<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/NCT02205983</url>
  </required_header>
  <id_info>
    <org_study_id>UC13-1027</org_study_id>
    <secondary_id>R01DA002812</secondary_id>
    <nct_id>NCT02205983</nct_id>
  </id_info>
  <brief_title>The Effects of Hydromorphone on Responses to Verbal Tasks</brief_title>
  <acronym>HESS</acronym>
  <official_title>The Effects of Hydromorphone on Responses to Verbal Tasks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will examine the effects of hydromorphone, as compared to&#xD;
      placebo, upon physiological, subjective, and hormonal responses to a stressful speech task&#xD;
      and a non-stressful control task in healthy adults. There is strong evidence in support of&#xD;
      the role of endogenous opioids and opiates in mediating social behavior in humans and other&#xD;
      animals, and particularly, in social distress. The investigators have recently shown that&#xD;
      buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the&#xD;
      investigators propose to further explore the role of the opioid system in mediating stress&#xD;
      responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition&#xD;
      to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will&#xD;
      reduce both physiological and subjective measures of stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg&#xD;
      hydromorphone, or placebo at each of two sessions; one during which they well participate in&#xD;
      a stressful speaking task, and one during which they'll participate in a nonstressful control&#xD;
      task. Physiological and subjective measures will be taken throughout each session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Subscales of the Drug Effects Questionnaire</measure>
    <time_frame>End of study (time 0 and approximately 4 weeks later), week 4 reported.</time_frame>
    <description>The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot;. The &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>2 mg hydromophone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 mg hydromphone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1000 mg acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dextrose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy adult volunteers will recieve Dextrose (placebo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 mg hydromorphone</intervention_name>
    <description>We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
    <arm_group_label>2 mg hydromophone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1000 mg Acetaminophen</intervention_name>
    <description>We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.</description>
    <arm_group_label>1000 mg acetaminophen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4 mg hydromorphone</intervention_name>
    <description>We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
    <arm_group_label>4 mg hydromphone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dextrose</intervention_name>
    <description>We are administering dextrose to healthy volunteers for our placebo group.</description>
    <arm_group_label>Dextrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any current medical condition requiring medication or abnormal electrocardiogram&#xD;
&#xD;
          2. current or past medical condition considered to be a contraindication for the study&#xD;
             conditions&#xD;
&#xD;
          3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder,&#xD;
             or Anxiety Disorder or Major Depression in the past year, any history of psychosis&#xD;
&#xD;
          4. less than high school education&#xD;
&#xD;
          5. lack of fluency in English&#xD;
&#xD;
          6. night shift work&#xD;
&#xD;
          7. Pregnancy, lactation or plans to become pregnant.&#xD;
&#xD;
          8. Use of hormonal contraception.&#xD;
&#xD;
          9. Daily cigarette smokers i.e., &gt;7 cigarettes per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harriet de Wit, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jerome Jaffe, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Maryland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>June 1, 2018</results_first_submitted>
  <results_first_submitted_qc>September 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2018</results_first_posted>
  <last_update_submitted>September 10, 2018</last_update_submitted>
  <last_update_submitted_qc>September 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>enrolling</keyword>
  <keyword>adult</keyword>
  <keyword>volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were excluded if they had a serious medical condition, abnormal electrocardiogram, Axis I psychiatric disorder in the past year, or a history of psychosis. Subjects were also excluded if they had not completed high school, were not fluent in English, worked a night shift, used hormonal contraceptives, or were pregnant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>2 mg Hydromorphone</title>
        </group>
        <group group_id="P2">
          <title>4 mg Hydromorphone</title>
        </group>
        <group group_id="P3">
          <title>1000 mg Acetaminophen</title>
        </group>
        <group group_id="P4">
          <title>Dextrose (Placebo)</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>2 mg Hydromophone</title>
          <description>Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.</description>
        </group>
        <group group_id="B2">
          <title>4 mg Hydromorphone</title>
          <description>Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion</description>
        </group>
        <group group_id="B3">
          <title>1000 mg Acetaminophen</title>
          <description>Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.</description>
        </group>
        <group group_id="B4">
          <title>Dextrose (Placebo)</title>
          <description>Healthy adult volunteers will receive Dextrose (placebo).</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="13"/>
            <count group_id="B5" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.9" spread="1.8"/>
                    <measurement group_id="B2" value="21.2" spread="2.8"/>
                    <measurement group_id="B3" value="23.6" spread="6.6"/>
                    <measurement group_id="B4" value="23.1" spread="4.4"/>
                    <measurement group_id="B5" value="22" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Subscales of the Drug Effects Questionnaire</title>
        <description>The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot;. The &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4</description>
        <time_frame>End of study (time 0 and approximately 4 weeks later), week 4 reported.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 mg Hydromophone</title>
            <description>Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.&#xD;
2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
          </group>
          <group group_id="O2">
            <title>4 mg Hydromphone</title>
            <description>Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion&#xD;
4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
          </group>
          <group group_id="O3">
            <title>1000 mg Acetaminophen</title>
            <description>Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.&#xD;
1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.</description>
          </group>
          <group group_id="O4">
            <title>Dextrose</title>
            <description>Healthy adult volunteers will recieve Dextrose (placebo).&#xD;
dextrose: We are administering dextrose to healthy volunteers for our placebo group.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Subscales of the Drug Effects Questionnaire</title>
          <description>The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot;. The &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Feel Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.41" spread="1.2"/>
                    <measurement group_id="O2" value="14.75" spread="1.9"/>
                    <measurement group_id="O3" value="28" spread="1.5"/>
                    <measurement group_id="O4" value="5.76" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Like Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="1.8"/>
                    <measurement group_id="O2" value="35.58" spread="2.5"/>
                    <measurement group_id="O3" value="9.61" spread="2.2"/>
                    <measurement group_id="O4" value="4.15" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feel High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="1.5"/>
                    <measurement group_id="O2" value="10.33" spread="1.01"/>
                    <measurement group_id="O3" value="15" spread="1.8"/>
                    <measurement group_id="O4" value="2.61" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Want More</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="2.1"/>
                    <measurement group_id="O2" value="26.83" spread="1.5"/>
                    <measurement group_id="O3" value="7.38" spread="1.96"/>
                    <measurement group_id="O4" value="2.65" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>2 mg Hydromophone</title>
          <description>Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.&#xD;
2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
        </group>
        <group group_id="E2">
          <title>4 mg Hydromphone</title>
          <description>Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion&#xD;
4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.</description>
        </group>
        <group group_id="E3">
          <title>1000 mg Acetaminophen</title>
          <description>Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.&#xD;
1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.</description>
        </group>
        <group group_id="E4">
          <title>Dextrose</title>
          <description>Healthy adult volunteers will recieve Dextrose (placebo).&#xD;
dextrose: We are administering dextrose to healthy volunteers for our placebo group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Harriet de Wit</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-702-3560</phone>
      <email>dewitlab@yoda.bsd.uchicago.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02205983
org study id: UC13-1027
secondary id: R01DA002812
nct id: NCT02205983
lead sponsor: 
collaborator: 
has dmc: No
In this study, the investigators will examine the effects of hydromorphone, as compared to
      placebo, upon physiological, subjective, and hormonal responses to a stressful speech task
      and a non-stressful control task in healthy adults. There is strong evidence in support of
      the role of endogenous opioids and opiates in mediating social behavior in humans and other
      animals, and particularly, in social distress. The investigators have recently shown that
      buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the
      investigators propose to further explore the role of the opioid system in mediating stress
      responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition
      to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will
      reduce both physiological and subjective measures of stress.
Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg
      hydromorphone, or placebo at each of two sessions; one during which they well participate in
      a stressful speaking task, and one during which they'll participate in a nonstressful control
      task. Physiological and subjective measures will be taken throughout each session.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
time frame: End of study (time 0 and approximately 4 weeks later), week 4 reported.
description: The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4
arm group label: 2 mg hydromophone
arm group type: Experimental
description: Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.
arm group label: 4 mg hydromphone
arm group type: Experimental
description: Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion
arm group label: 1000 mg acetaminophen
arm group type: Experimental
description: Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.
arm group label: Dextrose
arm group type: Placebo Comparator
description: Healthy adult volunteers will recieve Dextrose (placebo).
intervention type: Drug
intervention name: 2 mg hydromorphone
description: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
arm group label: 2 mg hydromophone
intervention type: Drug
intervention name: 1000 mg Acetaminophen
description: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
arm group label: 1000 mg acetaminophen
intervention type: Drug
intervention name: 4 mg hydromorphone
description: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
arm group label: 4 mg hydromphone
intervention type: Drug
intervention name: dextrose
description: We are administering dextrose to healthy volunteers for our placebo group.
arm group label: Dextrose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harriet de Wit, PhD
role: Principal Investigator
affiliation: University of Chicago
last name: Jerome Jaffe, MD
role: Study Chair
affiliation: University of Maryland
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acetaminophen
mesh term: Hydromorphone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 