<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/NCT01673087</url>
  </required_header>
  <id_info>
    <org_study_id>1R01MH093486-01A1</org_study_id>
    <nct_id>NCT01673087</nct_id>
  </id_info>
  <brief_title>Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures</brief_title>
  <official_title>Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient&#xD;
      way to evaluate the biological impact of day-to-day stressors that people encounter as they&#xD;
      go about their lives, since saliva is so easy to collect. However, the biological meaning of&#xD;
      saliva cortisol measures has never been carefully examined. The goal of this study is to&#xD;
      collect saliva from a large group of people as they go about their every-day lives, to&#xD;
      measure their cortisol levels, and then study them in the laboratory where Investigators can&#xD;
      learn more about how their stress response system (which produces cortisol) is really&#xD;
      functioning. Investigators can then determine much more precisely what saliva cortisol levels&#xD;
      really mean in terms of stress system biology. This will allow investigators to obtain much&#xD;
      more useful information from the next decade of research on naturalistic stress and its&#xD;
      biological impact using saliva cortisol measures, helping investigators to understand how&#xD;
      stress undermines health and how to combat this effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 15, 2017</completion_date>
  <primary_completion_date type="Actual">August 15, 2017</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cortisol levels</measure>
    <time_frame>Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later</time_frame>
    <description>cortisol measured in saliva and in blood.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>corticotropin (ACTH)</measure>
    <time_frame>Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later</time_frame>
    <description>ACTH will be measured in blood using chemoluminescence detection.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>laboratory HPA probes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be studied with multiple probes of HPA axis function over the course of one to two months:&#xD;
Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metyrapone</intervention_name>
    <description>750 mcg, oral, administered twice, 3.5 hours apart</description>
    <arm_group_label>laboratory HPA probes</arm_group_label>
    <other_name>Metopirone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Administered twice:&#xD;
1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.</description>
    <arm_group_label>laboratory HPA probes</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cortrosyn</intervention_name>
    <description>250 mcg, IV, bolus, in the afternoon.</description>
    <arm_group_label>laboratory HPA probes</arm_group_label>
    <other_name>Cosyntropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticorelin ovine triflutate</intervention_name>
    <description>100 mcg, IV, over 30 seconds, in the afternoon.</description>
    <arm_group_label>laboratory HPA probes</arm_group_label>
    <other_name>Acthrel</other_name>
    <other_name>Corticotropin-Releasing Hormone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically healthy volunteers, ages 18 to 50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Irregular menses, medications or drugs that effect HPA axis&#xD;
&#xD;
          -  Most psychiatric disorders&#xD;
&#xD;
          -  Medical problems that effect HPA axis or increase risks involved in participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James L Abelson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>James Abelson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>stress biology</keyword>
  <keyword>cortisol</keyword>
  <keyword>adrenocorticotropin</keyword>
  <keyword>salivary biomarkers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Adrenocorticotropic Hormone</mesh_term>
    <mesh_term>Cosyntropin</mesh_term>
    <mesh_term>Corticotropin-Releasing Hormone</mesh_term>
    <mesh_term>Metyrapone</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/NCT01673087
org study id: 1R01MH093486-01A1
nct id: NCT01673087
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient
      way to evaluate the biological impact of day-to-day stressors that people encounter as they
      go about their lives, since saliva is so easy to collect. However, the biological meaning of
      saliva cortisol measures has never been carefully examined. The goal of this study is to
      collect saliva from a large group of people as they go about their every-day lives, to
      measure their cortisol levels, and then study them in the laboratory where Investigators can
      learn more about how their stress response system (which produces cortisol) is really
      functioning. Investigators can then determine much more precisely what saliva cortisol levels
      really mean in terms of stress system biology. This will allow investigators to obtain much
      more useful information from the next decade of research on naturalistic stress and its
      biological impact using saliva cortisol measures, helping investigators to understand how
      stress undermines health and how to combat this effect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: cortisol levels
time frame: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later
description: cortisol measured in saliva and in blood.
measure: corticotropin (ACTH)
time frame: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later
description: ACTH will be measured in blood using chemoluminescence detection.
arm group label: laboratory HPA probes
arm group type: Experimental
description: All subjects will be studied with multiple probes of HPA axis function over the course of one to two months:
Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus.
intervention type: Drug
intervention name: Metyrapone
description: 750 mcg, oral, administered twice, 3.5 hours apart
arm group label: laboratory HPA probes
other name: Metopirone
intervention type: Drug
intervention name: Dexamethasone
description: Administered twice:
1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.
arm group label: laboratory HPA probes
other name: Decadron
intervention type: Drug
intervention name: Cortrosyn
description: 250 mcg, IV, bolus, in the afternoon.
arm group label: laboratory HPA probes
other name: Cosyntropin
intervention type: Drug
intervention name: Corticorelin ovine triflutate
description: 100 mcg, IV, over 30 seconds, in the afternoon.
arm group label: laboratory HPA probes
other name: Acthrel
other name: Corticotropin-Releasing Hormone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James L Abelson, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: James Abelson
investigator title: Professor
mesh term: Dexamethasone
mesh term: Adrenocorticotropic Hormone
mesh term: Cosyntropin
mesh term: Corticotropin-Releasing Hormone
mesh term: Metyrapone