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/NCT05973981</url>
    </required_header>
    <id_info>
      <org_study_id>R01CA261639</org_study_id>
      <nct_id>NCT05973981</nct_id>
    </id_info>
    <brief_title>The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment</brief_title>
    <official_title>The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RAND</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RAND</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>
        The overall aim of this research is to experimentally evaluate the extent to which partially&#xD;
        standardizing the color of tobacco packaging influences tobacco use intentions among young&#xD;
        adults who have varying levels of tobacco use experience.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 4, 2022</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2026</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>Factorial Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quit smoking motivation</measure>
      <time_frame>Immediately after shopping in the RAND StoreLab</time_frame>
      <description>Motivation to quit smoking as assessed by the Motivation to Stop Scale (MTSS; Kotz et al., 2013; Drug and Alcohol Dependence) participants endorsing one of 7 items: I don't want to stop smoking.&#xD;
  I think I should stop smoking but don't really want to. I want to stop smoking but haven't thought about when. I REALLY want to stop smoking but I don't know when I will. I want to stop smoking and hope to soon. I REALLY want to stop smoking and intend to in the next 3 months. I REALLY want to stop smoking and intend to in the next month.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Smoking, Cigarette</condition>
    <arm_group>
      <arm_group_label>Status Quo Packages</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Cigarette packages appear as they normally do - no standardization</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Partial standardization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cigarette packages appear with half of the package using a standardized color</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Full standardization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cigarette packages appear with all of the packages fully standardized (by color and font)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Package standardization</intervention_name>
      <description>Conditions vary in terms of amount of cigarette packages that are subject to standardization</description>
      <arm_group_label>Full standardization</arm_group_label>
      <arm_group_label>Partial standardization</arm_group_label>
      <arm_group_label>Status Quo Packages</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 21-29&#xD;
  &#xD;
            -  Past month cigarette smoker&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>29 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>RAND Corporation</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>
  
  
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/NCT05973981
  org study id: R01CA261639
  nct id: NCT05973981
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The overall aim of this research is to experimentally evaluate the extent to which partially
        standardizing the color of tobacco packaging influences tobacco use intentions among young
        adults who have varying levels of tobacco use experience.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Quit smoking motivation
  time frame: Immediately after shopping in the RAND StoreLab
  description: Motivation to quit smoking as assessed by the Motivation to Stop Scale (MTSS; Kotz et al., 2013; Drug and Alcohol Dependence) participants endorsing one of 7 items: I don't want to stop smoking.
  I think I should stop smoking but don't really want to. I want to stop smoking but haven't thought about when. I REALLY want to stop smoking but I don't know when I will. I want to stop smoking and hope to soon. I REALLY want to stop smoking and intend to in the next 3 months. I REALLY want to stop smoking and intend to in the next month.
  arm group label: Status Quo Packages
  arm group type: Active Comparator
  description: Cigarette packages appear as they normally do - no standardization
  arm group label: Partial standardization
  arm group type: Experimental
  description: Cigarette packages appear with half of the package using a standardized color
  arm group label: Full standardization
  arm group type: Experimental
  description: Cigarette packages appear with all of the packages fully standardized (by color and font)
  intervention type: Behavioral
  intervention name: Package standardization
  description: Conditions vary in terms of amount of cigarette packages that are subject to standardization
  arm group label: Full standardization
  arm group label: Partial standardization
  arm group label: Status Quo Packages
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 29 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No