<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/NCT02974582</url>
  </required_header>
  <id_info>
    <org_study_id>170015</org_study_id>
    <secondary_id>17-MD-0015</secondary_id>
    <nct_id>NCT02974582</nct_id>
  </id_info>
  <brief_title>Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers</brief_title>
  <official_title>Understanding How Cigarette Direct Mail Marketing Influence Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Smoking is a major public health problem in the U.S. Almost a half a million Americans die&#xD;
      from it in a year. One thing that contributes to why people smoke is the marketing of&#xD;
      cigarettes. Cigarette direct mail marketing usually targets young smokers of lower&#xD;
      socioeconomic status. Researchers want to find out more about how this kind of marketing&#xD;
      influences smoking behavior in young people from different socioeconomic levels.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal.&#xD;
      To study how these things may differ among young adult smokers of high and low socioeconomic&#xD;
      status.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy adults ages 18 to 29 who smoke.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will have 1 visit.&#xD;
&#xD;
      Participants will be asked questions about their health and recent smoking.&#xD;
&#xD;
      A nurse will check their vital signs.&#xD;
&#xD;
      Participants will have a simple eye exam.&#xD;
&#xD;
      They will give blood and urine samples.&#xD;
&#xD;
      Participants will be connected to equipment. This will collect data while they look at&#xD;
      pictures.&#xD;
&#xD;
      Then they will have a 10-minute break. A nurse will observe them during the break.&#xD;
&#xD;
      Participants will have their breath analyzed.&#xD;
&#xD;
      Participants will answer questions. The topics will include:&#xD;
&#xD;
      Education&#xD;
&#xD;
      Job&#xD;
&#xD;
      Income&#xD;
&#xD;
      Family history&#xD;
&#xD;
      Tobacco use&#xD;
&#xD;
      Exposure to pro-smoking and anti-smoking messages&#xD;
&#xD;
      History of drug and alcohol use&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking remains a public health problem in the US, and cigarette marketing has been concluded&#xD;
      as one of the causal factors for the epidemic. Previous studies on cigarette direct mail&#xD;
      marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there&#xD;
      is a need for a study that would provide a stronger evidence on how direct mail marketing&#xD;
      influences smoking behavior. The proposed study will consist of two parts where pilot data&#xD;
      are to be collected in Part 1, and further data are to be collected in Part 2 conducted as a&#xD;
      randomized comparative trial. Up to a total of 530 healthy volunteers ages 18-29 are to be&#xD;
      recruited for the study. After meeting the eligibility and enrolling onto the study,&#xD;
      participants will have their biospecimens collected followed by an experiment in which they&#xD;
      are to be shown images on the computer. Study participants will then take a break and&#xD;
      afterwards will provide additional sociodemographic and psychosocial information through an&#xD;
      audio computer assisted self-administered interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 5, 2023</start_date>
  <completion_date type="Anticipated">October 6, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 6, 2025</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.</measure>
    <time_frame>1 Day</time_frame>
    <description>Measure of physiological responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To conduct a randomized comparative trial to examine the effect of cigarette direct mail materials on beliefs, affective responses, arousal, and smoking behavior, and their variation by SES among young adult smokers.</measure>
    <time_frame>1 Day</time_frame>
    <description>Measure of physiological responses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.</measure>
    <time_frame>1 Day</time_frame>
    <description>Measure of physiological responses.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">530</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>1/Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 Participants of high and low SES</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2/Part 2 - Discount Coupons</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized to view direct mail marketing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3/Part 2 - No Discount Coupons</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized to view direct mail marketing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4/Part 2 - Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized to view direct mail marketing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure to smoking advertising with coupon</intervention_name>
    <description>Direct mail marketing of smoking advertising with discount coupon</description>
    <arm_group_label>2/Part 2 - Discount Coupons</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure to smoking advertising without coupons</intervention_name>
    <description>Direct mail marketing of smoking advertising without discount coupon</description>
    <arm_group_label>3/Part 2 - No Discount Coupons</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure to non health related images</intervention_name>
    <description>Control group</description>
    <arm_group_label>1/Part 1</arm_group_label>
    <arm_group_label>4/Part 2 - Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Age: 18 to 29 years, given our focus on young adults.&#xD;
&#xD;
          -  Smoking status: Current smokers who report smoking every day and who have smoked at&#xD;
             least 100 cigarettes in their lifetime with a breath carbon monoxide level greater&#xD;
             than 6ppm per device guidelines&#xD;
&#xD;
          -  SES: For the purpose of the study, we will use the empirical groups from our analysis&#xD;
             of the Current Population Survey -Tobacco Use Supplement data. Two groups are chosen&#xD;
             based on their social determinants and prevalence of smoking.&#xD;
&#xD;
               1. Low SES: Young adults who do not have a four-year college degree, are not&#xD;
                  currently enrolled in a four-year college, were born in the US, and have an&#xD;
                  annual income less than $50,000. This is the group that has been shown to have&#xD;
                  the highest prevalence of smoking.&#xD;
&#xD;
               2. High SES: Young adults who are currently enrolled in or graduated from a four&#xD;
                  year college. This is the group that has been shown to have the lowest prevalence&#xD;
                  of smoking.&#xD;
&#xD;
          -  English proficiency: since study materials are available only in English, only&#xD;
             participants who are able to understand English and follow instructions in English are&#xD;
             to be enrolled.&#xD;
&#xD;
          -  Cognitive ability: Able to understand and willing to sign a written informed consent&#xD;
             document.&#xD;
&#xD;
          -  General health: Participants need to be generally healthy, as defined as someone with&#xD;
             no known significant health problems. Participants can have chronic health conditions&#xD;
             if the condition is well managed.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Inability, in the judgment of the investigator, to understand and follow the&#xD;
             requirements of the protocol.&#xD;
&#xD;
          -  Currently enrolled in high school.&#xD;
&#xD;
          -  Participants with eye conditions that restrict their ability to track an object with&#xD;
             their eyes.&#xD;
&#xD;
          -  Participants with myopia, hyperopia, and/or astigmatism who cannot pass a simple&#xD;
             vision test even with corrective lenses.&#xD;
&#xD;
          -  Participants with medical condition(s) that may be triggered by infrared radiation&#xD;
             (e.g., epilepsy).&#xD;
&#xD;
          -  Self-reported use of alcohol, recreational drugs or prescription medications used for&#xD;
             recreational purposes (e. g. amphetamines, cannabis, cocaine, MDMA, ketamines, LSD,&#xD;
             opiates and opioids, tranquilizers or opioid analgesics) that may influence their&#xD;
             judgement at the time of study in the past 12 hours before the study visit.&#xD;
&#xD;
          -  Participants who cannot see an object located between 15 to 27 inches away from them&#xD;
             (the required distance between the computer screen and the participants for accurate&#xD;
             eye-tracking), even with corrective contact lenses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsz (Kelvin) C Choi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute on Minority Health and Health Disparities (NIMHD)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bambi JE Jewett</last_name>
    <phone>(301) 827-0493</phone>
    <email>bambi.jewett@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tsz (Kelvin) C Choi, Ph.D.</last_name>
    <phone>(301) 496-3400</phone>
    <email>tsz.choi@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-MD-0015.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 9, 2023</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cigarettes</keyword>
  <keyword>Behaviors</keyword>
  <keyword>Attitudes</keyword>
  <keyword>Beliefs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02974582
org study id: 170015
secondary id: 17-MD-0015
nct id: NCT02974582
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Smoking is a major public health problem in the U.S. Almost a half a million Americans die
      from it in a year. One thing that contributes to why people smoke is the marketing of
      cigarettes. Cigarette direct mail marketing usually targets young smokers of lower
      socioeconomic status. Researchers want to find out more about how this kind of marketing
      influences smoking behavior in young people from different socioeconomic levels.

      Objectives:

      To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal.
      To study how these things may differ among young adult smokers of high and low socioeconomic
      status.

      Eligibility:

      Healthy adults ages 18 to 29 who smoke.

      Design:

      Participants will have 1 visit.

      Participants will be asked questions about their health and recent smoking.

      A nurse will check their vital signs.

      Participants will have a simple eye exam.

      They will give blood and urine samples.

      Participants will be connected to equipment. This will collect data while they look at
      pictures.

      Then they will have a 10-minute break. A nurse will observe them during the break.

      Participants will have their breath analyzed.

      Participants will answer questions. The topics will include:

      Education

      Job

      Income

      Family history

      Tobacco use

      Exposure to pro-smoking and anti-smoking messages

      History of drug and alcohol use
Smoking remains a public health problem in the US, and cigarette marketing has been concluded
      as one of the causal factors for the epidemic. Previous studies on cigarette direct mail
      marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there
      is a need for a study that would provide a stronger evidence on how direct mail marketing
      influences smoking behavior. The proposed study will consist of two parts where pilot data
      are to be collected in Part 1, and further data are to be collected in Part 2 conducted as a
      randomized comparative trial. Up to a total of 530 healthy volunteers ages 18-29 are to be
      recruited for the study. After meeting the eligibility and enrolling onto the study,
      participants will have their biospecimens collected followed by an experiment in which they
      are to be shown images on the computer. Study participants will then take a break and
      afterwards will provide additional sociodemographic and psychosocial information through an
      audio computer assisted self-administered interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.
time frame: 1 Day
description: Measure of physiological responses.
measure: To conduct a randomized comparative trial to examine the effect of cigarette direct mail materials on beliefs, affective responses, arousal, and smoking behavior, and their variation by SES among young adult smokers.
time frame: 1 Day
description: Measure of physiological responses.
measure: To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.
time frame: 1 Day
description: Measure of physiological responses.
arm group label: 1/Part 1
arm group type: Experimental
description: 60 Participants of high and low SES
arm group label: 2/Part 2 - Discount Coupons
arm group type: Experimental
description: Randomized to view direct mail marketing
arm group label: 3/Part 2 - No Discount Coupons
arm group type: Experimental
description: Randomized to view direct mail marketing
arm group label: 4/Part 2 - Control
arm group type: Experimental
description: Randomized to view direct mail marketing
intervention type: Behavioral
intervention name: Exposure to smoking advertising with coupon
description: Direct mail marketing of smoking advertising with discount coupon
arm group label: 2/Part 2 - Discount Coupons
intervention type: Behavioral
intervention name: Exposure to smoking advertising without coupons
description: Direct mail marketing of smoking advertising without discount coupon
arm group label: 3/Part 2 - No Discount Coupons
intervention type: Behavioral
intervention name: Exposure to non health related images
description: Control group
arm group label: 1/Part 1
arm group label: 4/Part 2 - Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
last name: Tsz (Kelvin) C Choi, Ph.D.
role: Principal Investigator
affiliation: National Institute on Minority Health and Health Disparities (NIMHD)
last name: Bambi JE Jewett
phone: (301) 827-0493
email: bambi.jewett@nih.gov
last name: Tsz (Kelvin) C Choi, Ph.D.
phone: (301) 496-3400
email: tsz.choi@nih.gov
facility: 
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-MD-0015.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Tobacco Use Disorder