<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/NCT02206971</url>
  </required_header>
  <id_info>
    <org_study_id>2008NT001 (1203M11223)</org_study_id>
    <nct_id>NCT02206971</nct_id>
  </id_info>
  <brief_title>Biomarker Feedback for Smoking Cessation</brief_title>
  <official_title>Biomarker Feedback for Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the impact of providing light smokers with feedback&#xD;
      about their health, including exposure to tobacco-related chemicals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The smoking pattern among adults in the US is undergoing a remarkable change. A substantial&#xD;
      proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is&#xD;
      known about how to help light smokers quit. The prevalence of light smoking is high (~50%)&#xD;
      among African Americans (AAs) who compared to other groups have high cotinine levels, are&#xD;
      less successful quitting smoking, and experience disproportionately higher smoking-related&#xD;
      cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a&#xD;
      potential smoking cessation strategy is therefore to provide light smokers with feedback on&#xD;
      biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is&#xD;
      to develop and pilot test a biomarker risk assessment intervention to enhance smoking&#xD;
      cessation for AA light smokers. The proposal builds on our previous work that shows that&#xD;
      light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high&#xD;
      levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize&#xD;
      focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well&#xD;
      as preferences about how participants would like to receive biomarker feedback (BF; e.g. by&#xD;
      mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a&#xD;
      (BF) intervention for light smokers. The new intervention will undergo further feasibility&#xD;
      evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures,&#xD;
      (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with&#xD;
      smoking reduction or cessation. By the end of the proposed pilot study, we expect to have&#xD;
      developed a replicable, feasible, and acceptable BF intervention that will be ready for&#xD;
      efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The&#xD;
      aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and&#xD;
      preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF&#xD;
      intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a&#xD;
      BF intervention for smoking cessation in AA light smokers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>urinary cotinine level</measure>
    <time_frame>week 0, week 8, week 26</time_frame>
    <description>changes to biomarker levels with smoking reduction or cessation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Feedback Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive a Smoking Cessation Manual, the opportunity for smoking cessation counseling on the phone, and urine analyses feedback via the mail plus a phone call to discuss the information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>receive a Smoking Cessation Manual and the opportunity for smoking cessation counseling on the phone</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>urine analyses feedback</intervention_name>
    <description>biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL</description>
    <arm_group_label>Feedback Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female cigarette smokers, 18-75 years&#xD;
&#xD;
          -  Smoked an average of less than 10 cigarettes per day during past month&#xD;
&#xD;
          -  A personally signed and dated informed consent document indicating that the subject&#xD;
             has been informed of all pertinent aspects of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Only one subject per household may participate&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02206971
org study id: 2008NT001 (1203M11223)
nct id: NCT02206971
lead sponsor: 
has dmc: No
The purpose of this study is to examine the impact of providing light smokers with feedback
      about their health, including exposure to tobacco-related chemicals.
The smoking pattern among adults in the US is undergoing a remarkable change. A substantial
      proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is
      known about how to help light smokers quit. The prevalence of light smoking is high (~50%)
      among African Americans (AAs) who compared to other groups have high cotinine levels, are
      less successful quitting smoking, and experience disproportionately higher smoking-related
      cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a
      potential smoking cessation strategy is therefore to provide light smokers with feedback on
      biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is
      to develop and pilot test a biomarker risk assessment intervention to enhance smoking
      cessation for AA light smokers. The proposal builds on our previous work that shows that
      light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high
      levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize
      focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well
      as preferences about how participants would like to receive biomarker feedback (BF; e.g. by
      mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a
      (BF) intervention for light smokers. The new intervention will undergo further feasibility
      evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures,
      (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with
      smoking reduction or cessation. By the end of the proposed pilot study, we expect to have
      developed a replicable, feasible, and acceptable BF intervention that will be ready for
      efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The
      aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and
      preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF
      intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a
      BF intervention for smoking cessation in AA light smokers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: urinary cotinine level
time frame: week 0, week 8, week 26
description: changes to biomarker levels with smoking reduction or cessation
arm group label: Feedback Group
arm group type: Active Comparator
description: receive a Smoking Cessation Manual, the opportunity for smoking cessation counseling on the phone, and urine analyses feedback via the mail plus a phone call to discuss the information
arm group label: Standard Care
arm group type: No Intervention
description: receive a Smoking Cessation Manual and the opportunity for smoking cessation counseling on the phone
intervention type: Other
intervention name: urine analyses feedback
description: biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL
arm group label: Feedback Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor