<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/NCT03822416</url>
  </required_header>
  <id_info>
    <org_study_id>SPH-2018-26854</org_study_id>
    <nct_id>NCT03822416</nct_id>
  </id_info>
  <brief_title>Treating Smokers With Mental Illness</brief_title>
  <official_title>Treating Tobacco Dependence in Smokers With Severe Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hennepin County Medical Center, Minneapolis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a smoking cessation study that will enroll smokers who have been diagnosed with a&#xD;
      severe mental illness. The study will use a combination of intensive tobacco treatment&#xD;
      counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting&#xD;
      smoking over the course of six months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the baseline measurement visit, participants will be asked to complete a survey and an&#xD;
      interview. They will be randomly assigned to either the intervention or control group. Both&#xD;
      groups will receive a smoking cessation manual and list of resources. The intervention group&#xD;
      will also receive smoking cessation counseling and nicotine replacement therapy. Both groups&#xD;
      will be seen for in-person assessments again at 8 weeks and 6 months post baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">May 4, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</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>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>7-Day Point Prevalence Abstinence</measure>
    <time_frame>8 weeks and 6 months post baseline</time_frame>
    <description>To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quit Attempts</measure>
    <time_frame>8 weeks and 6 months post baseline</time_frame>
    <description>To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking Reduction</measure>
    <time_frame>8 weeks and 6 months post baseline</time_frame>
    <description>To determine the mean reduction in cigarettes per day in the intervention and control conditions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Cigarette Smoking</condition>
  <condition>Schizophrenia</condition>
  <condition>Psychotic Disorders</condition>
  <condition>Major Depressive Disorder</condition>
  <condition>Bipolar Disorder I</condition>
  <condition>Bipolar II Disorder</condition>
  <condition>Mental Illness</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine patch</intervention_name>
    <description>Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine lozenge</intervention_name>
    <description>Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapy</intervention_name>
    <description>In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a severe mental illness diagnosis&#xD;
&#xD;
          -  be a daily smoker&#xD;
&#xD;
          -  be willing to reduce the number of cigarettes smoked per day leading to a quit attempt&#xD;
&#xD;
          -  want to try to quit smoking&#xD;
&#xD;
          -  be willing to use nicotine replacement therapy&#xD;
&#xD;
          -  be able to communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anyone who has had an active psychotic episode or been hospitalized due to suicidal&#xD;
             ideation in the last six months&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  taking Chantix or Clozapine&#xD;
&#xD;
          -  having a terminal illness&#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>Harry Lando, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</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>May 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>May 3, 2021</results_first_submitted>
  <results_first_submitted_qc>May 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2021</results_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mental illness</keyword>
  <keyword>tobacco treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_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>July 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03822416/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03822416/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</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="19"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="38"/>
          </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="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <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="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="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>7-Day Point Prevalence Abstinence</title>
        <description>To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.</description>
        <time_frame>8 weeks and 6 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
        </group_list>
        <measure>
          <title>7-Day Point Prevalence Abstinence</title>
          <description>To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quit Attempts</title>
        <description>To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.</description>
        <time_frame>8 weeks and 6 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
        </group_list>
        <measure>
          <title>Quit Attempts</title>
          <description>To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Smoking Reduction</title>
        <description>To determine the mean reduction in cigarettes per day in the intervention and control conditions.</description>
        <time_frame>8 weeks and 6 months post baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Reduction</title>
          <description>To determine the mean reduction in cigarettes per day in the intervention and control conditions.</description>
          <units>cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>8 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="7.04"/>
                    <measurement group_id="O2" value="11.59" spread="4.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="4.56"/>
                    <measurement group_id="O2" value="8.03" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.&#xD;
Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use&#xD;
Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.&#xD;
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>increased coughing following smoking cessation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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>Harry Lando, PhD</name_or_title>
      <organization>University of Minnesota</organization>
      <phone>612-624-1877</phone>
      <email>lando001@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/NCT03822416
org study id: SPH-2018-26854
nct id: NCT03822416
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a smoking cessation study that will enroll smokers who have been diagnosed with a
      severe mental illness. The study will use a combination of intensive tobacco treatment
      counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting
      smoking over the course of six months.
At the baseline measurement visit, participants will be asked to complete a survey and an
      interview. They will be randomly assigned to either the intervention or control group. Both
      groups will receive a smoking cessation manual and list of resources. The intervention group
      will also receive smoking cessation counseling and nicotine replacement therapy. Both groups
      will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
measure: 7-Day Point Prevalence Abstinence
time frame: 8 weeks and 6 months post baseline
description: To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.
measure: Quit Attempts
time frame: 8 weeks and 6 months post baseline
description: To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
measure: Smoking Reduction
time frame: 8 weeks and 6 months post baseline
description: To determine the mean reduction in cigarettes per day in the intervention and control conditions.
arm group label: Intervention
arm group type: Experimental
description: Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
arm group label: Control
arm group type: Other
description: Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
intervention type: Drug
intervention name: Nicotine patch
description: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
arm group label: Intervention
intervention type: Drug
intervention name: Nicotine lozenge
description: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
arm group label: Intervention
intervention type: Behavioral
intervention name: Therapy
description: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase
arm group label: Intervention
intervention type: Other
intervention name: Information
description: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harry Lando, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Bipolar Disorder
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Nicotine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 