<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/NCT01699607</url>
  </required_header>
  <id_info>
    <org_study_id>0910005822</org_study_id>
    <secondary_id>R25MH071584</secondary_id>
    <secondary_id>1P50CA196530-01</secondary_id>
    <nct_id>NCT01699607</nct_id>
  </id_info>
  <brief_title>Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm</brief_title>
  <acronym>phno_amth</acronym>
  <official_title>Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A research study designed to examine amphetamine-induced dopamine release using the PET&#xD;
      imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute&#xD;
      withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy&#xD;
      nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 [11C]PHNO&#xD;
      PET scans. On the study day subjects will participate in two [11C]PHNO scans (ideally, the&#xD;
      two PET scans will be carried out in the same day). Three hours before the second PET scan,&#xD;
      amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will occur at 10-21&#xD;
      days of smoking abstinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine amphetamine-induced DA release in tobacco smokers while currently smoking and&#xD;
      during acute withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and&#xD;
      twenty healthy nonsmokers will be recruited. Each subject will participate in 1 MRI and up to&#xD;
      2 [11C]PHNO PET scans. On the PET study day subjects will participate in two [11C]PHNO scans&#xD;
      (ideally, the two PET scans will be carried out in the same day). Three hours before the&#xD;
      second PET scan, amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the set of&#xD;
      scans will occur at 10-21 days of smoking abstinence. Smoking abstinence will be determined&#xD;
      by carbon monoxide and urine cotinine (a breakdown product of nicotine in cigarette smoke)&#xD;
      levels. Subjects will be asked to breathe into a breathalyzer to measure carbon monoxide and&#xD;
      to provide a urine sample to measure cotinine. Smoking abstinence will be confirmed by carbon&#xD;
      monoxide and cotinine levels that are reduced as compared to actively smoking. We hypothesize&#xD;
      that smokers at 10-21 days of withdrawal will have amphetamine-induced DA release that is&#xD;
      blunted compared to healthy nonsmokers.&#xD;
&#xD;
      Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject to co-register&#xD;
      PET and MRI for image analysis. Within two weeks of the PET study, an MRI will be acquired at&#xD;
      the Yale University MRI Center. Subjects will be taken through a ferromagnetic metal detector&#xD;
      before entering the scan room. The acquisition sequence is a 3D fast spoiled grass (FSPGR) MR&#xD;
      pulse sequence with an IR prep of 300 ms. (TE= 3.3 ms, flip angle=17 degrees; slice&#xD;
      thickness= 1.2 mm) optimized for delineating gray matter/white matter/CSF boundaries. The&#xD;
      small voxel size (0.93 X 1.2 X 0.93 mm) provides high-resolution volumetric images. MR images&#xD;
      provide a matching anatomical atlas for creating individualized region-of-interest templates&#xD;
      for each subject.&#xD;
&#xD;
      Subject preparation consists of two intravenous (IV) catheterizations and immobilization of&#xD;
      the head. PET scans are acquired as subjects rest using an HRRT PET scanner (207 slices,&#xD;
      resolution better than 3 mm FWHM). This resolution permits visualization of the PHNO and&#xD;
      raclopride uptake in the ventral/dorsal striatum, in globus pallidus (GP) and substantia&#xD;
      nigra (SN). A transmission scan using an orbiting 137Cs point-source is obtained for each&#xD;
      emission scan. Motion correction will be performed dynamically with measurements from the&#xD;
      Vicra (NDI Systems, Waterloo, Ontario) used by a dedicated list-mode reconstruction&#xD;
      algorithm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.</measure>
    <time_frame>first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration</time_frame>
    <description>PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Nicotine Dependence</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>amphetamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There is only one arm to the study. All subjects will receive amphetamine at 0.5mg/kg prior to the second PET scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amphetamine</intervention_name>
    <description>All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg</description>
    <arm_group_label>amphetamine</arm_group_label>
    <other_name>dextro-amphetamine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women, aged 18-55 years&#xD;
&#xD;
          -  who are able to read and write&#xD;
&#xD;
          -  who are able to give voluntary written informed consent&#xD;
&#xD;
          -  have no current uncontrolled medical condition such as neurological, cardiovascular,&#xD;
             endocrine, renal, liver, or thyroid pathology&#xD;
&#xD;
          -  have no history of a neurological or psychiatric disorder, e.g., no DSMIV Axis 1&#xD;
             diagnosis in 2 preceding years, except nicotine dependence in smokers)&#xD;
&#xD;
          -  drink less than 21 drinks/week for women and less than 35 drinks per week for men&#xD;
&#xD;
          -  have not used marijuana in the past 30 days and have not met criteria for dependence&#xD;
             in the past 2 years&#xD;
&#xD;
          -  do not suffer from claustrophobia or any MRI contradictions&#xD;
&#xD;
          -  nonsmokers (smoked &lt; 40 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL&#xD;
             both at intake evaluation and on scan day)&#xD;
&#xD;
          -  smokers (smoked at least 10 cigarettes/day for at least one year with an FTND&gt;3, urine&#xD;
             cotinine &gt;150 ng/mL and CO &gt;12 ppm at intake)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  presence of acute or unstable medical or neurological illness. Subjects will be&#xD;
             excluded from the study if they present with any history of serious medical or&#xD;
             neurological illness or if they show signs of a major medical or neurological illness&#xD;
             on examination or lab testing including history of seizures, head injury, brain tumor,&#xD;
             heart, liver or kidney disease, eating disorder, diabetes.&#xD;
&#xD;
          -  regular use of any psychotropic drugs including anxiolytics and antidepressants and&#xD;
             other over-the-counter medications and herbal products within the last six months&#xD;
&#xD;
          -  pregnancy/breast feeding (as documented by pregnancy testing at screening or on days&#xD;
             of the imaging studies),&#xD;
&#xD;
          -  suicidal ideation or behavior&#xD;
&#xD;
          -  pacemaker or other ferromagnetic material in body.&#xD;
&#xD;
          -  use of medications which affect dopamine transmission within 2 weeks of the PET study&#xD;
&#xD;
          -  participation in other research studies involving ionizing radiation within one year&#xD;
             of the PET scans that would cause the subject to exceed the yearly dose limits for&#xD;
             normal volunteers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Cosgrove, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>July 14, 2015</results_first_submitted>
  <results_first_submitted_qc>August 18, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 18, 2015</results_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cigarette Smokers</keyword>
  <keyword>Healthy Non Smokers</keyword>
  <keyword>Amphetamine</keyword>
  <keyword>PET</keyword>
  <keyword>Controls</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cigarette Smokers</title>
          <description>Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.</description>
        </group>
        <group group_id="P2">
          <title>Nonsmoking Subjects</title>
          <description>Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cigarette Smokers</title>
          <description>Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.</description>
        </group>
        <group group_id="B2">
          <title>Nonsmoker Subjects</title>
          <description>Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.</description>
        </group>
        <group group_id="B3">
          <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="6"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="10"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </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_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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, not of Hispanic origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.</title>
        <description>PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.</description>
        <time_frame>first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Smoking Subjects</title>
            <description>Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.</description>
          </group>
          <group group_id="O2">
            <title>Nonsmoking Subjects</title>
            <description>Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.</title>
          <description>PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.</description>
          <units>percent change in binding potential</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21" spread="12.0"/>
                    <measurement group_id="O2" value="-29" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Amphetamine</title>
          <description>There is only one arm to the study. All subjects will receive amphetamine.&#xD;
Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>Preliminary data. Small subject number.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kelly Cosgrove, Ph.D.</name_or_title>
      <organization>Yale</organization>
      <phone>203-737-6969</phone>
      <email>kelly.cosgrove@yale.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/NCT01699607
org study id: 0910005822
secondary id: R25MH071584
secondary id: 1P50CA196530-01
nct id: NCT01699607
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A research study designed to examine amphetamine-induced dopamine release using the PET
      imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute
      withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy
      nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 [11C]PHNO
      PET scans. On the study day subjects will participate in two [11C]PHNO scans (ideally, the
      two PET scans will be carried out in the same day). Three hours before the second PET scan,
      amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will occur at 10-21
      days of smoking abstinence.
To determine amphetamine-induced DA release in tobacco smokers while currently smoking and
      during acute withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and
      twenty healthy nonsmokers will be recruited. Each subject will participate in 1 MRI and up to
      2 [11C]PHNO PET scans. On the PET study day subjects will participate in two [11C]PHNO scans
      (ideally, the two PET scans will be carried out in the same day). Three hours before the
      second PET scan, amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the set of
      scans will occur at 10-21 days of smoking abstinence. Smoking abstinence will be determined
      by carbon monoxide and urine cotinine (a breakdown product of nicotine in cigarette smoke)
      levels. Subjects will be asked to breathe into a breathalyzer to measure carbon monoxide and
      to provide a urine sample to measure cotinine. Smoking abstinence will be confirmed by carbon
      monoxide and cotinine levels that are reduced as compared to actively smoking. We hypothesize
      that smokers at 10-21 days of withdrawal will have amphetamine-induced DA release that is
      blunted compared to healthy nonsmokers.

      Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject to co-register
      PET and MRI for image analysis. Within two weeks of the PET study, an MRI will be acquired at
      the Yale University MRI Center. Subjects will be taken through a ferromagnetic metal detector
      before entering the scan room. The acquisition sequence is a 3D fast spoiled grass (FSPGR) MR
      pulse sequence with an IR prep of 300 ms. (TE= 3.3 ms, flip angle=17 degrees; slice
      thickness= 1.2 mm) optimized for delineating gray matter/white matter/CSF boundaries. The
      small voxel size (0.93 X 1.2 X 0.93 mm) provides high-resolution volumetric images. MR images
      provide a matching anatomical atlas for creating individualized region-of-interest templates
      for each subject.

      Subject preparation consists of two intravenous (IV) catheterizations and immobilization of
      the head. PET scans are acquired as subjects rest using an HRRT PET scanner (207 slices,
      resolution better than 3 mm FWHM). This resolution permits visualization of the PHNO and
      raclopride uptake in the ventral/dorsal striatum, in globus pallidus (GP) and substantia
      nigra (SN). A transmission scan using an orbiting 137Cs point-source is obtained for each
      emission scan. Motion correction will be performed dynamically with measurements from the
      Vicra (NDI Systems, Waterloo, Ontario) used by a dedicated list-mode reconstruction
      algorithm.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.
time frame: first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration
description: PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.
arm group label: amphetamine
arm group type: Experimental
description: There is only one arm to the study. All subjects will receive amphetamine at 0.5mg/kg prior to the second PET scan.
intervention type: Drug
intervention name: Amphetamine
description: All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg
arm group label: amphetamine
other name: dextro-amphetamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly Cosgrove, Ph.D.
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Amphetamine
mesh term: Dextroamphetamine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Preliminary data. Small subject number.
point of contact: 