<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/NCT03266939</url>
  </required_header>
  <id_info>
    <org_study_id>cocaine and serotonin</org_study_id>
    <nct_id>NCT03266939</nct_id>
  </id_info>
  <brief_title>Rebalancing the Serotonergic System in Cocaine Dependence</brief_title>
  <official_title>Rebalancing the Serotonergic System in Cocaine Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the United States, 1.5 million people abuse cocaine leading to a host of negative health&#xD;
      and economic consequences, yet no FDA approved treatment exists. To develop effective&#xD;
      treatments, the following must be considered: 1) do potential medications ameliorate brain&#xD;
      disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To&#xD;
      meet these goals, innovative multi-modal neuroimaging will be used to determine whether&#xD;
      rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and&#xD;
      normalizes related neurochemistry and brain connectivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 4, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.</measure>
    <time_frame>fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cocaine Dependence</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Medication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorcaserin</intervention_name>
    <description>10 mg acute administration of lorcasein</description>
    <arm_group_label>Active Medication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Participants will be male and female volunteers between the ages of 18-55&#xD;
&#xD;
          -  Participants will report having used cocaine on at least four occasions within the&#xD;
             month prior to screening; the urine sample obtained during the screening visit must be&#xD;
             positive for the cocaine metabolite benzoylecgonine (&gt;300 ng/ml). They can meet DSM-IV&#xD;
             criteria for cocaine abuse and dependence.&#xD;
&#xD;
          -  Participants cannot meet DSM-IV criteria for current psychotic disorders (e.g.,&#xD;
             bipolar disorder, schizophrenia, schizoaffective disorder)&#xD;
&#xD;
          -  Participants cannot meet DSM-IV criteria for a current major depressive episode&#xD;
&#xD;
          -  Participants cannot meet DSM-IV criteria for current drug dependence (except nicotine,&#xD;
             cocaine, and marihuana)&#xD;
&#xD;
          -  Participants must test negative for alcohol use on the day of the scan.&#xD;
&#xD;
          -  Participants can report current abuse of marihuana and tobacco. Participants cannot&#xD;
             have used marihuana within twelve hours of their study visits.&#xD;
&#xD;
          -  Participants cannot be regular opiate users including prescription opiate analgesics&#xD;
&#xD;
          -  Participants cannot have a history of major head trauma resulting in cognitive&#xD;
             impairment, seizure, or other neurological disorders.&#xD;
&#xD;
          -  Participants cannot have any conditions that are contraindicated for MRI (see next&#xD;
             section)&#xD;
&#xD;
          -  Participants cannot be pregnant (pregnancy test will be performed before each scanning&#xD;
             session)&#xD;
&#xD;
          -  Participants must be able to read screening materials including consent form and give&#xD;
             informed consent&#xD;
&#xD;
          -  Participants cannot be taking any medications with a 5-HT mechanism including&#xD;
             serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake&#xD;
             inhibitors (SSRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors&#xD;
             (MAOIs) and St. John's Wort and tryptophan.&#xD;
&#xD;
          -  Participants cannot be currently taking any medications that might affect the central&#xD;
             nervous system including prescription analgesics, anxiolytics, antipsychotics, and&#xD;
             antidepressants. A complete review of medications will be evaluated by study staff.&#xD;
&#xD;
          -  Cannot have any history of a medical condition that might affect the central nervous&#xD;
             system at the time of scanning including: Abnormal structural MRI, or a history of&#xD;
             head trauma or injury causing loss of consciousness lasting longer than 3 minutes or&#xD;
             associated with skull fracture or intracranial bleeding or who had irremovable&#xD;
             magnetically active objects on or within their body, or history of epilepsy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Weight greater than 350 pounds (cannot easily fit inside the magnet bore)&#xD;
&#xD;
          -  Cardiac pacemakers&#xD;
&#xD;
          -  Aneurysm clips and other vascular stents, filters, clips or other devices&#xD;
&#xD;
          -  Prosthetic heart valves&#xD;
&#xD;
          -  Other prostheses&#xD;
&#xD;
          -  Neuro-stimulator devices&#xD;
&#xD;
          -  Implanted infusion pumps&#xD;
&#xD;
          -  Cochlear implants&#xD;
&#xD;
          -  Ocular implants or known metal fragments in eyes&#xD;
&#xD;
          -  Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)&#xD;
&#xD;
          -  Other metallic surgical hardware in vital areas&#xD;
&#xD;
          -  History of major head trauma resulting in cognitive impairment&#xD;
&#xD;
          -  Certain tattoos (e.g. older dye with metallic pigment)&#xD;
&#xD;
          -  Certain medication patches (if they cannot be removed)&#xD;
&#xD;
          -  Metal containing IUDs&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metallic implants except fillings and crowns&#xD;
&#xD;
          -  Tattoos containing metallic ink on the neck, shoulders, upper arm, and head (these&#xD;
             could become heated during scanning, potentially causing burns&#xD;
&#xD;
          -  Medication patches that cannot be removed during scanning&#xD;
&#xD;
          -  Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Janes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Amy C. Janes</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
  </condition_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/NCT03266939
org study id: cocaine and serotonin
nct id: NCT03266939
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
In the United States, 1.5 million people abuse cocaine leading to a host of negative health
      and economic consequences, yet no FDA approved treatment exists. To develop effective
      treatments, the following must be considered: 1) do potential medications ameliorate brain
      disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To
      meet these goals, innovative multi-modal neuroimaging will be used to determine whether
      rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and
      normalizes related neurochemistry and brain connectivity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.
time frame: fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart)
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Active Medication
arm group type: Active Comparator
intervention type: Drug
intervention name: Lorcaserin
description: 10 mg acute administration of lorcasein
arm group label: Active Medication
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Amy Janes, PhD
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Amy C. Janes
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
sharing ipd: No