<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/NCT04429880</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00065787</org_study_id>
    <nct_id>NCT04429880</nct_id>
  </id_info>
  <brief_title>A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects</brief_title>
  <official_title>A Study of Oxytocin Pharmacokinetics After Intravenous Administration in Healthy Subjects and Advanced Knee Arthritis Subjects</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>
      The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK)&#xD;
      of oxytocin.&#xD;
&#xD;
      This is an unblinded, sequential study of subjects, all of whom will receive an intravenous&#xD;
      (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood&#xD;
      samples taken thereafter in order to create a formula to describe the concentrations of&#xD;
      oxytocin in the blood over time (pharmacokinetics).&#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 2 IV&#xD;
      catheters placed (one in each arm). After placement of the IV catheters and infusion of&#xD;
      oxytocin will be given over a 10 minute period. Blood samples will be taken before the&#xD;
      infusion begins and several times during and after the infusion. The blood will be drawn&#xD;
      through the second IV catheter.&#xD;
&#xD;
      The investigators will also do some tests to get a rough idea of how oxytocin changes&#xD;
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the&#xD;
      same time. Two kinds of perceptions will be studied. First, the investigators will study a&#xD;
      painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit&#xD;
      for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10&#xD;
      scale, and most people find that pain rises during the 5 minutes, but remains mild, usually&#xD;
      around only 1 or 2 on the 0 to 10 scale. Secondly, the investigators will study the&#xD;
      perception of vibration, like one feels with a tuning fork on the skin. For this the&#xD;
      investigators will put a controlled vibration device on the arm and start the vibration at&#xD;
      such a high frequency (1000 times per second) that it cannot be felt as vibrating. The&#xD;
      investigators will slow the frequency until the study participant first feels vibration, then&#xD;
      turn off the machine and record this threshold frequency where it is first felt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an unblinded, sequential study of subjects; all participants will receive an infusion&#xD;
      of oxytocin with blood samples taken thereafter in order to create a formula to describe the&#xD;
      concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy&#xD;
      volunteers and people with knee arthritis so severe that they may need joint replacement are&#xD;
      recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and&#xD;
      have two IVs inserted; one in each arm. Participants will get a 10 minute infusion through&#xD;
      one of the IVs of oxytocin and blood will be taken several times over the next 120 minutes&#xD;
      and the amount of oxytocin measured in the blood samples. This information will be analyzed&#xD;
      by another group at Stanford University in the Pharmacokinetics/Pharmacodynamics (PK/PD) Core&#xD;
      part of this application. Mathematics will be utilized to fit the amount of oxytocin over&#xD;
      time as it disappears from blood to a formula, called pharmacokinetics. The effect of subject&#xD;
      age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be tested for,&#xD;
      since these things can affect how quickly drugs circulate in the blood and are important to&#xD;
      better adjust the dose of drug to the individual.&#xD;
&#xD;
      The main purpose of this study is to sample the blood and calculate the pharmacokinetics of&#xD;
      oxytocin. Investigators will also do some tests to get a rough idea of how oxytocin changes&#xD;
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the&#xD;
      same time. Two kinds of perceptions will be studied. In the first the study team will study a&#xD;
      painful perception by placing a probe on the skin and heating it to 113 degrees F for 5&#xD;
      minutes. Subjects will score any pain felt on a 0 to 10 scale, and most people find that pain&#xD;
      rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10&#xD;
      scale. In the second, the study team will study the perception of vibration, like one feels&#xD;
      with a tuning fork on the skin. For this the study team will put a controlled vibration&#xD;
      device on the arm and start the vibration at such a high frequency (1000 times per second)&#xD;
      that it cannot be felt as vibrating. The study team will slow the frequency until the subject&#xD;
      first feels vibration, then turn off the machine and record this threshold frequency where&#xD;
      the participant first feels it. Investigators do these two tests because they test the&#xD;
      response of two kinds of nerve fibers - pain fibers and touch fibers - which oxytocin might&#xD;
      affect in different ways. With this information investigators will compare the amount of&#xD;
      oxytocin in blood over time to its effects on pain and vibration over time using mathematics.&#xD;
&#xD;
      The research participants will not benefit from this study, but the knowledge investigators&#xD;
      get will be important not only to adjust oxytocin dose to individuals, but to study its&#xD;
      possible effects on pain in a very standardized way. The sample size chosen is needed to get&#xD;
      an accurate estimate for the parameters in the pharmacokinetic model for the population, not&#xD;
      just the subjects in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not initiated; no subjects enrolled. A replacement study will be submitted&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2023</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 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>Each participant will receive the same dose of oxytocin 17 micrograms via a 10 minute intravenous infusion</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>1 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>2 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>5 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>10 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>12 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>15 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>20 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>30 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>60 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>90 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum</measure>
    <time_frame>120 minute after oxytocin infusion initiated</time_frame>
    <description>Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>30 minutes after oxytocin infusion initiated</time_frame>
    <description>Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>60 minutes after oxytocin infusion initiated</time_frame>
    <description>Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined,pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>90 minutes after oxytocin infusion initiated</time_frame>
    <description>Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>120 minutes after oxytocin infusion initiated</time_frame>
    <description>Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>180 minutes after oxytocin infusion initiated</time_frame>
    <description>Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of vibration perception after oxytocin</measure>
    <time_frame>30 minutes after oxytocin infusion initiated</time_frame>
    <description>Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.&#xD;
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of vibration perception after oxytocin</measure>
    <time_frame>60 minutes after oxytocin infusion initiated</time_frame>
    <description>Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.&#xD;
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of vibration perception after oxytocin</measure>
    <time_frame>90 minutes after oxytocin infusion initiated</time_frame>
    <description>Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.&#xD;
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of vibration perception after oxytocin</measure>
    <time_frame>120 minutes after oxytocin infusion initiated</time_frame>
    <description>Threshold frequency for detection of vibration will be determined. Verbal report on detection of vibration.&#xD;
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of vibration perception after oxytocin</measure>
    <time_frame>180 minutes after oxytocin infusion initiated</time_frame>
    <description>Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.&#xD;
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin 17 micrograms infusion over 10 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin given by intravenous route</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&#xD;
             50-90 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&#xD;
             be practicing highly effective methods of birth control such as hormonal methods&#xD;
             (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double&#xD;
             barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal&#xD;
             jellies or cream), or total abstinence from heterosexual intercourse for a minimum of&#xD;
             1 full 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&#xD;
             the Principal Investigator, would place the subject at increased risk (active&#xD;
             gynecologic disease in which increased tone would be detrimental e.g., uterine&#xD;
             fibroids with ongoing bleeding), compromise the subject's compliance with study&#xD;
             procedures, or compromise the quality of the data&#xD;
&#xD;
          -  3. Women who are pregnant (positive result for serum pregnancy test at screening&#xD;
             visit), women who are currently nursing or lactating, women that have been pregnant&#xD;
             within 2 years&#xD;
&#xD;
          -  4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking&#xD;
             benzodiazepines or pain medications on a daily basis.&#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>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04429880
org study id: IRB00065787
nct id: NCT04429880
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK)
      of oxytocin.

      This is an unblinded, sequential study of subjects, all of whom will receive an intravenous
      (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood
      samples taken thereafter in order to create a formula to describe the concentrations of
      oxytocin in the blood over time (pharmacokinetics).

      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 2 IV
      catheters placed (one in each arm). After placement of the IV catheters and infusion of
      oxytocin will be given over a 10 minute period. Blood samples will be taken before the
      infusion begins and several times during and after the infusion. The blood will be drawn
      through the second IV catheter.

      The investigators will also do some tests to get a rough idea of how oxytocin changes
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the
      same time. Two kinds of perceptions will be studied. First, the investigators will study a
      painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit
      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. Secondly, the investigators will study the
      perception of vibration, like one feels with a tuning fork on the skin. For this the
      investigators will put a controlled vibration device on the arm and start the vibration at
      such a high frequency (1000 times per second) that it cannot be felt as vibrating. The
      investigators will slow the frequency until the study participant first feels vibration, then
      turn off the machine and record this threshold frequency where it is first felt.
This is an unblinded, sequential study of subjects; all participants will receive an infusion
      of oxytocin with blood samples taken thereafter in order to create a formula to describe the
      concentrations of oxytocin in the blood over time (pharmacokinetics). 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. Participants will come to the Clinical Research Unit (CRU) and
      have two IVs inserted; one in each arm. Participants will get a 10 minute infusion through
      one of the IVs of oxytocin and blood will be taken several times over the next 120 minutes
      and the amount of oxytocin measured in the blood samples. This information will be analyzed
      by another group at Stanford University in the Pharmacokinetics/Pharmacodynamics (PK/PD) Core
      part of this application. Mathematics will be utilized to fit the amount of oxytocin over
      time as it disappears from blood to a formula, called pharmacokinetics. The effect of subject
      age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be tested for,
      since these things can affect how quickly drugs circulate in the blood and are important to
      better adjust the dose of drug to the individual.

      The main purpose of this study is to sample the blood and calculate the pharmacokinetics of
      oxytocin. Investigators will also do some tests to get a rough idea of how oxytocin changes
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the
      same time. Two kinds of perceptions will be studied. In the first the study team will study a
      painful perception by placing a probe on the skin and heating it to 113 degrees F for 5
      minutes. Subjects will score any pain felt 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. In the second, the study team will study the perception of vibration, like one feels
      with a tuning fork on the skin. For this the study team will put a controlled vibration
      device on the arm and start the vibration at such a high frequency (1000 times per second)
      that it cannot be felt as vibrating. The study team will slow the frequency until the subject
      first feels vibration, then turn off the machine and record this threshold frequency where
      the participant first feels it. Investigators do these two tests because they test the
      response of two kinds of nerve fibers - pain fibers and touch fibers - which oxytocin might
      affect in different ways. With this information investigators will compare the amount of
      oxytocin in blood over time to its effects on pain and vibration over time using mathematics.

      The research participants will not benefit from this study, but the knowledge investigators
      get will be important not only to adjust oxytocin dose to individuals, but to study its
      possible effects on pain in a very standardized way. The sample size chosen is needed to get
      an accurate estimate for the parameters in the pharmacokinetic model for the population, not
      just the subjects in this study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each participant will receive the same dose of oxytocin 17 micrograms via a 10 minute intravenous infusion
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics of oxytocin in serum
time frame: 1 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 2 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 5 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 10 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 12 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 15 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 20 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 30 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 60 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 90 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacokinetics of oxytocin in serum
time frame: 120 minute after oxytocin infusion initiated
description: Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 30 minutes after oxytocin infusion initiated
description: Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 60 minutes after oxytocin infusion initiated
description: Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined,pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 90 minutes after oxytocin infusion initiated
description: Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 120 minutes after oxytocin infusion initiated
description: Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain after oxytocin
time frame: 180 minutes after oxytocin infusion initiated
description: Pain at the end of 5 minutes of heating the skin to 45 degrees Celsius will be determined, pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of vibration perception after oxytocin
time frame: 30 minutes after oxytocin infusion initiated
description: Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
measure: Pharmacodynamics of vibration perception after oxytocin
time frame: 60 minutes after oxytocin infusion initiated
description: Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
measure: Pharmacodynamics of vibration perception after oxytocin
time frame: 90 minutes after oxytocin infusion initiated
description: Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
measure: Pharmacodynamics of vibration perception after oxytocin
time frame: 120 minutes after oxytocin infusion initiated
description: Threshold frequency for detection of vibration will be determined. Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
measure: Pharmacodynamics of vibration perception after oxytocin
time frame: 180 minutes after oxytocin infusion initiated
description: Threshold frequency for detection of vibration will be determined.Verbal report on detection of vibration.
The threshold for first feeling vibration as the frequency of the stimulus is changed will be recorded for each subject. This is done by applying the probe to the skin and reducing frequency from 1000 Hz until the subject perceives the vibration. This is repeated 3 times and the average is taken as the value
arm group label: Oxytocin
arm group type: Experimental
description: Oxytocin 17 micrograms infusion over 10 minutes
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin given by intravenous route
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
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Oxytocin
sharing ipd: No