<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/NCT03810703</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-1293</org_study_id>
    <nct_id>NCT03810703</nct_id>
  </id_info>
  <brief_title>Differential Responses to Drugs and Sweet Tastes</brief_title>
  <acronym>HAP</acronym>
  <official_title>Hypomania, Amphetamine, and Preferences for Sweets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Young adults who exhibit &quot;bipolar phenotype&quot; (BPP), defined as occasional episodes of mood&#xD;
      elevation and heightened activity, are at risk for several psychiatric disorders, including&#xD;
      problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol&#xD;
      consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence&#xD;
      of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major&#xD;
      depression and schizophrenia. Recently, the investigators demonstrated in a controlled&#xD;
      laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I&#xD;
      Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the&#xD;
      current study, the investigators seek to extend these findings to determine if young adults&#xD;
      reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding&#xD;
      stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP&#xD;
      individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards&#xD;
      compared to healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will extend the understanding of risk factors for drug or alcohol misuse, or other&#xD;
      reward-related behaviors. The investigators previously showed that individuals who report&#xD;
      occasional feelings of high energy and excitability experience less effect from a single dose&#xD;
      of alcohol, compared to people who have not experienced these effects. Now the investigators&#xD;
      wish to determine if this dampened response also occurs with other rewards, namely feelings&#xD;
      of wellbeing after a dose of amphetamine, or liking of a sweet solution. Individuals who&#xD;
      exhibit the BPP (i.e., periods of excitability) also are more likely to develop alcohol&#xD;
      problems, substance misuse, and weight gain and obesity. Therefore, the investigators will&#xD;
      test the working hypothesis that young adults who report having these experiences, based on a&#xD;
      questionnaire measure (i.e., BPP individuals) will show dampened subjective responses to both&#xD;
      single oral doses of amphetamine or sweet palatable tastes. The investigators will also&#xD;
      obtain objective measures (e.g. Respiratory Sinus Arrhythmia and heart rate) to amphetamine&#xD;
      and sweet taste, to establish whether the dampened subjective response extends to&#xD;
      physiological indices as well. This study will extend the previous literature regarding the&#xD;
      blunted effects of alcohol in BPP individuals and will suggest possible mechanisms that&#xD;
      promote broader addictive behaviors in individuals with mood disturbance. Importantly, the&#xD;
      investigators are proposing to test individuals at a relatively young age, 18-19 years. This&#xD;
      is important to identify a risk factor, that is thought to pre-date use of drugs. In older&#xD;
      participants, it would be difficult to separate the role of the pre-existing trait from the&#xD;
      effect of habitual drug or alcohol use that escalates markedly after age 20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">August 9, 2018</completion_date>
  <primary_completion_date type="Actual">August 9, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Sub-scales of Drug Effects Questionnaire (DEQ).</measure>
    <time_frame>End of study (Baseline - time 0 and approximately 4 weeks later)</time_frame>
    <description>Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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;. All sub-scales 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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Bipolar II Disorder</condition>
  <arm_group>
    <arm_group_label>placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant will receive placebo oral capsule during this four hour session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amphetamine 10 mg arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amphetamine 20 mg arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo oral capsule</description>
    <arm_group_label>placebo arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>d-amphetamine 10 mg oral capsule</intervention_name>
    <description>d-amphetamine 10 mg oral capsule</description>
    <arm_group_label>amphetamine 10 mg arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>d-amphetamine 20 mg oral capsule</intervention_name>
    <description>d-amphetamine 20 mg oral capsule</description>
    <arm_group_label>amphetamine 20 mg arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-19 years old&#xD;
&#xD;
          -  BMI of 19-26&#xD;
&#xD;
          -  Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine&#xD;
&#xD;
          -  at least High School education&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No Current Mood, Anxiety, Eating or Psychotic Disorder&#xD;
&#xD;
          -  No current psychotropic medication&#xD;
&#xD;
          -  No Recent Drug Dependence&#xD;
&#xD;
          -  &lt; 4 alcoholic drinks/day for males; &lt; 3 alcoholic drinks/day for females (monthly&#xD;
             average)&#xD;
&#xD;
          -  No weekly (or more frequent) illicit drug use&#xD;
&#xD;
          -  No women who are pregnant, nursing, or planning pregnancy within 3 months (birth&#xD;
             control is okay)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Chicago Medical Center - Human Behavioral Pharmacology Lab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</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>
  <reference>
    <citation>Calabrese JR, Hirschfeld RM, Reed M, Davies MA, Frye MA, Keck PE, Lewis L, McElroy SL, McNulty JP, Wagner KD. Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry. 2003 Apr;64(4):425-32. doi: 10.4088/jcp.v64n0412.</citation>
    <PMID>12716245</PMID>
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    <citation>Hoeppner BB, Stout RL, Jackson KM, Barnett NP. How good is fine-grained Timeline Follow-back data? Comparing 30-day TLFB and repeated 7-day TLFB alcohol consumption reports on the person and daily level. Addict Behav. 2010 Dec;35(12):1138-43. doi: 10.1016/j.addbeh.2010.08.013. Epub 2010 Aug 13.</citation>
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    <citation>Hirschfeld RM, Holzer C, Calabrese JR, Weissman M, Reed M, Davies M, Frye MA, Keck P, McElroy S, Lewis L, Tierce J, Wagner KD, Hazard E. Validity of the mood disorder questionnaire: a general population study. Am J Psychiatry. 2003 Jan;160(1):178-80. doi: 10.1176/appi.ajp.160.1.178.</citation>
    <PMID>12505821</PMID>
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    <citation>Waleeprakhon P, Ittasakul P, Lotrakul M, Wisajun P, Jullagate S, Ketter TA. Development and validation of a screening instrument for bipolar spectrum disorder: The Mood Disorder Questionnaire Thai version. Neuropsychiatr Dis Treat. 2014 Aug 18;10:1497-502. doi: 10.2147/NDT.S67842. eCollection 2014.</citation>
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    <citation>Jacob T, Seilhamer RA, Bargeil K, Howell DN. Reliability of Lifetime Drinking History among alcohol dependent men. Psychol Addict Behav. 2006 Sep;20(3):333-7. doi: 10.1037/0893-164X.20.3.333.</citation>
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  <reference>
    <citation>Johanson CE, Uhlenhuth EH. Drug preference and mood in humans: d-amphetamine. Psychopharmacology (Berl). 1980;71(3):275-9. doi: 10.1007/BF00433062.</citation>
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    <citation>Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.</citation>
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    <citation>Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA. 1990 Nov 21;264(19):2511-8.</citation>
    <PMID>2232018</PMID>
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    <citation>Rock PL, Goodwin GM, Harmer CJ. The common adolescent bipolar phenotype shows positive biases in emotional processing. Bipolar Disord. 2010 Sep;12(6):606-15. doi: 10.1111/j.1399-5618.2010.00859.x.</citation>
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    <citation>Trost S, Diekhof EK, Mohr H, Vieker H, Kramer B, Wolf C, Keil M, Dechent P, Binder EB, Gruber O. Investigating the Impact of a Genome-Wide Supported Bipolar Risk Variant of MAD1L1 on the Human Reward System. Neuropsychopharmacology. 2016 Oct;41(11):2679-87. doi: 10.1038/npp.2016.70. Epub 2016 May 13.</citation>
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    <citation>Weafer J, Burkhardt A, de Wit H. Sweet taste liking is associated with impulsive behaviors in humans. Front Behav Neurosci. 2014 Jun 17;8:228. doi: 10.3389/fnbeh.2014.00228. eCollection 2014.</citation>
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    <citation>Gontkovsky ST. Sensitivity of the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-II) to the neurocognitive deficits associated with the semantic dementia variant of frontotemporal lobar degeneration: A case study. Appl Neuropsychol Adult. 2017 May-Jun;24(3):288-293. doi: 10.1080/23279095.2016.1154857. Epub 2016 Apr 21.</citation>
    <PMID>27101084</PMID>
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    <citation>White TL, Justice AJ, de Wit H. Differential subjective effects of D-amphetamine by gender, hormone levels and menstrual cycle phase. Pharmacol Biochem Behav. 2002 Nov;73(4):729-41. doi: 10.1016/s0091-3057(02)00818-3.</citation>
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    <citation>Yip SW, Doherty J, Wakeley J, Saunders K, Tzagarakis C, de Wit H, Goodwin GM, Rogers RD. Reduced subjective response to acute ethanol administration among young men with a broad bipolar phenotype. Neuropsychopharmacology. 2012 Jul;37(8):1808-15. doi: 10.1038/npp.2012.45. Epub 2012 Apr 11.</citation>
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  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>May 19, 2022</results_first_submitted>
  <results_first_submitted_qc>May 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 22, 2023</results_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amphetamine</mesh_term>
    <mesh_term>Dextroamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03810703/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Arm</title>
          <description>Participant will receive placebo oral capsule during this four hour session.&#xD;
Placebo oral capsule: Placebo oral capsule</description>
        </group>
        <group group_id="P2">
          <title>Amphetamine 10 mg Arm</title>
          <description>Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.&#xD;
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule</description>
        </group>
        <group group_id="P3">
          <title>Amphetamine 20 mg Arm</title>
          <description>Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.&#xD;
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="31"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Arm</title>
          <description>Participant will receive placebo oral capsule during this four hour session.&#xD;
Placebo oral capsule: Placebo oral capsule</description>
        </group>
        <group group_id="B2">
          <title>Amphetamine 10 mg Arm</title>
          <description>Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.&#xD;
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule</description>
        </group>
        <group group_id="B3">
          <title>Amphetamine 20 mg Arm</title>
          <description>Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.&#xD;
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule</description>
        </group>
        <group group_id="B4">
          <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="31"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="93"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education - High School Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Sub-scales of Drug Effects Questionnaire (DEQ).</title>
        <description>Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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;. All sub-scales 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.</description>
        <time_frame>End of study (Baseline - time 0 and approximately 4 weeks later)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Arm</title>
            <description>Participant will receive placebo oral capsule during this four hour session.&#xD;
Placebo oral capsule: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>Amphetamine 10 mg Arm</title>
            <description>Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.&#xD;
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule</description>
          </group>
          <group group_id="O3">
            <title>Amphetamine 20 mg Arm</title>
            <description>Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.&#xD;
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Effects as Assessed by Score on &quot;Feel Drug&quot;, &quot;Feel High&quot;, &quot;Like Drug&quot;, and &quot;Want More&quot; Sub-scales of Drug Effects Questionnaire (DEQ).</title>
          <description>Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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;. All sub-scales 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.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Feel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.88" spread="8.84"/>
                    <measurement group_id="O2" value="35.25" spread="4.46"/>
                    <measurement group_id="O3" value="45.75" spread="8.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.44" spread="7.64"/>
                    <measurement group_id="O2" value="50.69" spread="7.82"/>
                    <measurement group_id="O3" value="52.81" spread="8.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dislike</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.00" spread="5.96"/>
                    <measurement group_id="O2" value="27.19" spread="6.47"/>
                    <measurement group_id="O3" value="16.25" spread="5.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.50" spread="5.50"/>
                    <measurement group_id="O2" value="24.88" spread="5.48"/>
                    <measurement group_id="O3" value="32.69" spread="8.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.19" spread="7.56"/>
                    <measurement group_id="O2" value="45.38" spread="7.66"/>
                    <measurement group_id="O3" value="52.44" spread="8.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 5 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Arm</title>
          <description>Participant will receive placebo oral capsule during this four hour session.&#xD;
Placebo oral capsule: Placebo oral capsule</description>
        </group>
        <group group_id="E2">
          <title>Amphetamine 10 mg Arm</title>
          <description>Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.&#xD;
d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule</description>
        </group>
        <group group_id="E3">
          <title>Amphetamine 20 mg Arm</title>
          <description>Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.&#xD;
d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </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>Dave Arndt</name_or_title>
      <organization>University of Chicago</organization>
      <phone>7737023560</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/NCT03810703
org study id: IRB16-1293
nct id: NCT03810703
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood
      elevation and heightened activity, are at risk for several psychiatric disorders, including
      problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol
      consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence
      of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major
      depression and schizophrenia. Recently, the investigators demonstrated in a controlled
      laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I
      Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the
      current study, the investigators seek to extend these findings to determine if young adults
      reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding
      stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP
      individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards
      compared to healthy controls.
This study will extend the understanding of risk factors for drug or alcohol misuse, or other
      reward-related behaviors. The investigators previously showed that individuals who report
      occasional feelings of high energy and excitability experience less effect from a single dose
      of alcohol, compared to people who have not experienced these effects. Now the investigators
      wish to determine if this dampened response also occurs with other rewards, namely feelings
      of wellbeing after a dose of amphetamine, or liking of a sweet solution. Individuals who
      exhibit the BPP (i.e., periods of excitability) also are more likely to develop alcohol
      problems, substance misuse, and weight gain and obesity. Therefore, the investigators will
      test the working hypothesis that young adults who report having these experiences, based on a
      questionnaire measure (i.e., BPP individuals) will show dampened subjective responses to both
      single oral doses of amphetamine or sweet palatable tastes. The investigators will also
      obtain objective measures (e.g. Respiratory Sinus Arrhythmia and heart rate) to amphetamine
      and sweet taste, to establish whether the dampened subjective response extends to
      physiological indices as well. This study will extend the previous literature regarding the
      blunted effects of alcohol in BPP individuals and will suggest possible mechanisms that
      promote broader addictive behaviors in individuals with mood disturbance. Importantly, the
      investigators are proposing to test individuals at a relatively young age, 18-19 years. This
      is important to identify a risk factor, that is thought to pre-date use of drugs. In older
      participants, it would be difficult to separate the role of the pre-existing trait from the
      effect of habitual drug or alcohol use that escalates markedly after age 20.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
time frame: End of study (Baseline - time 0 and approximately 4 weeks later)
description: Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug 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". All sub-scales 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.
arm group label: placebo arm
arm group type: Placebo Comparator
description: Participant will receive placebo oral capsule during this four hour session.
arm group label: amphetamine 10 mg arm
arm group type: Experimental
description: Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
arm group label: amphetamine 20 mg arm
arm group type: Experimental
description: Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo oral capsule
arm group label: placebo arm
intervention type: Drug
intervention name: d-amphetamine 10 mg oral capsule
description: d-amphetamine 10 mg oral capsule
arm group label: amphetamine 10 mg arm
intervention type: Drug
intervention name: d-amphetamine 20 mg oral capsule
description: d-amphetamine 20 mg oral capsule
arm group label: amphetamine 20 mg arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
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PMID: 17081672
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PMID: 20822852
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PMID: 22491350
responsible party type: Sponsor
mesh term: Amphetamine
mesh term: Dextroamphetamine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 