteria for GWI and whose symptom profile includes chronic widespread pain and sleep disturbances will be treated with one of the following medications; 1) AM Duloxetine+ PM placebo (PBO); 2) PM Pregabalin + AM PBO or 3) AM PBO + PM PBO. All active treatments will titrate from a lower dose in 2-week increments to the full therapeutic doses (FDA-approved for FMS). The outcome of the PBO double-dummy period will be compared statistically with 18 weeks of active therapy (weeks 5-22).

Eligibility

Ages Eligible for Study: 38 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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 & July 1991
English speaking and able to understand the consent form and study questionnaires
Willing to be randomized to treatment and participate in 3-month follow up
men & women between the ages of 38 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 Criteria:

Unstable or poorly controlled chronic medical illness such as Diabetes type-II, HTN, heart disease, endocrine disorders, narrow angle glaucoma
Significant Central Nervous System disease including 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 MAOIs within 2 weeks of evaluation; Active ongoing use of the following agents: venlafaxine, desvenlafaxine, dexfenfluramine, fenfluramine, linezolid, milnacipran, phentermine, thioridazine, tryptophan, tramadol, muscle relaxants, opiates, antidepressants, anticonvulsants, benzodiazepines
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
Any regional pain syndromes (i.e. chronic back pain)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 

Contacts
Contact: Dena Davidson, PhD (254) 297-5169 Dena.Davidson@va.gov 
Contact: Peggy J Pazzaglia, MD (254) 624-5765 Peggy.Pazzaglia@va.gov 

Locations
United States, Texas
Central Texas Veterans Health Care System, Temple, TX Recruiting
Temple, Texas, United States, 76504
Contact: Christine A Kuhn, MSN BSN 254-297-3954 Christine.Kuhn@va.gov  
Contact: Randy Tea, MA (254) 297-3950 Randy.Tea@va.gov  
Principal Investigator: Dena Davidson, PhD  
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX Recruiting
Waco, Texas, United States, 76711
Contact: Dena Davidson, PhD 254-297-5169 Dena.Davidson@va.gov  
Sponsors and Collaborators
VA Office of Research and Development
Texas A&M University
Baylor University
Investigators
Principal Investigator: Dena Davidson, PhD Central Texas Veterans Health Care System, Temple, TX

Ok Georgetown study will be recruiting soon in DC.....this is the study to get FMRI-DT done like his previous study where we had 31 gulf war vets that showed abnormality in white brain matter. If you definitely want to do this they have started taking your names, contact phone number and email address. You can call them to get on the list ...call 202-687-8231. They will call you when they start precscreening by phone. You can also email them at GWIRESEARCH@GEORGETOWN.EDU give them your name, that gulf war deployed and contact info re your phone number and email address.

The consortium first study that involves Boston, Dr Klimas Florida, and Australian university and in a year Texas will start....contact Joanna Cirillo at 617-638-5834. Or GWIC@bu.edu. It takes like from 9am to 2 pm.....you get blood drawn(which goes to Dr Klimas in fld) your sputum ie spit is sent to Australia and you get an hour of scans they do like 10 scans. They also do basic physical re checking BP, P, weight, fibromyalgia, etc...and neuro cognitive testing. We need a total of 300 thru this study, Boston hopes to get 175. So we need those that served in first gulf war in theater!