<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/NCT02979327</url>
  </required_header>
  <id_info>
    <org_study_id>16-004743</org_study_id>
    <nct_id>NCT02979327</nct_id>
  </id_info>
  <brief_title>Cardiovascular Effects of Adderall in Healthy Adults.</brief_title>
  <official_title>Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      This study is designed to investigate the cardiovascular response (blood pressure, heart&#xD;
      rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall&#xD;
      in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">July 23, 2021</completion_date>
  <primary_completion_date type="Actual">July 23, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Baseline; 3 hours after intake of active drug/placebo drug</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>Baseline; 3 hours after intake of active drug/placebo drug</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma catecholamines</measure>
    <time_frame>Baseline; 3 hours after intake of active drug/placebo drug</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hemodynamics</condition>
  <condition>Cardiovascular System</condition>
  <arm_group>
    <arm_group_label>Adderall first, then Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo first, then Adderall</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adderall capsule</intervention_name>
    <description>Amphetamine</description>
    <arm_group_label>Adderall first, then Placebo</arm_group_label>
    <arm_group_label>Placebo first, then Adderall</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <description>Placebo capsule</description>
    <arm_group_label>Adderall first, then Placebo</arm_group_label>
    <arm_group_label>Placebo first, then Adderall</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years of age and older&#xD;
&#xD;
          2. Healthy subjects without known cardiovascular disease, thyroid disease or documented&#xD;
             mental health illness&#xD;
&#xD;
          3. Subjects who are on no medications&#xD;
&#xD;
          4. Subjects with no prior history of regular amphetamine use, and non-prescription&#xD;
             stimulants&#xD;
&#xD;
          5. Nonsmokers&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subjects with known cardiovascular disease, thyroid disease&#xD;
&#xD;
          2. Subjects with history of psychotic disorders/mental health illness, including but not&#xD;
             limited to anxiety, depression, bipolar disorder; history of substance abuse or&#xD;
             dependence&#xD;
&#xD;
          3. Subjects currently taking medications&#xD;
&#xD;
          4. Prior history of regular amphetamine use, or non-prescription stimulants&#xD;
&#xD;
          5. Smokers&#xD;
&#xD;
          6. Pregnant subjects&#xD;
&#xD;
          7. Known lactose intolerance (due to presence of lactose in the prepared medication)&#xD;
&#xD;
          8. Family history of sudden cardiac death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Svatikova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Anna Svatikova</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adderall</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/NCT02979327
org study id: 16-004743
nct id: NCT02979327
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to investigate the cardiovascular response (blood pressure, heart
      rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall
      in healthy adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change in blood pressure
time frame: Baseline; 3 hours after intake of active drug/placebo drug
measure: Change in heart rate
time frame: Baseline; 3 hours after intake of active drug/placebo drug
measure: Change in plasma catecholamines
time frame: Baseline; 3 hours after intake of active drug/placebo drug
arm group label: Adderall first, then Placebo
arm group type: Experimental
description: Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.
arm group label: Placebo first, then Adderall
arm group type: Experimental
description: Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.
intervention type: Drug
intervention name: Adderall capsule
description: Amphetamine
arm group label: Adderall first, then Placebo
arm group label: Placebo first, then Adderall
intervention type: Drug
intervention name: Placebo capsule
description: Placebo capsule
arm group label: Adderall first, then Placebo
arm group label: Placebo first, then Adderall
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Svatikova, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Anna Svatikova
investigator title: Principal Investigator
mesh term: Adderall
sharing ipd: No