<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/NCT02265367</url>
  </required_header>
  <id_info>
    <org_study_id>1409M53561</org_study_id>
    <nct_id>NCT02265367</nct_id>
  </id_info>
  <brief_title>Novel Medication as a Potential Smoking Cessation Aid</brief_title>
  <official_title>Novel Medication as a Potential Smoking Cessation Aid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide preliminary information assessing if levomilnacipran&#xD;
      may be effective at increasing smoking cessation rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Days of Confirmed Abstinence (Out of 5 Maximum)</measure>
    <time_frame>5 days</time_frame>
    <description>Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Levomilnacipran</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levomilnacipran</intervention_name>
    <arm_group_label>Levomilnacipran</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Fetzima</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Levomilnacipran</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 25 years old and 55 years old&#xD;
&#xD;
          -  Smoke a minimum number of cigarettes per day&#xD;
&#xD;
          -  Indicate motivation to quit smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or history of medical or psychiatric conditions that could interfere with&#xD;
             measures being studied or that could be affected by the study medication&#xD;
&#xD;
          -  Use of medication that could interfere with measures to be studied or that could be&#xD;
             expected to interact with levomilnacipran&#xD;
&#xD;
          -  Are pregnant or breast feeding&#xD;
&#xD;
        The investigators will evaluate if there are other reasons why someone may not be eligible&#xD;
        to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Kotlyar, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical and Translational Sciences Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>March 28, 2022</results_first_submitted>
  <results_first_submitted_qc>March 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 22, 2022</results_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Milnacipran</mesh_term>
    <mesh_term>Levomilnacipran</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>February 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02265367/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Levomilnacipran Then Placebo</title>
          <description>In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Then Levomilnacipran</title>
          <description>In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed First 3-week Period</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Levomilnacipran Then Placebo</title>
          <description>In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Then Levomilnacipran</title>
          <description>In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.</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="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" lower_limit="28" upper_limit="55"/>
                    <measurement group_id="B2" value="44" lower_limit="26" upper_limit="55"/>
                    <measurement group_id="B3" value="44" lower_limit="26" upper_limit="55"/>
                  </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="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Days of Confirmed Abstinence (Out of 5 Maximum)</title>
        <description>Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure</description>
        <time_frame>5 days</time_frame>
        <population>Only participants who completed the study were analyzed. Completers were those with data from at least 2 days during the third week of the second three week period</population>
        <group_list>
          <group group_id="O1">
            <title>Levomilnacipran</title>
            <description>In this three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In this three week period, baseline measures are obtained during the first week, placebo during the second week and effects on smoking behavior during the third week</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Days of Confirmed Abstinence (Out of 5 Maximum)</title>
          <description>Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure</description>
          <population>Only participants who completed the study were analyzed. Completers were those with data from at least 2 days during the third week of the second three week period</population>
          <units>percentage of days non-smoking</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9" spread="6.7"/>
                    <measurement group_id="O2" value="42.0" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo</time_frame>
      <desc>Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication</desc>
      <group_list>
        <group group_id="E1">
          <title>Levomilnacipran</title>
          <description>In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week&#xD;
Levomilnacipran</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <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="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="37" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Change in Appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep / Energy Changes</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Excessive Sweating</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Body aches / pains</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Changes in Mood, Anxiety or Irritability Level</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cold / Seasonal Allergy Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Michael Kotlyar</name_or_title>
      <organization>University of Minnesota</organization>
      <phone>612-625-1160</phone>
      <email>kotly001@umn.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/NCT02265367
org study id: 1409M53561
nct id: NCT02265367
lead sponsor: 
has dmc: No
The purpose of this study is to provide preliminary information assessing if levomilnacipran
      may be effective at increasing smoking cessation rates.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
time frame: 5 days
description: Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
arm group label: Levomilnacipran
arm group type: Experimental
description: In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
arm group label: Placebo
arm group type: Experimental
description: In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
intervention type: Drug
intervention name: Levomilnacipran
arm group label: Levomilnacipran
arm group label: Placebo
other name: Fetzima
intervention type: Drug
intervention name: Placebo
arm group label: Levomilnacipran
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Michael Kotlyar, PharmD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Milnacipran
mesh term: Levomilnacipran
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 