The purpose of this study is to determine if modafinil is more effective than placebo in the
treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been
deployed to Iraq or Afghanistan.
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Locations near you
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Full eligibility criteria for NCT01726088
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
OEF/OIF Veteran with a history of deploying to Afghanistan or Iraq
male 20-60 years of age
meets Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for PTSD
competent to give informed consent
access to a telephone
stable psychotropic medication regimen for a minimum of four weeks prior to enrollment
able and willing to complete the required schedule of evaluations (Baseline in person, 1 week by phone, 2 week in person, 4 week in person)
diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
current substance abuse or dependence
history of seizure disorder or severe traumatic brain injury
history of attempted suicide within the previous two years or active suicidal ideation within the past month
currently taking benzodiazepines except for bedtime dosing only
currently taking stimulant medication
known allergic reaction to modafinil or currently taking medication
that may have altered metabolism if taken with modafinil: Tricyclic antidepressants
(amitriptyline; nortriptyline; desipramine; imipramine; CNS stimulants (amphetamine; d-ampthetamine; atomoxetine); Carbamazepine; Phenytoin; Phenobarbitol; Rifampin; Ketaconazole; MAO Inhibitors (isoniazid; selegiline); Warfarin; Diazepam; Mephenytoin; Cyclosporine; Theophylline
All locations for NCT01726088
United States (1)
CAVHS Eugene Towbin VA Medical Center
North Little Rock, Arkansas, United States, 72114
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View full eligibility
Tris trial is registered with FDA with number: NCT01726088. The sponsor of the trial is Biomedical Research Foundation and it is looking for 40 volunteers for the current phase.
Official trial title: A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD
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