<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/NCT03002883</url>
  </required_header>
  <id_info>
    <org_study_id>491744</org_study_id>
    <secondary_id>22BT-0057</secondary_id>
    <nct_id>NCT03002883</nct_id>
  </id_info>
  <brief_title>STAND Community College Tobacco Cessation Trial</brief_title>
  <official_title>Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tobacco Related Disease Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Breathe California of Sacramento-Emigrant Trails</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sacramento City College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Community colleges have 45% of the nation's undergraduates and have a higher smoking&#xD;
      prevalence rate than 4-year colleges. California's community colleges comprise the nation's&#xD;
      largest higher education system, and Sacramento has the second largest community college&#xD;
      district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers&#xD;
      enrolled at community college campuses need greater support. However, community colleges may&#xD;
      lack the student health clinic resources that 4-year colleges have for students who live on&#xD;
      campus. Little evidence to date demonstrates effective interventions for smokers on community&#xD;
      college campuses.&#xD;
&#xD;
      This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation&#xD;
      interventions, compared with usual care on a community college campus. The first intervention&#xD;
      was based on a promising model of brief motivational interviewing delivered by peer&#xD;
      educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails&#xD;
      (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The&#xD;
      second intervention was based on direct enrollment into the California Smokers' Helpline,&#xD;
      which has demonstrated utility for promoting smoking cessation among young adults with low&#xD;
      socioeconomic status. Usual care consisted of students going to the student health center for&#xD;
      smoking cessation assistance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Biochemically validated smoking cessation</measure>
    <time_frame>6 months</time_frame>
    <description>Point prevalence abstinence validated by saliva cotinine level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported smoking cessation</measure>
    <time_frame>6 months</time_frame>
    <description>Point prevalence abstinence by self-report on survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported smoking cessation</measure>
    <time_frame>3 months</time_frame>
    <description>Point prevalence abstinence by self-report on survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported smoking cessation</measure>
    <time_frame>1 month</time_frame>
    <description>Point prevalence abstinence by self-report on survey</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Students referred to student health for tobacco cessation resources including campus &quot;Quit Kits&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief Motivational Interviewing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Students received brief motivational interviewing by a student peer educator about tobacco cessation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct referral to quitline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Students were directly referred to the state quitline for follow-up counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Participant provided &quot;Quit Kit&quot; water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource</description>
    <arm_group_label>Brief Motivational Interviewing</arm_group_label>
    <arm_group_label>Direct referral to quitline</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Motivational Interviewing</intervention_name>
    <description>Peer educator conducts brief motivational interviewing about smoking cessation and participant goals</description>
    <arm_group_label>Brief Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Direct referral to quitline</intervention_name>
    <description>Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan</description>
    <arm_group_label>Direct referral to quitline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult 18 years or older&#xD;
&#xD;
          -  current smoker in the past 30 days&#xD;
&#xD;
          -  smoker wants to quit&#xD;
&#xD;
          -  smoker not currently participating in other smoking cessation activities, and&#xD;
&#xD;
          -  smoker must be willing to accept randomization into any of the 3 study arms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  students not proficient in communicating in English&#xD;
&#xD;
          -  adults unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa Tong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03002883
org study id: 491744
secondary id: 22BT-0057
nct id: NCT03002883
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Community colleges have 45% of the nation's undergraduates and have a higher smoking
      prevalence rate than 4-year colleges. California's community colleges comprise the nation's
      largest higher education system, and Sacramento has the second largest community college
      district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers
      enrolled at community college campuses need greater support. However, community colleges may
      lack the student health clinic resources that 4-year colleges have for students who live on
      campus. Little evidence to date demonstrates effective interventions for smokers on community
      college campuses.

      This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation
      interventions, compared with usual care on a community college campus. The first intervention
      was based on a promising model of brief motivational interviewing delivered by peer
      educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails
      (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The
      second intervention was based on direct enrollment into the California Smokers' Helpline,
      which has demonstrated utility for promoting smoking cessation among young adults with low
      socioeconomic status. Usual care consisted of students going to the student health center for
      smoking cessation assistance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biochemically validated smoking cessation
time frame: 6 months
description: Point prevalence abstinence validated by saliva cotinine level
measure: Self-reported smoking cessation
time frame: 6 months
description: Point prevalence abstinence by self-report on survey
measure: Self-reported smoking cessation
time frame: 3 months
description: Point prevalence abstinence by self-report on survey
measure: Self-reported smoking cessation
time frame: 1 month
description: Point prevalence abstinence by self-report on survey
arm group label: Usual Care
arm group type: Placebo Comparator
description: Students referred to student health for tobacco cessation resources including campus "Quit Kits"
arm group label: Brief Motivational Interviewing
arm group type: Active Comparator
description: Students received brief motivational interviewing by a student peer educator about tobacco cessation
arm group label: Direct referral to quitline
arm group type: Active Comparator
description: Students were directly referred to the state quitline for follow-up counseling
intervention type: Behavioral
intervention name: Usual Care
description: Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource
arm group label: Brief Motivational Interviewing
arm group label: Direct referral to quitline
arm group label: Usual Care
intervention type: Behavioral
intervention name: Brief Motivational Interviewing
description: Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
arm group label: Brief Motivational Interviewing
intervention type: Behavioral
intervention name: Direct referral to quitline
description: Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan
arm group label: Direct referral to quitline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elisa Tong, MD
role: Principal Investigator
affiliation: University of California, Davis
responsible party type: Sponsor
sharing ipd: No