Research Examining Gulf War Illness in Our Nations Service Members (REGIONS)
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ClinicalTrials.gov Identifier: NCT01846182 |
Recruitment Status :
Terminated
(Terminated by Funder)
First Posted : May 3, 2013
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gulf War Illness | Drug: Duloxetine Drug: Pregabalin Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Three arms comparing placebo to duloxetine and pregabalin |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | RCT of Duloxetine & Pregabalin for the Treatment of Gulf War Illness in Veterans |
Actual Study Start Date : | June 24, 2015 |
Actual Primary Completion Date : | August 1, 2019 |
Actual Study Completion Date : | August 1, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group 1
60 mg of duloxetine in the AM for 20 weeks and placebo in PM
|
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 and placebo in AM
|
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 |
- Pain by Likert Scale [ Time Frame: 120 days ]Likert scale of pain rating
- Side Effects [ Time Frame: Assessed every 2 weeks ]Side effects checklist
- Multiple and Unreliable [ Time Frame: Assessed every 2 weeks up to 34 weeks ]Reliability of measurement is highly suspect and data are not suitable for analysis.

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Ages Eligible for Study: | 44 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846182
United States, Texas | |
Central Texas Veterans Health Care System, Temple, TX | |
Temple, Texas, United States, 76504 | |
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX | |
Waco, Texas, United States, 76711 |
Study Chair: | Charles J Foulks, M.D. | Central Texas Veterans Health Care System, Temple, TX |
Documents provided by VA Office of Research and Development:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01846182 |
Other Study ID Numbers: |
SPLD-016-12F 6125 ( Other Identifier: Clinical Science Research & Development ) |
First Posted: | May 3, 2013 Key Record Dates |
Results First Posted: | March 12, 2021 |
Last Update Posted: | March 12, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Gulf War Illness Pregabalin Duloxetine |
Gulf War Veterans Cymbalta Lyrica |
Pregabalin Duloxetine Hydrochloride Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Antidepressive Agents Dopamine Agents |