<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/NCT01699828</url>
  </required_header>
  <id_info>
    <org_study_id>186/2011</org_study_id>
    <nct_id>NCT01699828</nct_id>
  </id_info>
  <brief_title>Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET</brief_title>
  <official_title>Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study is to use positron emission tomography brain imaging to&#xD;
      investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin&#xD;
      partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that&#xD;
      clinically relevant doses of buspirone will occupy the D3 receptor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Buspirone is used for anxiety disorder treatment, a therapeutic effect that has been thought&#xD;
      to be mediated through its partial agonist properties at the serotonin receptor. However,&#xD;
      since one PET study in humans has shown low occupancy of the serotonin by buspirone in&#xD;
      clinical doses and since the DRD3 has been recently implicated in anxiety, some therapeutic&#xD;
      effects of buspirone may be mediated through the DRD3. In human clinical studies, promising&#xD;
      effects of buspirone have been reported for treatment of substance dependence, including&#xD;
      tobacco, marijuana, and opiates, and clinical studies in cocaine dependent subjects are&#xD;
      underway. However, it is unclear if buspirone is producing those effects through the DRD3 and&#xD;
      no human study has incorporated a PET imaging component to investigate this question; it&#xD;
      remains unclear whether buspirone significantly occupies the DRD3 at therapeutic doses in&#xD;
      humans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-response occupancy of buspirone at DRD3</measure>
    <time_frame>few months</time_frame>
    <description>[11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Tobacco Use Cessation</condition>
  <arm_group>
    <arm_group_label>Buspirone 120 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buspirone 120 mg (encapsulated).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buspirone 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buspirone 60 mg (encapsulated)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (encapsulated)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buspirone 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buspirone 30 mg (encapsulated).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buspirone</intervention_name>
    <description>The buspirone will be given once as a tablet and encapsulated for blinding.</description>
    <arm_group_label>Buspirone 120 mg</arm_group_label>
    <arm_group_label>Buspirone 30 mg</arm_group_label>
    <arm_group_label>Buspirone 60 mg</arm_group_label>
    <other_name>Buspar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be lactose and encapsulated for blinding. A single capsule will be given.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>lactose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 19 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical condition including cardiovascular, renal, hepatic or cerebrovascular diseases&#xD;
&#xD;
          -  History of or current neurological illnesses including seizure disorders, migraine,&#xD;
             multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor, - Present or&#xD;
             past psychiatric condition including mood, anxiety, psychotic disorders and substance&#xD;
             abuse and/or dependence.&#xD;
&#xD;
          -  Condition that precludes use of buspirone or that will interfere with participation in&#xD;
             the present study (such as hypersensitive to buspirone hydrochloride).&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Presence of metal objects in the body or implanted electronic devices, that preclude&#xD;
             safe MR scanning.&#xD;
&#xD;
          -  Claustrophobia.&#xD;
&#xD;
          -  Current use or use during the previous month of medication that may affect the CNS,&#xD;
             including monoamine oxidase inhibitor (MAOI) or positive during drug screening for&#xD;
             drugs of abuse or any medication that could increase the risk of buspirone&#xD;
             administration.&#xD;
&#xD;
          -  Exposure to radiation in the last 12 month exceeding permissible limit for subjects&#xD;
             participating in research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle Boileau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Addiction and Mental Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernard Le Foll, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.net/research</url>
    <description>Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching</description>
  </link>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>June 3, 2014</last_update_submitted>
  <last_update_submitted_qc>June 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Bernard Le Foll</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>buspirone</keyword>
  <keyword>smoking cessation</keyword>
  <keyword>dopamine</keyword>
  <keyword>PET imaging</keyword>
  <keyword>[11C]-(+)-PHNO</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buspirone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699828
org study id: 186/2011
nct id: NCT01699828
lead sponsor: 
has dmc: No
The objective of the present study is to use positron emission tomography brain imaging to
      investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin
      partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that
      clinically relevant doses of buspirone will occupy the D3 receptor.
Buspirone is used for anxiety disorder treatment, a therapeutic effect that has been thought
      to be mediated through its partial agonist properties at the serotonin receptor. However,
      since one PET study in humans has shown low occupancy of the serotonin by buspirone in
      clinical doses and since the DRD3 has been recently implicated in anxiety, some therapeutic
      effects of buspirone may be mediated through the DRD3. In human clinical studies, promising
      effects of buspirone have been reported for treatment of substance dependence, including
      tobacco, marijuana, and opiates, and clinical studies in cocaine dependent subjects are
      underway. However, it is unclear if buspirone is producing those effects through the DRD3 and
      no human study has incorporated a PET imaging component to investigate this question; it
      remains unclear whether buspirone significantly occupies the DRD3 at therapeutic doses in
      humans.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Dose-response occupancy of buspirone at DRD3
time frame: few months
description: [11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.
arm group label: Buspirone 120 mg
arm group type: Experimental
description: Buspirone 120 mg (encapsulated).
arm group label: Buspirone 60 mg
arm group type: Experimental
description: Buspirone 60 mg (encapsulated)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (encapsulated)
arm group label: Buspirone 30 mg
arm group type: Experimental
description: Buspirone 30 mg (encapsulated).
intervention type: Drug
intervention name: Buspirone
description: The buspirone will be given once as a tablet and encapsulated for blinding.
arm group label: Buspirone 120 mg
arm group label: Buspirone 30 mg
arm group label: Buspirone 60 mg
other name: Buspar
intervention type: Drug
intervention name: Placebo
description: Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
arm group label: Placebo
other name: lactose
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isabelle Boileau, PhD
role: Principal Investigator
affiliation: Center for Addiction and Mental Health
last name: Bernard Le Foll, MD, PhD
role: Principal Investigator
affiliation: Center for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.net/research
description: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Bernard Le Foll
investigator title: PI
mesh term: Buspirone