<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726088</url>
  </required_header>
  <id_info>
    <org_study_id>CAVHS209470-1</org_study_id>
    <secondary_id>5P20RR020146-09</secondary_id>
    <secondary_id>8P20GM103425-09</secondary_id>
    <nct_id>NCT01726088</nct_id>
  </id_info>
  <brief_title>Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)</brief_title>
  <official_title>A Double-Blind, Placebo-Controlled Trial of Modafinil in OEF/OIF Combat Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biomedical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Research Resources (NCRR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Biomedical Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if modafinil is more effective than placebo in the&#xD;
      treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been&#xD;
      deployed to Iraq or Afghanistan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a high rate of posttraumatic stress disorder (PTSD) in soldiers exposed to combat in&#xD;
      Operations Enduring Freedom and Iraqi Freedom (OEF/OIF). Unfortunately, currently available&#xD;
      treatments for combat-related PTSD have produced modest treatment gains at best. New&#xD;
      treatment strategies that can be directed toward objectively measured correlates of PTSD are&#xD;
      urgently needed.&#xD;
&#xD;
      Specific Aims: 1) To determine if there is evidence for the effectiveness and tolerability of&#xD;
      adjunctive modafinil in the treatment of combat-related PTSD. We hypothesize that OEF/OIF&#xD;
      veterans with PTSD randomized to modafinil 100mg/day for four weeks will experience more&#xD;
      improvement in PTSD symptoms than OEF/OIF veterans with PTSD randomized to placebo treatment&#xD;
      for four weeks. 2) To determine if PTSD symptom severity is associated with&#xD;
      electrophysiological and neuropsychological measures of pre-attention and attention and if&#xD;
      these measures change to a greater degree in participants randomized to modafinil versus&#xD;
      those randomized to placebo. We hypothesize modafinil treatment will result in greater&#xD;
      changes in electrophysiological and neuropsychological measures of pre-attention and&#xD;
      attention than placebo treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinician Administered PTSD Scale (CAPS)</measure>
    <time_frame>Change in CAPS from baseline to 4 weeks</time_frame>
    <description>The CAPS is the gold standard measure of PTSD symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>eye-gaze tracking to facial stimuli</measure>
    <time_frame>change in eye-gaze tracking from baseline to 4 weeks</time_frame>
    <description>a measure of attentional bias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Stroop</measure>
    <time_frame>Change in Modified Stroop from baseline to 4 weeks</time_frame>
    <description>a measure of attentional bias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>event related potentials</measure>
    <time_frame>Change in P50 from baseline to 4 weeks</time_frame>
    <description>P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>modafinil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Modafinil</intervention_name>
    <description>we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.</description>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_label>modafinil</arm_group_label>
    <other_name>Provigil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OEF/OIF Veteran with a history of deploying to Afghanistan or Iraq&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  male 20-60 years of age&#xD;
&#xD;
          -  meets Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for PTSD&#xD;
&#xD;
          -  competent to give informed consent&#xD;
&#xD;
          -  access to a telephone&#xD;
&#xD;
          -  stable psychotropic medication regimen for a minimum of four weeks prior to enrollment&#xD;
&#xD;
          -  able and willing to complete the required schedule of evaluations (Baseline in person,&#xD;
             1 week by phone, 2 week in person, 4 week in person)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder&#xD;
&#xD;
          -  current substance abuse or dependence&#xD;
&#xD;
          -  history of seizure disorder or severe traumatic brain injury&#xD;
&#xD;
          -  history of attempted suicide within the previous two years or active suicidal ideation&#xD;
             within the past month&#xD;
&#xD;
          -  currently taking benzodiazepines except for bedtime dosing only&#xD;
&#xD;
          -  currently taking stimulant medication&#xD;
&#xD;
          -  known allergic reaction to modafinil or currently taking medication&#xD;
&#xD;
          -  that may have altered metabolism if taken with modafinil: Tricyclic antidepressants&#xD;
             (amitriptyline; nortriptyline; desipramine; imipramine; CNS stimulants (amphetamine;&#xD;
             d-ampthetamine; atomoxetine); Carbamazepine; Phenytoin; Phenobarbitol; Rifampin;&#xD;
             Ketaconazole; MAO Inhibitors (isoniazid; selegiline); Warfarin; Diazepam; Mephenytoin;&#xD;
             Cyclosporine; Theophylline&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim A Kimbrell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Arkansas VA Healthcare System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tim A Kimbrell, MD</last_name>
    <phone>501-257-1084</phone>
    <email>timothy.kimbrell@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeffry M Pyne, MD</last_name>
    <phone>501-257-1983</phone>
    <email>jeffrey.pyne@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CAVHS Eugene Towbin VA Medical Center</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan M Jegley, LMSW</last_name>
      <phone>501-257-1731</phone>
      <email>susan.jegley@va.gov</email>
    </contact>
    <investigator>
      <last_name>Tim A Kimbrell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffrey M Pyne, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Biomedical Research Foundation</investigator_affiliation>
    <investigator_full_name>Timothy Kimbrell</investigator_full_name>
    <investigator_title>Staff Physician; Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Modafinil</keyword>
  <keyword>p50</keyword>
  <keyword>Attentional Bias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Modafinil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726088
org study id: CAVHS209470-1
secondary id: 5P20RR020146-09
secondary id: 8P20GM103425-09
nct id: NCT01726088
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
There is a high rate of posttraumatic stress disorder (PTSD) in soldiers exposed to combat in
      Operations Enduring Freedom and Iraqi Freedom (OEF/OIF). Unfortunately, currently available
      treatments for combat-related PTSD have produced modest treatment gains at best. New
      treatment strategies that can be directed toward objectively measured correlates of PTSD are
      urgently needed.

      Specific Aims: 1) To determine if there is evidence for the effectiveness and tolerability of
      adjunctive modafinil in the treatment of combat-related PTSD. We hypothesize that OEF/OIF
      veterans with PTSD randomized to modafinil 100mg/day for four weeks will experience more
      improvement in PTSD symptoms than OEF/OIF veterans with PTSD randomized to placebo treatment
      for four weeks. 2) To determine if PTSD symptom severity is associated with
      electrophysiological and neuropsychological measures of pre-attention and attention and if
      these measures change to a greater degree in participants randomized to modafinil versus
      those randomized to placebo. We hypothesize modafinil treatment will result in greater
      changes in electrophysiological and neuropsychological measures of pre-attention and
      attention than placebo treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Clinician Administered PTSD Scale (CAPS)
time frame: Change in CAPS from baseline to 4 weeks
description: The CAPS is the gold standard measure of PTSD symptoms
measure: eye-gaze tracking to facial stimuli
time frame: change in eye-gaze tracking from baseline to 4 weeks
description: a measure of attentional bias
measure: Modified Stroop
time frame: Change in Modified Stroop from baseline to 4 weeks
description: a measure of attentional bias
measure: event related potentials
time frame: Change in P50 from baseline to 4 weeks
description: P50 potential a measure of level of arousal or pre-attentional processing at 3 interstimulus intervals-ISIs
arm group label: modafinil
arm group type: Active Comparator
description: Study participants randomized to the active arm of the study will take modafinil 100mg capsules orally each day for 4 weeks.
arm group label: Sugar Pill
arm group type: Placebo Comparator
description: Study participants randomized to the placebo arm of the study will take matching capsules orally each day for 4 weeks.
intervention type: Drug
intervention name: Modafinil
description: we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
arm group label: Sugar Pill
arm group label: modafinil
other name: Provigil
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tim A Kimbrell, MD
role: Principal Investigator
affiliation: Central Arkansas VA Healthcare System
last name: Tim A Kimbrell, MD
phone: 501-257-1084
email: timothy.kimbrell@va.gov
last name: Jeffry M Pyne, MD
phone: 501-257-1983
email: jeffrey.pyne@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Biomedical Research Foundation
investigator full name: Timothy Kimbrell
investigator title: Staff Physician; Associate Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Modafinil