<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/NCT02226601</url>
  </required_header>
  <id_info>
    <org_study_id>CognAp</org_study_id>
    <nct_id>NCT02226601</nct_id>
  </id_info>
  <brief_title>Aprepitant to Mitigate Opioids' Cognitive Side Effects</brief_title>
  <official_title>Aprepitant to Mitigate Opioids' Cognitive Side Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Morphine and similar substances (called opioids) are often prescribed for moderate to severe&#xD;
      pain, such as after a surgery, thus allowing for minimal pain and a better recovery.&#xD;
      Unfortunately various, non-dangerous side effects from opioids occur often that limit the way&#xD;
      patients feel and can take of themselves, despite otherwise good pain control and minimal&#xD;
      limitations from the surgery itself.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this proposed study the investigators want to examine if the drug aprepitant can decrease&#xD;
      the so called &quot;cognitive impairments&quot; opioids may cause, such as drowsiness, loopiness and&#xD;
      feeling &quot;high&quot;.&#xD;
&#xD;
      This would allow for a better recovery period, in which patients can be more &quot;themselves&quot;,&#xD;
      participate in activities around them and move forward.&#xD;
&#xD;
      Subjects scheduled for elective surgeries with expected opioid medication for moderate to&#xD;
      severe pain and good functional status shortly after surgery will be randomized to receive&#xD;
      either aprepitant or placebo shortly before their surgery and for two more days thereafter.&#xD;
&#xD;
      A telephone interview for cognitive status and several specific questions will be used to&#xD;
      assess the effect of aprepitant on the subjects' cognitive and functional status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive function</measure>
    <time_frame>3 days post-operatively</time_frame>
    <description>questionnaires</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Aprepitant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aprepitant&#xD;
40 mg IV pre-operatively&#xD;
40 mg PO post-op day #1&#xD;
40 mg PO post-op day #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>electrolyte (0.9% NaCl) infusion) pre-operatively&#xD;
capsule without medication on post-op day #1&#xD;
capsule without medication on post-op day #2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant</intervention_name>
    <description>3 days perioperative Aprepitant once a day</description>
    <arm_group_label>Aprepitant</arm_group_label>
    <other_name>Emend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 days perioperative Placebot once a day</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy English speaking, opioid-naive consenting adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current or very recent (&lt; 3 months) opioid therapy&#xD;
&#xD;
          -  morbid obesity&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists&#xD;
             (warfarin), hormonal contraceptives&#xD;
&#xD;
          -  acute or chronic infections&#xD;
&#xD;
          -  immunocompromised status&#xD;
&#xD;
          -  hemodynamically unstable, hemorrhage (bleeding)&#xD;
&#xD;
          -  recent surgery&#xD;
&#xD;
          -  pregnancy, nursing&#xD;
&#xD;
          -  younger than 18 years old&#xD;
&#xD;
          -  not proficient of the English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Schoenhage, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai Schoenhage, MD</last_name>
    <phone>5206260373</phone>
    <email>kschoenhage@anesth.arizona.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kai Schoenhage, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.</citation>
    <PMID>22260216</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>May 29, 2015</last_update_submitted>
  <last_update_submitted_qc>May 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Kai Schoenhage</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>drowsiness</keyword>
  <keyword>loopiness</keyword>
  <keyword>nausea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</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/NCT02226601
org study id: CognAp
nct id: NCT02226601
lead sponsor: 
has dmc: No
Morphine and similar substances (called opioids) are often prescribed for moderate to severe
      pain, such as after a surgery, thus allowing for minimal pain and a better recovery.
      Unfortunately various, non-dangerous side effects from opioids occur often that limit the way
      patients feel and can take of themselves, despite otherwise good pain control and minimal
      limitations from the surgery itself.
In this proposed study the investigators want to examine if the drug aprepitant can decrease
      the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and
      feeling "high".

      This would allow for a better recovery period, in which patients can be more "themselves",
      participate in activities around them and move forward.

      Subjects scheduled for elective surgeries with expected opioid medication for moderate to
      severe pain and good functional status shortly after surgery will be randomized to receive
      either aprepitant or placebo shortly before their surgery and for two more days thereafter.

      A telephone interview for cognitive status and several specific questions will be used to
      assess the effect of aprepitant on the subjects' cognitive and functional status.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: cognitive function
time frame: 3 days post-operatively
description: questionnaires
arm group label: Aprepitant
arm group type: Active Comparator
description: Aprepitant
40 mg IV pre-operatively
40 mg PO post-op day #1
40 mg PO post-op day #2
arm group label: Placebo
arm group type: Placebo Comparator
description: electrolyte (0.9% NaCl) infusion) pre-operatively
capsule without medication on post-op day #1
capsule without medication on post-op day #2
intervention type: Drug
intervention name: Aprepitant
description: 3 days perioperative Aprepitant once a day
arm group label: Aprepitant
other name: Emend
intervention type: Drug
intervention name: Placebo
description: 3 days perioperative Placebot once a day
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kai Schoenhage, MD
role: Principal Investigator
affiliation: University of Arizona
last name: Kai Schoenhage, MD
phone: 5206260373
email: kschoenhage@anesth.arizona.edu
facility: 
status: Recruiting
investigator: 
country: United States
citation: Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
PMID: 22260216
responsible party type: Principal Investigator
investigator affiliation: University of Arizona
investigator full name: Kai Schoenhage
investigator title: Assistant Professor
mesh term: Cognitive Dysfunction
mesh term: Aprepitant