<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/NCT03007394</url>
  </required_header>
  <id_info>
    <org_study_id>NIDA/VACSP #1033</org_study_id>
    <nct_id>NCT03007394</nct_id>
  </id_info>
  <brief_title>Lorcaserin in the Treatment of Cocaine Use Disorder</brief_title>
  <official_title>Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute on Drug Abuse (NIDA)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The objective of this study is to evaluate the efficacy and safety of lorcaserin in the&#xD;
      treatment of cocaine use disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of&#xD;
      lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3&#xD;
      weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week&#xD;
      follow-up period, with scheduled visits during Study weeks 14 and 16.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the &quot;Pre-qualified for Primary Efficacy Endpoint&quot; (PPEE) Population</measure>
    <time_frame>Treatment weeks 11 - 13</time_frame>
    <description>Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence</measure>
    <time_frame>Treatment weeks 11-13</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Cocaine-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Lorcaserin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg capsule by mouth, twice a day, for 13 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10 mg placebo capsule, twice a day, for 13 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorcaserin</intervention_name>
    <description>Lorcaserin Capsule</description>
    <arm_group_label>Lorcaserin</arm_group_label>
    <other_name>Belviq</other_name>
    <other_name>lorcaserin hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>sugar pill to mimic lorcaserin 10mg capsule</description>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured&#xD;
             Clinical Interview for DSM-5&#xD;
&#xD;
          -  Is seeking treatment for cocaine use disorder&#xD;
&#xD;
          -  Is able to understand and provide written informed consent&#xD;
&#xD;
          -  Has used cocaine on at least 1 day in the last 30 days prior to screening&#xD;
&#xD;
          -  Has completed all psychological assessments and procedures during the screening period&#xD;
&#xD;
          -  If female, not pregnant, lactating, unable to conceive OR must agree to use an&#xD;
             acceptable method of birth control&#xD;
&#xD;
          -  Has a total body weight greater than 110 pounds and body mass index greater than 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contact site for more information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shwe Gyaw, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Institute on Drug Abuse (NIDA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pacific Treatment and Research Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matrix Institute on Addictions</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660-2452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Clinical Research, Inc.</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118-2391</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altea Research Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Behavioral Clinical Research Inc.</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CODA, Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>June 2, 2020</results_first_submitted>
  <results_first_submitted_qc>June 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2020</results_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cocaine Use Disorder</keyword>
  <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>
  <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>April 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03007394/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lorcaserin</title>
          <description>10 mg capsule by mouth, twice a day, for 13 weeks&#xD;
Lorcaserin: Lorcaserin Capsule</description>
        </group>
        <group group_id="P2">
          <title>Placebo Oral Capsule</title>
          <description>10 mg placebo capsule, twice a day, for 13 weeks&#xD;
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg 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="118"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The &quot;Intent-to-Treat (ITT) Population&quot; of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization.&#xD;
2) The &quot;PPEE Population&quot; of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization</population>
      <group_list>
        <group group_id="B1">
          <title>Lorcaserin</title>
          <description>10 mg capsule by mouth, twice a day, for 13 weeks&#xD;
Lorcaserin: Lorcaserin Capsule</description>
        </group>
        <group group_id="B2">
          <title>Placebo Oral Capsule</title>
          <description>10 mg placebo capsule, twice a day, for 13 weeks&#xD;
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule</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="118"/>
            <count group_id="B2" value="124"/>
            <count group_id="B3" value="242"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.0" spread="9.88"/>
                    <measurement group_id="B2" value="50.3" spread="9.99"/>
                    <measurement group_id="B3" value="50.2" spread="9.92"/>
                  </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="28"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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>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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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="118"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the &quot;Pre-qualified for Primary Efficacy Endpoint&quot; (PPEE) Population</title>
        <description>Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.</description>
        <time_frame>Treatment weeks 11 - 13</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lorcaserin</title>
            <description>10 mg capsule by mouth, twice a day, for 13 weeks&#xD;
Lorcaserin: Lorcaserin Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>10 mg placebo capsule, twice a day, for 13 weeks&#xD;
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule</description>
          </group>
        </group_list>
        <measure>
          <title>The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the &quot;Pre-qualified for Primary Efficacy Endpoint&quot; (PPEE) Population</title>
          <description>Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence</title>
        <time_frame>Treatment weeks 11-13</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lorcaserin</title>
            <description>10 mg capsule by mouth, twice a day, for 13 weeks&#xD;
Lorcaserin: Lorcaserin Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>10 mg placebo capsule, twice a day, for 13 weeks&#xD;
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule</description>
          </group>
        </group_list>
        <measure>
          <title>The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected every week during treatment and through study follow-up, a 13-week treatment phase with a 4-week follow-up period.</time_frame>
      <desc>The &quot;Intent-to-Treat (ITT) Population&quot; of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization as noted in the total for the participant flow.&#xD;
The &quot;PPEE Population&quot; of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization, which is the subset population used here</desc>
      <group_list>
        <group group_id="E1">
          <title>Lorcaserin</title>
          <description>10 mg capsule by mouth, twice a day, for 13 weeks&#xD;
Lorcaserin: Lorcaserin Capsule</description>
        </group>
        <group group_id="E2">
          <title>Placebo Oral Capsule</title>
          <description>10 mg placebo capsule, twice a day, for 13 weeks&#xD;
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Life threatening and hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Life threatening and hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distress</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bodily injury</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increase/decrease</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Body pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression/Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="124"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David McCann, Ph.D.</name_or_title>
      <organization>National Institute on Drug Abuse</organization>
      <phone>301-827-5934</phone>
      <email>dmccann@nida.nih.gov</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/NCT03007394
org study id: NIDA/VACSP #1033
nct id: NCT03007394
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the
      treatment of cocaine use disorder.
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of
      lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3
      weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week
      follow-up period, with scheduled visits during Study weeks 14 and 16.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population
time frame: Treatment weeks 11 - 13
description: Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.
measure: The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence
time frame: Treatment weeks 11-13
arm group label: Lorcaserin
arm group type: Active Comparator
description: 10 mg capsule by mouth, twice a day, for 13 weeks
arm group label: Placebo Oral Capsule
arm group type: Placebo Comparator
description: 10 mg placebo capsule, twice a day, for 13 weeks
intervention type: Drug
intervention name: Lorcaserin
description: Lorcaserin Capsule
arm group label: Lorcaserin
other name: Belviq
other name: lorcaserin hydrochloride
intervention type: Drug
intervention name: Placebo Oral Capsule
description: sugar pill to mimic lorcaserin 10mg capsule
arm group label: Placebo Oral Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shwe Gyaw, MD
role: Study Chair
affiliation: National Institute on Drug Abuse (NIDA)
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 