<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/NCT04431206</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066136</org_study_id>
    <nct_id>NCT04431206</nct_id>
  </id_info>
  <brief_title>Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects</brief_title>
  <official_title>Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of participants that will receive an intravenous (IV) infusion of oxytocin&#xD;
      (naturally occurring hormone that is made in the brain).&#xD;
&#xD;
      In this study healthy volunteers and people with knee arthritis so severe that they may need&#xD;
      joint replacement are recruited for a one day study. Each study participant will have an IV&#xD;
      catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion.&#xD;
      Investigators will perform some tests to evaluate how oxytocin changes perceptions on the&#xD;
      skin. Investigators will study a painful perception by placing a probe on the skin and&#xD;
      heating it to 113 -117 degrees Fahrenheit (F) for 5 minutes. Each study participant will&#xD;
      score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises&#xD;
      during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. The&#xD;
      5 minute heating temperature will be determined according to the subjects pain rating during&#xD;
      the screening visit.&#xD;
&#xD;
      The main goal of the study is to determine the effect of oxytocin during and after a fixed&#xD;
      rate intravenous infusion on reduction in pain to a sustained heat stimulus in order to&#xD;
      generate a model for peripheral analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study healthy people or those with knee arthritis so severe that they may need joint&#xD;
      replacement are recruited for a one day study. Study participants will come to the Clinical&#xD;
      Research Unit (CRU) and one intravenous (IV) catheter will be inserted in the forearm for&#xD;
      oxytocin infusion. Participants in this study will receive oxytocin at a steady rate for 30&#xD;
      minutes. This information will be analyzed by another group at Stanford University in the&#xD;
      Pharmacokinetic/Pharmacodynamic (PK/PD) Core part of this application. Mathematics will be&#xD;
      utilized to calculate how quickly oxytocin moves from the blood to where it reduces pain.&#xD;
&#xD;
      Investigators will also do a pain test to determine how much oxytocin reduces pain. For this&#xD;
      Investigators will place a probe on the skin and heat it to 113 - 117 degrees for 5 minutes.&#xD;
      Study participants will score any pain they feel on a 0 to 10 scale, and most people find&#xD;
      that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0&#xD;
      to 10 scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 4, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group Oxytocin infusion</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>3 minutes prior to Oxytocin infusion</time_frame>
    <description>3 Minutes prior to the Oxytocin infusion Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>12 minutes after the start of Oxytocin infusion</time_frame>
    <description>12 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>27 minutes after the start of Oxytocin infusion</time_frame>
    <description>27 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>42 minutes after the start of Oxytocin infusion</time_frame>
    <description>42 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>57 minutes after the start of Oxytocin infusion</time_frame>
    <description>57 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>Beginning of the Oxytocin infusion</time_frame>
    <description>Simultaneously with the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>15 minutes after the start of Oxytocin infusion</time_frame>
    <description>15 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>30 minutes after the start of Oxytocin infusion</time_frame>
    <description>30 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>45 minutes after the start of Oxytocin infusion</time_frame>
    <description>45 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>60 minutes after the start of Oxytocin infusion</time_frame>
    <description>60 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>2 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>2 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>17 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>17 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>32 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>32 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>47 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>47 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>62 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>62 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>5 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>5 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>20 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>20 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>35 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>35 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>50 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>50 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>65 minutes after the beginning of the Oxytocin infusion</time_frame>
    <description>65 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin administered by IV infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin administered by IV infusion</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female &gt; 18 and &lt; 75 years of age, Body Mass Index (BMI) &lt;40.&#xD;
&#xD;
          2. Generally in good health as determined by the Principal Investigator based on prior&#xD;
             medical history, American Society of Anesthesiologists physical status 1, 2, or 3.&#xD;
&#xD;
          3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90&#xD;
             mmHg) resting heart rate 45-100 beats per minute) without medication. For knee&#xD;
             arthritis subjects, normal blood pressure or, for those with hypertension, pressure&#xD;
             controlled with anti-hypertensives and with a resting heart rate 45-100 beats per&#xD;
             minute.&#xD;
&#xD;
          4. Female subjects of child-bearing potential and those &lt; 1 year post-menopausal, must be&#xD;
             practicing highly effective methods of birth control such as hormonal methods (e.g.,&#xD;
             combined oral, implantable, injectable, or transdermal contraceptives), double barrier&#xD;
             methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or&#xD;
             cream), or total abstinence from heterosexual intercourse for a minimum of 1 full&#xD;
             cycle before study drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®&#xD;
&#xD;
          2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the&#xD;
             Principal Investigator, would place the subject at increased risk (active gynecologic&#xD;
             disease in which increased tone would be detrimental e.g., uterine fibroids with&#xD;
             ongoing bleeding), compromise the subject's compliance with study procedures, or&#xD;
             compromise the quality of the data&#xD;
&#xD;
          3. Women who are pregnant (positive result for serum pregnancy test at screening visit),&#xD;
             women who are currently nursing or lactating, women that have been pregnant within 2&#xD;
             years&#xD;
&#xD;
          4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines&#xD;
             or pain medications on a daily basis.&#xD;
&#xD;
          5. Subjects with current or history of ventricular tachycardia, atrial fibrillation or&#xD;
             prolonged QT interval.&#xD;
&#xD;
          6. Subjects with past or current history of hyponatremia or at risk for hyponatremia;&#xD;
             anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium,&#xD;
             carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride,&#xD;
             glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the&#xD;
             recreational drug ecstasy.&#xD;
&#xD;
          7. Subjects with a known latex allergy.&#xD;
&#xD;
          8. Subjects with a pain score rating of 1 or less during the initial training session to&#xD;
             a 5 minute heating of 45°C- 47 °C to the lower calf.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James C Eisenach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Regina Curry, RN</last_name>
    <phone>336-716-4294</phone>
    <email>RECURRY@WAKEHEALTH.EDU</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Regina Curry, RN</last_name>
      <phone>336-716-4294</phone>
      <email>RECURRY@WAKEHEALTH.EDU</email>
    </contact>
    <investigator>
      <last_name>James C Eisenach, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</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/NCT04431206
org study id: IRB00066136
nct id: NCT04431206
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a study of participants that will receive an intravenous (IV) infusion of oxytocin
      (naturally occurring hormone that is made in the brain).

      In this study healthy volunteers and people with knee arthritis so severe that they may need
      joint replacement are recruited for a one day study. Each study participant will have an IV
      catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion.
      Investigators will perform some tests to evaluate how oxytocin changes perceptions on the
      skin. Investigators will study a painful perception by placing a probe on the skin and
      heating it to 113 -117 degrees Fahrenheit (F) for 5 minutes. Each study participant will
      score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises
      during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. The
      5 minute heating temperature will be determined according to the subjects pain rating during
      the screening visit.

      The main goal of the study is to determine the effect of oxytocin during and after a fixed
      rate intravenous infusion on reduction in pain to a sustained heat stimulus in order to
      generate a model for peripheral analgesia.
In this study healthy people or those with knee arthritis so severe that they may need joint
      replacement are recruited for a one day study. Study participants will come to the Clinical
      Research Unit (CRU) and one intravenous (IV) catheter will be inserted in the forearm for
      oxytocin infusion. Participants in this study will receive oxytocin at a steady rate for 30
      minutes. This information will be analyzed by another group at Stanford University in the
      Pharmacokinetic/Pharmacodynamic (PK/PD) Core part of this application. Mathematics will be
      utilized to calculate how quickly oxytocin moves from the blood to where it reduces pain.

      Investigators will also do a pain test to determine how much oxytocin reduces pain. For this
      Investigators will place a probe on the skin and heat it to 113 - 117 degrees for 5 minutes.
      Study participants will score any pain they feel on a 0 to 10 scale, and most people find
      that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0
      to 10 scale.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group Oxytocin infusion
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 3 minutes prior to Oxytocin infusion
description: 3 Minutes prior to the Oxytocin infusion Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 12 minutes after the start of Oxytocin infusion
description: 12 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 27 minutes after the start of Oxytocin infusion
description: 27 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 42 minutes after the start of Oxytocin infusion
description: 42 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 57 minutes after the start of Oxytocin infusion
description: 57 Minutes after the Oxytocin infusion is initiated Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: Beginning of the Oxytocin infusion
description: Simultaneously with the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 15 minutes after the start of Oxytocin infusion
description: 15 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 30 minutes after the start of Oxytocin infusion
description: 30 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 45 minutes after the start of Oxytocin infusion
description: 45 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 60 minutes after the start of Oxytocin infusion
description: 60 minutes after the initiation of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 2 minutes after the beginning of the Oxytocin infusion
description: 2 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 17 minutes after the beginning of the Oxytocin infusion
description: 17 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 32 minutes after the beginning of the Oxytocin infusion
description: 32 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 47 minutes after the beginning of the Oxytocin infusion
description: 47 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 62 minutes after the beginning of the Oxytocin infusion
description: 62 minutes after initiation of Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 5 minutes after the beginning of the Oxytocin infusion
description: 5 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 20 minutes after the beginning of the Oxytocin infusion
description: 20 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 35 minutes after the beginning of the Oxytocin infusion
description: 35 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 50 minutes after the beginning of the Oxytocin infusion
description: 50 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 65 minutes after the beginning of the Oxytocin infusion
description: 65 minutes after the beginning of the Oxytocin infusion; Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C will be determined before, during and after infusions in order to create a PD model and validate the PK/PD model. Pain at the end of 5 minutes of heating the skin to 45 degrees C will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
arm group label: Oxytocin
arm group type: Experimental
description: Oxytocin administered by IV infusion
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin administered by IV infusion
arm group label: Oxytocin
other name: Pitocin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James C Eisenach, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Regina Curry, RN
phone: 336-716-4294
email: RECURRY@WAKEHEALTH.EDU
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Oxytocin