<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/NCT02191033</url>
  </required_header>
  <id_info>
    <org_study_id>1404013813</org_study_id>
    <nct_id>NCT02191033</nct_id>
  </id_info>
  <brief_title>Text Messaging for Smoking Cessation in College Health Clinics</brief_title>
  <official_title>Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Connecticut State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Haven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized-controlled clinical trial which evaluates the efficacy of&#xD;
      physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in&#xD;
      promoting cigarette smoking in smokers enrolled in college.&#xD;
&#xD;
      The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement&#xD;
      therapy, and text messaging will have higher quit rates that smokers receiving physician&#xD;
      brief advice and nicotine replacement therapy alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study Enrollment- Number of Participants Who Join the Study</measure>
    <time_frame>baseline</time_frame>
    <description>We will report the number of persons who join the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.</measure>
    <time_frame>6- and 12- weeks</time_frame>
    <description>We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking Abstinence</measure>
    <time_frame>6- and 12- weeks</time_frame>
    <description>biochemically confirmed point prevalence of self reported past 7-day abstinence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Text messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoking counseling, nicotine patch, text messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoking counseling, nicotine patch</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking counseling</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_label>Text messaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text messaging</intervention_name>
    <arm_group_label>Text messaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine patch</intervention_name>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_label>Text messaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 through 24 years&#xD;
&#xD;
          -  Enrolled as a full/part time college student&#xD;
&#xD;
          -  A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke&#xD;
             every day or some days)&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Interested in quitting&#xD;
&#xD;
          -  Have a cell phone for personal use with an unlimited text messaging plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity/allergy to nicotine patch;&#xD;
&#xD;
          -  Serious arrhythmias - History of heart disease (myocardial infarction, severe chest&#xD;
             pain, or coronary artery disease)&#xD;
&#xD;
          -  Current pregnancy/breastfeeding/plan for pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deepa R Camenga, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Connecticut State University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>April 27, 2017</results_first_submitted>
  <results_first_submitted_qc>April 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2017</results_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cigarette smoking</keyword>
  <keyword>tobacco use cessation products</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment open from January 2015 to May 2016. Recruited from local college campuses.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Text Messaging</title>
          <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Nicotine patch&#xD;
Text messaging</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Text Messaging</title>
          <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Text messaging&#xD;
Nicotine patch</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </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="19.9" spread="1.7"/>
                    <measurement group_id="B2" value="20.5" spread="1.5"/>
                    <measurement group_id="B3" value="20.2" spread="1.6"/>
                  </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="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>American Indian/Alaskan Native</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_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="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Study Enrollment- Number of Participants Who Join the Study</title>
        <description>We will report the number of persons who join the study.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Nicotine patch&#xD;
Text messaging</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</description>
          </group>
        </group_list>
        <measure>
          <title>Study Enrollment- Number of Participants Who Join the Study</title>
          <description>We will report the number of persons who join the study.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.</title>
        <description>We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.</description>
        <time_frame>6- and 12- weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Nicotine patch&#xD;
Text messaging</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</description>
          </group>
        </group_list>
        <measure>
          <title>Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.</title>
          <description>We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-week retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-week retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Smoking Abstinence</title>
        <description>biochemically confirmed point prevalence of self reported past 7-day abstinence</description>
        <time_frame>6- and 12- weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Text Messaging</title>
            <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Nicotine patch&#xD;
Text messaging</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Abstinence</title>
          <description>biochemically confirmed point prevalence of self reported past 7-day abstinence</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From January 2015 through August 2016</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Text Messaging</title>
          <description>Smoking counseling, nicotine patch, text messaging&#xD;
Smoking counseling&#xD;
Nicotine patch&#xD;
Text messaging</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Smoking counseling, nicotine patch&#xD;
Smoking counseling&#xD;
Nicotine patch</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <limitations_and_caveats>This is a pilot and feasibility study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Deepa Camenga, MD</name_or_title>
      <organization>Yale University</organization>
      <phone>203-737-8310</phone>
      <email>deepa.camenga@yale.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/NCT02191033
org study id: 1404013813
nct id: NCT02191033
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is a randomized-controlled clinical trial which evaluates the efficacy of
      physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in
      promoting cigarette smoking in smokers enrolled in college.

      The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement
      therapy, and text messaging will have higher quit rates that smokers receiving physician
      brief advice and nicotine replacement therapy alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Study Enrollment- Number of Participants Who Join the Study
time frame: baseline
description: We will report the number of persons who join the study.
measure: Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.
time frame: 6- and 12- weeks
description: We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.
measure: Smoking Abstinence
time frame: 6- and 12- weeks
description: biochemically confirmed point prevalence of self reported past 7-day abstinence
arm group label: Text messaging
arm group type: Experimental
description: Smoking counseling, nicotine patch, text messaging
arm group label: Standard of care
arm group type: Active Comparator
description: Smoking counseling, nicotine patch
intervention type: Behavioral
intervention name: Smoking counseling
arm group label: Standard of care
arm group label: Text messaging
intervention type: Behavioral
intervention name: Text messaging
arm group label: Text messaging
intervention type: Drug
intervention name: Nicotine patch
arm group label: Standard of care
arm group label: Text messaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deepa R Camenga, MD
role: Principal Investigator
affiliation: Yale School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is a pilot and feasibility study.
point of contact: 