xml: <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/NCT05994209</url>
    </required_header>
    <id_info>
      <org_study_id>1R34DA054725-01A1</org_study_id>
      <secondary_id>R34DA054725</secondary_id>
      <nct_id>NCT05994209</nct_id>
    </id_info>
    <brief_title>Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors</brief_title>
    <official_title>Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been&#xD;
        increasing rapidly, particularly among teens and young adults. With limited information on&#xD;
        the long-term effects of vaping products, health information about vaping has been somewhat&#xD;
        unclear in regards to associated health risks. Teens and young adults may be reluctant to&#xD;
        disclose their use of vaping products to parents or health providers and instead turn to&#xD;
        social media to share and seek out information regarding vaping risks and cessation supports.&#xD;
        Thus, our current proposal outlines the use of social media to identify teens and young&#xD;
        adults socially networking about vaping, the use of an online chatbot screen to evaluate&#xD;
        individual cessation support needs, and the use of a digital intervention system to support&#xD;
        vaping cessation. The mobile intervention used in this study is based on a widely-used&#xD;
        evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been&#xD;
        adapted for vaping and young adults to include an in-app chatbot to guide users to tailored&#xD;
        content and to motivate and encourage their cessation efforts. We aim to integrate our social&#xD;
        media recruitment and online screening approach to connect individuals with this mobile app&#xD;
        intervention, and will conduct a randomized controlled trial to evaluate user engagement with&#xD;
        and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens&#xD;
        and young adults.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 1</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>Vaping cessation</measure>
      <time_frame>Baseline, 6 weeks, 3 months</time_frame>
      <description>Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nicotine dependence</measure>
      <time_frame>Baseline, 6 weeks, 3 months</time_frame>
      <description>Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Risk perception related to vaping</measure>
      <time_frame>Baseline, 6 weeks, 3 months</time_frame>
      <description>Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention engagement</measure>
      <time_frame>Baseline, 6 weeks, 3 months</time_frame>
      <description>Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">189</enrollment>
    <condition>Nicotine Vaping</condition>
    <condition>Nicotine Use Disorder</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Nationwide resource referral and intervention waitlist</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental Group A: Mobile App Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>quitSTART Mobile Application</intervention_name>
      <description>Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.</description>
      <arm_group_label>Experimental Group A: Mobile App Intervention</arm_group_label>
      <arm_group_label>Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  US Resident&#xD;
  &#xD;
            -  English Speaking&#xD;
  &#xD;
            -  Have daily access to a smartphone&#xD;
  &#xD;
            -  Current vaping product user (P30D)&#xD;
  &#xD;
            -  Identified as socially networking about a desire to quit vaping and/or experiencing&#xD;
               negative health outcomes due to vaping&#xD;
  &#xD;
            -  Vaping product user only (i.e., not using vaping as a means to support combustible&#xD;
               smoking cessation)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Patricia Cavazos-Rehg, PhD</last_name>
      <phone>314-362-2152</phone>
      <email>pcavazos@wust.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erin Kasson, MSW</last_name>
      <phone>314-362-9003</phone>
      <email>erinmkasson@wustl.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>vaping</keyword>
    <keyword>mobile app intervention</keyword>
    <keyword>youth</keyword>
    <keyword>young adults</keyword>
    <keyword>chatbot</keyword>
    <keyword>nicotine</keyword>
    <keyword>social media</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tobacco Use Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994209
  org study id: 1R34DA054725-01A1
  secondary id: R34DA054725
  nct id: NCT05994209
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been
        increasing rapidly, particularly among teens and young adults. With limited information on
        the long-term effects of vaping products, health information about vaping has been somewhat
        unclear in regards to associated health risks. Teens and young adults may be reluctant to
        disclose their use of vaping products to parents or health providers and instead turn to
        social media to share and seek out information regarding vaping risks and cessation supports.
        Thus, our current proposal outlines the use of social media to identify teens and young
        adults socially networking about vaping, the use of an online chatbot screen to evaluate
        individual cessation support needs, and the use of a digital intervention system to support
        vaping cessation. The mobile intervention used in this study is based on a widely-used
        evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been
        adapted for vaping and young adults to include an in-app chatbot to guide users to tailored
        content and to motivate and encourage their cessation efforts. We aim to integrate our social
        media recruitment and online screening approach to connect individuals with this mobile app
        intervention, and will conduct a randomized controlled trial to evaluate user engagement with
        and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens
        and young adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Vaping cessation
  time frame: Baseline, 6 weeks, 3 months
  description: Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.
  measure: Nicotine dependence
  time frame: Baseline, 6 weeks, 3 months
  description: Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).
  measure: Risk perception related to vaping
  time frame: Baseline, 6 weeks, 3 months
  description: Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020.
  measure: Intervention engagement
  time frame: Baseline, 6 weeks, 3 months
  description: Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI).
  arm group label: Control Group
  arm group type: No Intervention
  description: Nationwide resource referral and intervention waitlist
  arm group label: Experimental Group A: Mobile App Intervention
  arm group type: Experimental
  description: quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults
  arm group label: Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature
  arm group type: Experimental
  description: quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature
  intervention type: Device
  intervention name: quitSTART Mobile Application
  description: Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.
  arm group label: Experimental Group A: Mobile App Intervention
  arm group label: Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Patricia Cavazos-Rehg, PhD
  phone: 314-362-2152
  email: pcavazos@wust.edu
  last name: Erin Kasson, MSW
  phone: 314-362-9003
  email: erinmkasson@wustl.edu
  responsible party type: Sponsor
  mesh term: Tobacco Use Disorder
  sharing ipd: Undecided