<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/NCT02261363</url>
  </required_header>
  <id_info>
    <org_study_id>00008526</org_study_id>
    <nct_id>NCT02261363</nct_id>
  </id_info>
  <brief_title>The Moment Study: Mixed Method Ecigarette Study</brief_title>
  <acronym>Moment</acronym>
  <official_title>A Mixed Method EMA Assessment of Cognition and Behavior Among New ENDS Users: An Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Truth Initiative</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Truth Initiative</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The universe of tobacco products is expanding, with new noncombustible products gaining&#xD;
      popularity even as the reduction in prevalence of cigarette smoking slows or stalls.&#xD;
      E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these&#xD;
      emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary&#xD;
      delivery devices under development, ENDS are likely to play an increasing role in the future&#xD;
      tobacco market. Little is known about the cognitions and behaviors leading to or sustaining&#xD;
      ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking&#xD;
      harms, or for smoking cessation. Evidence about ENDS use is emerging from national&#xD;
      surveillance and laboratory research, but the majority of information on ENDS is limited to&#xD;
      retrospective surveys and convenience samples of White male ENDS users. The investigators&#xD;
      research suggests Black smokers are less likely than White smokers to try and be current ENDS&#xD;
      users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference&#xD;
      for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers,&#xD;
      including Blacks and menthol smokers, experience and initiate ENDS use employing valid,&#xD;
      innovative research methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cigarette use</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Ecological momentary assessment data through cell phone text messaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ecigarette use</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Ecological momentary assessment data through cell phone text messaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motivation to Quit</measure>
    <time_frame>30 day follow up</time_frame>
    <description>Stage of Change Model</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Ecig group 1</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Ecig group 2</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In total, our goal is to enroll 150 individuals, with 120 participants completing the&#xD;
        protocol. For the main arm of the study, we will recruit a racially and ethnically diverse&#xD;
        sample of 140 daily smokers (or 100 study completers), with the goal of recruiting at least&#xD;
        50% non-Hispanic black participants. For the second study arm, we will enroll an additional&#xD;
        30 participants, with the goal of 20 individuals completing the protocol. There are no&#xD;
        race/ethnicity recruitment goals associated with the second arm. In total, the main study&#xD;
        arm will consist of 100 daily smokers who do not intend to quit smoking in the next 30&#xD;
        days, while the second arm will include 20 daily smokers who do intend to quit smoking in&#xD;
        the next 30 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must:&#xD;
&#xD;
          1. be aged 18 years or older&#xD;
&#xD;
          2. reside in Washington, D.C. metro area (including VA and MD suburbs)&#xD;
&#xD;
          3. be proficient in English&#xD;
&#xD;
          4. be daily smoker with at least 5 years of established daily smoking&#xD;
&#xD;
               -  A person will be categorized as a daily smoker if he reports daily smoking of at&#xD;
                  least 8 cigarettes a day for the past 5 years, and records an exhaled air carbon&#xD;
                  monoxide (CO) level &gt; 8 parts-per-million (ppm) at the baseline in-person&#xD;
                  meeting.&#xD;
&#xD;
               -  Daily smokers will be eligible for the main study if they do not intend to quit&#xD;
                  in the next 30 days.&#xD;
&#xD;
               -  If they do intend to quit in the next 30 days, eligible daily smokers will be&#xD;
                  enrolled in the second arm of the study.&#xD;
&#xD;
          5. not taking smoking cessation medications;&#xD;
&#xD;
          6. smoked LCC/cigars/hookah less than 5 times in last 30 days&#xD;
&#xD;
          7. have not used other tobacco products in last 30 days&#xD;
&#xD;
          8. have not used an ENDS product (electronic cigarette) in the last 30 days&#xD;
&#xD;
          9. be interested in trying an ENDS&#xD;
&#xD;
         10. have an iPhone or Android that allows installation of applications and use it daily&#xD;
&#xD;
         11. have a phone plan that allows unlimited text messages&#xD;
&#xD;
         12. be willing to travel to the data collection cite four times in three weeks&#xD;
&#xD;
         13. not be breastfeeding or planning to become pregnant&#xD;
&#xD;
         14. not have heart disease/uncontrolled blood pressure&#xD;
&#xD;
         15. not have psychosis/suicidal thoughts&#xD;
&#xD;
         16. not be currently enrolled in an alcohol treatment program&#xD;
&#xD;
         17. not be out of town for more than 5 nights in the next 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not satisfy the criteria above will not be eligible for this study.&#xD;
&#xD;
          -  There will be no involvement of vulnerable populations.&#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>
  <location>
    <facility>
      <name>American Legacy Foundation</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>August 18, 2016</last_update_submitted>
  <last_update_submitted_qc>August 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Truth Initiative</investigator_affiliation>
    <investigator_full_name>Jennifer Pearson</investigator_full_name>
    <investigator_title>Research Investigator</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>March 30, 2021</submitted>
    <returned>April 26, 2021</returned>
    <submitted>October 13, 2021</submitted>
    <returned>November 9, 2021</returned>
  </pending_results>
  <!-- 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/NCT02261363
org study id: 00008526
nct id: NCT02261363
lead sponsor: 
has dmc: Yes
The universe of tobacco products is expanding, with new noncombustible products gaining
      popularity even as the reduction in prevalence of cigarette smoking slows or stalls.
      E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these
      emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary
      delivery devices under development, ENDS are likely to play an increasing role in the future
      tobacco market. Little is known about the cognitions and behaviors leading to or sustaining
      ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking
      harms, or for smoking cessation. Evidence about ENDS use is emerging from national
      surveillance and laboratory research, but the majority of information on ENDS is limited to
      retrospective surveys and convenience samples of White male ENDS users. The investigators
      research suggests Black smokers are less likely than White smokers to try and be current ENDS
      users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference
      for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers,
      including Blacks and menthol smokers, experience and initiate ENDS use employing valid,
      innovative research methods.
observational model: Cohort
time perspective: Prospective
measure: Cigarette use
time frame: Weeks 1-3
description: Ecological momentary assessment data through cell phone text messaging
measure: Ecigarette use
time frame: Weeks 1-3
description: Ecological momentary assessment data through cell phone text messaging
measure: Motivation to Quit
time frame: 30 day follow up
description: Stage of Change Model
arm group label: Ecig group 1
arm group label: Ecig group 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Truth Initiative
investigator full name: Jennifer Pearson
investigator title: Research Investigator
submitted: March 30, 2021
returned: April 26, 2021
submitted: October 13, 2021
returned: November 9, 2021