<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/NCT02247908</url>
  </required_header>
  <id_info>
    <org_study_id>13-2861</org_study_id>
    <secondary_id>3P30CA016086-38S2</secondary_id>
    <nct_id>NCT02247908</nct_id>
  </id_info>
  <brief_title>Impact of Graphic Cigarette Warnings</brief_title>
  <official_title>A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized controlled trial is to determine whether graphic health&#xD;
      warnings on cigarette packs are more effective than the existing Surgeon General's warning on&#xD;
      cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate&#xD;
      graphic warnings have been informative, they have used psychological outcomes, such as&#xD;
      attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts).&#xD;
      Furthermore, they typically expose participants to warnings in controlled but artificial&#xD;
      experimental settings for a short period of time, using much lower frequency and shorter&#xD;
      duration of warning exposure than found in the real world. This study addresses these issues&#xD;
      by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have&#xD;
      their cigarette packs labeled with either a graphic warning or a Surgeon General's warning&#xD;
      for four weeks.&#xD;
&#xD;
      Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will&#xD;
      be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized&#xD;
      to receive a Surgeon General's label on their cigarette packs.&#xD;
&#xD;
      Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs&#xD;
      will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon&#xD;
      General's label on their cigarette packs, controlling for baseline quit intentions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette&#xD;
      packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act.&#xD;
      However, tobacco industry litigation has delayed implementation of graphic warnings. A court&#xD;
      ruling that struck down the labels criticized FDA for failing to &quot;present any data - much&#xD;
      less the substantial evidence required under the federal law - showing that enacting their&#xD;
      proposed graphic warnings will accomplish the agency's stated objective of reducing smoking&#xD;
      rates.&quot; This study will address this critique head-on by rigorously testing the impact of the&#xD;
      graphic warnings on quit attempts in a randomized control trial.&#xD;
&#xD;
      Recruitment: Smokers will first undergo screening online or call the study center to complete&#xD;
      the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5&#xD;
      in-person visits. For each of their first 4 visits, smokers will be asked to bring the number&#xD;
      of cigarettes they expect to smoke in an 8 day period.&#xD;
&#xD;
      Informed Consent: Prior to consenting smokers, research staff will visually inspect photo&#xD;
      identification of smokers who report or appear to be under age 27. At the beginning of the&#xD;
      first appointment, study personnel will explain the consent form and ask the smoker to read&#xD;
      the form. Once the participant has finished reading the form, the study personnel member will&#xD;
      ask the participant if he or she has any questions. Then both parties will sign the consent&#xD;
      form and the participant will receive a copy of the consent form.&#xD;
&#xD;
      Randomization: After smokers have consented to participating in the study, study personnel&#xD;
      will randomly assign them to a condition. The investigators will determine the randomization&#xD;
      order a priori. Smokers have an equal chance of being randomized to receive one of four&#xD;
      graphic warnings or one of four Surgeon General's warnings. They will receive the same&#xD;
      warning on their packs during the study.&#xD;
&#xD;
      Assessment: Participants will complete 6 computer-based surveys during the study. The first&#xD;
      appointment will take around 60 minutes and each subsequent visit will take around 30-45&#xD;
      minutes to complete. At their first visit, they will complete a &quot;baseline pre-test,&quot; after&#xD;
      which study personnel will show participants one of their cigarette packs with the assigned&#xD;
      warning. Participants will be allowed to examine the pack. They will then return the pack to&#xD;
      the study personnel and complete a &quot;baseline post-test.&quot; At the next 3 appointments,&#xD;
      participants will complete only one survey and their packs will be labeled. At the final&#xD;
      appointment, they will only complete a survey.&#xD;
&#xD;
      Detailed description of the intervention: While participants are taking the survey, research&#xD;
      staff will apply study warning labels to participants' cigarette packs during the first 4&#xD;
      visits. Participants assigned to the graphic warning condition will receive one of four&#xD;
      graphic warning labels that will be applied and cover the top half of the front and back of&#xD;
      their cigarette packs. The text for the graphic warnings was selected from the 2009 Family&#xD;
      Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA.&#xD;
      Participants in the Surgeon General's warning condition will receive one of four Surgeon&#xD;
      General's Warnings that will be placed on the side of their packs on top of the Surgeon&#xD;
      General's warning printed by the manufacturer. This procedure for the control condition is&#xD;
      intended to control for the effects of labeling. The investigators will instruct participants&#xD;
      in both conditions to use cigarettes from these labeled packs while they are in the study.&#xD;
      Each week they will bring in 8 days' of cigarettes (one extra day to provide a buffer in case&#xD;
      of rescheduled appointments or smoking more than anticipated) for labeling. Additionally,&#xD;
      they will bring in any unused labeled packs from the previous appointment. The investigators&#xD;
      will assess how many cigarettes participants smoke from labeled (i.e., study) and unlabeled&#xD;
      (i.e., non-study) packs to calculate intervention dose (% of cigarettes smoked from labeled&#xD;
      packs). At the end of the study, participants will receive a list of cessation resources.&#xD;
      During the final appointment, participants will also report whether they knew anyone else in&#xD;
      the study or saw another participant's labels, to assess potential contamination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quit intentions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quit intentions will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using the 3-item quit intention scale developed by Klein, Zajac, and Monin (2009).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful Quitting</measure>
    <time_frame>4 weeks</time_frame>
    <description>Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forgoing a cigarette</measure>
    <time_frame>4 weeks</time_frame>
    <description>Forgoing a cigarette will be measured at baseline pretest, 1, 2, 3, and 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less, using measures developed by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in positive reinforcement attitudes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Positive reinforcement attitudes smoking attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon &amp; Baker (1991).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in negative reinforcement attitudes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Negative reinforcement attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon &amp; Baker (1991).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived likelihood</measure>
    <time_frame>4 weeks</time_frame>
    <description>Perceived likelihood of developing smoking-related health outcomes will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frequency of conversations about warning labels</measure>
    <time_frame>4 weeks</time_frame>
    <description>Frequency of conversations with other about the warning labels, health effects of smoking and quitting in the past week will be measured at baseline pretest, 1, 2, 3, and 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fear will be measured at baseline posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from Nonnemaker et al. (2010), Leshner et al. (2011), Watson et al. (1988), and Keller and Block (1996).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive elaboration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Cognitive elaboration will be measured at 1, 2, 3, and 4 weeks adapted from the Depth of Cognitive Processing Scale (Hammond, Fong, McDonald, Cameron, and Brown, 2003) and measures adapted from Fathelrahman et al (2010).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in smoking quantity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Smoking quantity will be measured at baseline pretest, 1, 2, 3, and 4 weeks as the self-reported average number of cigarettes smoked per day during the past week. This measure is adapted from the Population Assessment of Tobacco and Health (PATH) Study (2013).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in cessation aid use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Use of cessation aids will be measured at baseline pretest, 1, 2, 3, and 4 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in e-cigarette use frequency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Frequency of e-cigarette use will be measured at 1, 2, 3, and 4 weeks as the number of days of use in the last 7 days. This measure is adapted from the Population Assessment of Tobacco and Health (PATH) Study (2013).</description>
  </other_outcome>
  <other_outcome>
    <measure>Initiation of e-cigarette use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Among never users of e-cigarettes at baseline pretest, initiation of e-cigarette use will be measured at 4 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in quit stage</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quit stage will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using a measure adapted from the International Tobacco Control (ITC) Policy Evaluation Survey.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in implementation intentions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Implementation intentions will be measured at baseline pretest and 4 weeks to assess how much participants have planned when to quit, how to quit, and how to deal with cravings after quitting.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in perceived severity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Perceived severity of developing various smoking-related health outcomes and of developing quitting side effects will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Lyna (2002).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in anticipated regret</measure>
    <time_frame>4 weeks</time_frame>
    <description>Anticipated regret of continuing to smoke and anticipated regret of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in costs of quitting</measure>
    <time_frame>4 weeks</time_frame>
    <description>Costs of quitting will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from McKee, O'Malley, Salovey, Krishnan-Sarin, and Mazure (2005).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in benefits of quitting</measure>
    <time_frame>4 weeks</time_frame>
    <description>Benefits of quitting will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from McKee, O'Malley, Salovey, Krishnan-Sarin, and Mazure (2005).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in response efficacy</measure>
    <time_frame>4 weeks</time_frame>
    <description>The response efficacy of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in smoking cons</measure>
    <time_frame>4 weeks</time_frame>
    <description>Cons of smoking will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon &amp; Baker (1991) and items from Velicer (1985).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in worry</measure>
    <time_frame>4 weeks</time_frame>
    <description>Worry about the consequences of smoking will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from Dijkstra (2003), Ranby (2013) and Magnan (2009 and 2013).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-efficacy to quit smoking</measure>
    <time_frame>4 weeks</time_frame>
    <description>Self-efficacy to quit smoking will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Armitage (2007).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in pack attitudes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pack attitudes will be measured at baseline pretest and 4 weeks using measures adapted from Moodie (2011).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in smoker prototypes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Positive and negative smoker prototypes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from the smoker prototype scale developed by McCool, Cameron, et al. (2010).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in e-cigarette user prototypes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Positive and negative e-cigarette user prototypes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from the smoker prototype scale developed by McCool, Cameron, et al. (2010).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in subjective norms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjective norms about smoking cessation will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from Armitage (2007) and Von Dras (2004).</description>
  </other_outcome>
  <other_outcome>
    <measure>Social reactions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Social reactions to the warning labels will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures developed by the the investigators to assess the nature, recipient and mode of communication about the warning labels, quitting smoking, and the health effects of smoking.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived effectiveness</measure>
    <time_frame>4 weeks</time_frame>
    <description>Perceived effectiveness of the warning labels will be measured at baseline post-test and 4 weeks using measures adapted from Hitchman, Driezen, Logel, Hammond, and Fong (2013), Trasher et al. (2012) &amp; Cantrell et al (2013).</description>
  </other_outcome>
  <other_outcome>
    <measure>Avoidance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Avoidance of the warning label will be measured 1, 2, 3, and 4 weeks using measures adapted from the Population Assessment of Tobacco and Health Study (2014) and the Environics Research Group (2008), as well as measures developed by the investigators.</description>
  </other_outcome>
  <other_outcome>
    <measure>Reactance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Reactance to the warning label will be measured at baseline posttest, 1 and 4 weeks using a scale developed by the investigators.</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional reactions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Emotional reactions (i.e., anxiety, disgust, sadness, guilt, anger) will be measured at baseline posttest, 1, 2, 3, and 4 weeks using 12 items developed by the investigators and adapted from Nonnemaker et al. (2010), Leshner et al. (2011), Watson et al. (1988), and Keller and Block (1996).</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived understandability</measure>
    <time_frame>4 weeks</time_frame>
    <description>Perceived understandability will be measured at baseline posttest and 4 weeks using a measure adapted from Cameron, Pepper, and Brewer (2013).</description>
  </other_outcome>
  <other_outcome>
    <measure>Attention/noticing</measure>
    <time_frame>4 weeks</time_frame>
    <description>Attention/noticing of labels will be measured at baseline posttest, 1, 2, 3, and 4 weeks using measures adapted from Fathelrahman et al. (2010) and Nonnemaker et al. (2010).</description>
  </other_outcome>
  <other_outcome>
    <measure>Recall</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants will be randomly assigned to be assessed unprompted recall of the image and text of their assigned warning label at 1, 2, 3 or 4 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recognition</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants will be randomly assigned to be assessed recognition of the image and text of their assigned warning label at either 1, 2, 3, or 4 weeks.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2149</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Graphic Warning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Graphic warnings that include text and an image depicting a health effect of smoking will be applied on labels that cover the top half of the front and back of participants' cigarette packs each week for 4 weeks. Within the graphic warning condition, participants will be assigned to receive 1 of 4 warnings for 4 weeks. The text for these warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgeon General's Warning</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Labels with Surgeon General's Warning text will be applied to the side of participants' cigarette packs each week for 4 weeks, on top of the Surgeon General's Warning printed by the manufacturer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surgeon General's Warning</intervention_name>
    <description>Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks:&#xD;
SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.&#xD;
SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.&#xD;
SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.&#xD;
SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.</description>
    <arm_group_label>Surgeon General's Warning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Graphic Warning</intervention_name>
    <description>Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks:&#xD;
Text: &quot;WARNING: Cigarettes are addictive.&quot; Image: Man smoking through tracheotomy hole.&#xD;
Text: &quot;WARNING: Cigarettes causes fatal lung disease.&quot; Image: Healthy lungs next to diseased lungs.&#xD;
Text: &quot;WARNING: Cigarettes cause cancer.&quot; Image: Mouth with cancerous lesion on lip.&#xD;
Text: &quot;WARNING: Smoking can kill you.&quot; Image: Woman dying from cancer.</description>
    <arm_group_label>Graphic Warning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 years or older&#xD;
&#xD;
          -  Have smoked at least 100 cigarettes in his or her lifetime&#xD;
&#xD;
          -  Currently smoke cigarettes&#xD;
&#xD;
          -  Be able to read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Smokers who smoke exclusively roll-your-own cigarettes&#xD;
&#xD;
          -  Smokers concurrently enrolled in another cessation study&#xD;
&#xD;
          -  Smokers who smoke fewer than 7 cigarettes per week, on average&#xD;
&#xD;
          -  Smokers who live in the same household as someone who has enrolled in the study&#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>
  <overall_official>
    <last_name>Noel Brewer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prevention Research Center of the Pacific Institute for Research &amp; Evaluation</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Institute for Research and Evaluation</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 12, 2016</last_update_submitted>
  <last_update_submitted_qc>September 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cigarette smoking</keyword>
  <keyword>Smoke</keyword>
  <keyword>Smoking</keyword>
  <keyword>Tobacco Use</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No patient level data will be shared with the general public or other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT02247908
org study id: 13-2861
secondary id: 3P30CA016086-38S2
nct id: NCT02247908
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this randomized controlled trial is to determine whether graphic health
      warnings on cigarette packs are more effective than the existing Surgeon General's warning on
      cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate
      graphic warnings have been informative, they have used psychological outcomes, such as
      attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts).
      Furthermore, they typically expose participants to warnings in controlled but artificial
      experimental settings for a short period of time, using much lower frequency and shorter
      duration of warning exposure than found in the real world. This study addresses these issues
      by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have
      their cigarette packs labeled with either a graphic warning or a Surgeon General's warning
      for four weeks.

      Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will
      be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized
      to receive a Surgeon General's label on their cigarette packs.

      Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs
      will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon
      General's label on their cigarette packs, controlling for baseline quit intentions.
The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette
      packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act.
      However, tobacco industry litigation has delayed implementation of graphic warnings. A court
      ruling that struck down the labels criticized FDA for failing to "present any data - much
      less the substantial evidence required under the federal law - showing that enacting their
      proposed graphic warnings will accomplish the agency's stated objective of reducing smoking
      rates." This study will address this critique head-on by rigorously testing the impact of the
      graphic warnings on quit attempts in a randomized control trial.

      Recruitment: Smokers will first undergo screening online or call the study center to complete
      the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5
      in-person visits. For each of their first 4 visits, smokers will be asked to bring the number
      of cigarettes they expect to smoke in an 8 day period.

      Informed Consent: Prior to consenting smokers, research staff will visually inspect photo
      identification of smokers who report or appear to be under age 27. At the beginning of the
      first appointment, study personnel will explain the consent form and ask the smoker to read
      the form. Once the participant has finished reading the form, the study personnel member will
      ask the participant if he or she has any questions. Then both parties will sign the consent
      form and the participant will receive a copy of the consent form.

      Randomization: After smokers have consented to participating in the study, study personnel
      will randomly assign them to a condition. The investigators will determine the randomization
      order a priori. Smokers have an equal chance of being randomized to receive one of four
      graphic warnings or one of four Surgeon General's warnings. They will receive the same
      warning on their packs during the study.

      Assessment: Participants will complete 6 computer-based surveys during the study. The first
      appointment will take around 60 minutes and each subsequent visit will take around 30-45
      minutes to complete. At their first visit, they will complete a "baseline pre-test," after
      which study personnel will show participants one of their cigarette packs with the assigned
      warning. Participants will be allowed to examine the pack. They will then return the pack to
      the study personnel and complete a "baseline post-test." At the next 3 appointments,
      participants will complete only one survey and their packs will be labeled. At the final
      appointment, they will only complete a survey.

      Detailed description of the intervention: While participants are taking the survey, research
      staff will apply study warning labels to participants' cigarette packs during the first 4
      visits. Participants assigned to the graphic warning condition will receive one of four
      graphic warning labels that will be applied and cover the top half of the front and back of
      their cigarette packs. The text for the graphic warnings was selected from the 2009 Family
      Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA.
      Participants in the Surgeon General's warning condition will receive one of four Surgeon
      General's Warnings that will be placed on the side of their packs on top of the Surgeon
      General's warning printed by the manufacturer. This procedure for the control condition is
      intended to control for the effects of labeling. The investigators will instruct participants
      in both conditions to use cigarettes from these labeled packs while they are in the study.
      Each week they will bring in 8 days' of cigarettes (one extra day to provide a buffer in case
      of rescheduled appointments or smoking more than anticipated) for labeling. Additionally,
      they will bring in any unused labeled packs from the previous appointment. The investigators
      will assess how many cigarettes participants smoke from labeled (i.e., study) and unlabeled
      (i.e., non-study) packs to calculate intervention dose (% of cigarettes smoked from labeled
      packs). At the end of the study, participants will receive a list of cessation resources.
      During the final appointment, participants will also report whether they knew anyone else in
      the study or saw another participant's labels, to assess potential contamination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Quit attempts
time frame: Up to 4 weeks
description: The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.
measure: Change in quit intentions
time frame: 4 weeks
description: Quit intentions will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using the 3-item quit intention scale developed by Klein, Zajac, and Monin (2009).
measure: Successful Quitting
time frame: 4 weeks
description: Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.
measure: Change in forgoing a cigarette
time frame: 4 weeks
description: Forgoing a cigarette will be measured at baseline pretest, 1, 2, 3, and 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less, using measures developed by the investigators.
measure: Change in positive reinforcement attitudes
time frame: 4 weeks
description: Positive reinforcement attitudes smoking attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon & Baker (1991).
measure: Change in negative reinforcement attitudes
time frame: 4 weeks
description: Negative reinforcement attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon & Baker (1991).
measure: Change in perceived likelihood
time frame: 4 weeks
description: Perceived likelihood of developing smoking-related health outcomes will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.
measure: Change in frequency of conversations about warning labels
time frame: 4 weeks
description: Frequency of conversations with other about the warning labels, health effects of smoking and quitting in the past week will be measured at baseline pretest, 1, 2, 3, and 4 weeks.
measure: Fear
time frame: 4 weeks
description: Fear will be measured at baseline posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from Nonnemaker et al. (2010), Leshner et al. (2011), Watson et al. (1988), and Keller and Block (1996).
measure: Cognitive elaboration
time frame: 4 weeks
description: Cognitive elaboration will be measured at 1, 2, 3, and 4 weeks adapted from the Depth of Cognitive Processing Scale (Hammond, Fong, McDonald, Cameron, and Brown, 2003) and measures adapted from Fathelrahman et al (2010).
measure: Change in smoking quantity
time frame: 4 weeks
description: Smoking quantity will be measured at baseline pretest, 1, 2, 3, and 4 weeks as the self-reported average number of cigarettes smoked per day during the past week. This measure is adapted from the Population Assessment of Tobacco and Health (PATH) Study (2013).
measure: Change in cessation aid use
time frame: 4 weeks
description: Use of cessation aids will be measured at baseline pretest, 1, 2, 3, and 4 weeks.
measure: Change in e-cigarette use frequency
time frame: 4 weeks
description: Frequency of e-cigarette use will be measured at 1, 2, 3, and 4 weeks as the number of days of use in the last 7 days. This measure is adapted from the Population Assessment of Tobacco and Health (PATH) Study (2013).
measure: Initiation of e-cigarette use
time frame: 4 weeks
description: Among never users of e-cigarettes at baseline pretest, initiation of e-cigarette use will be measured at 4 weeks.
measure: Change in quit stage
time frame: 4 weeks
description: Quit stage will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using a measure adapted from the International Tobacco Control (ITC) Policy Evaluation Survey.
measure: Change in implementation intentions
time frame: 4 weeks
description: Implementation intentions will be measured at baseline pretest and 4 weeks to assess how much participants have planned when to quit, how to quit, and how to deal with cravings after quitting.
measure: Change in perceived severity
time frame: 4 weeks
description: Perceived severity of developing various smoking-related health outcomes and of developing quitting side effects will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Lyna (2002).
measure: Change in anticipated regret
time frame: 4 weeks
description: Anticipated regret of continuing to smoke and anticipated regret of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.
measure: Change in costs of quitting
time frame: 4 weeks
description: Costs of quitting will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from McKee, O'Malley, Salovey, Krishnan-Sarin, and Mazure (2005).
measure: Change in benefits of quitting
time frame: 4 weeks
description: Benefits of quitting will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from McKee, O'Malley, Salovey, Krishnan-Sarin, and Mazure (2005).
measure: Change in response efficacy
time frame: 4 weeks
description: The response efficacy of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.
measure: Change in smoking cons
time frame: 4 weeks
description: Cons of smoking will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon & Baker (1991) and items from Velicer (1985).
measure: Change in worry
time frame: 4 weeks
description: Worry about the consequences of smoking will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from Dijkstra (2003), Ranby (2013) and Magnan (2009 and 2013).
measure: Change in self-efficacy to quit smoking
time frame: 4 weeks
description: Self-efficacy to quit smoking will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Armitage (2007).
measure: Change in pack attitudes
time frame: 4 weeks
description: Pack attitudes will be measured at baseline pretest and 4 weeks using measures adapted from Moodie (2011).
measure: Change in smoker prototypes
time frame: 4 weeks
description: Positive and negative smoker prototypes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from the smoker prototype scale developed by McCool, Cameron, et al. (2010).
measure: Change in e-cigarette user prototypes
time frame: 4 weeks
description: Positive and negative e-cigarette user prototypes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from the smoker prototype scale developed by McCool, Cameron, et al. (2010).
measure: Change in subjective norms
time frame: 4 weeks
description: Subjective norms about smoking cessation will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures adapted from Armitage (2007) and Von Dras (2004).
measure: Social reactions
time frame: 4 weeks
description: Social reactions to the warning labels will be measured at baseline pretest, 1, 2, 3, and 4 weeks using measures developed by the the investigators to assess the nature, recipient and mode of communication about the warning labels, quitting smoking, and the health effects of smoking.
measure: Perceived effectiveness
time frame: 4 weeks
description: Perceived effectiveness of the warning labels will be measured at baseline post-test and 4 weeks using measures adapted from Hitchman, Driezen, Logel, Hammond, and Fong (2013), Trasher et al. (2012) & Cantrell et al (2013).
measure: Avoidance
time frame: 4 weeks
description: Avoidance of the warning label will be measured 1, 2, 3, and 4 weeks using measures adapted from the Population Assessment of Tobacco and Health Study (2014) and the Environics Research Group (2008), as well as measures developed by the investigators.
measure: Reactance
time frame: 4 weeks
description: Reactance to the warning label will be measured at baseline posttest, 1 and 4 weeks using a scale developed by the investigators.
measure: Emotional reactions
time frame: 4 weeks
description: Emotional reactions (i.e., anxiety, disgust, sadness, guilt, anger) will be measured at baseline posttest, 1, 2, 3, and 4 weeks using 12 items developed by the investigators and adapted from Nonnemaker et al. (2010), Leshner et al. (2011), Watson et al. (1988), and Keller and Block (1996).
measure: Perceived understandability
time frame: 4 weeks
description: Perceived understandability will be measured at baseline posttest and 4 weeks using a measure adapted from Cameron, Pepper, and Brewer (2013).
measure: Attention/noticing
time frame: 4 weeks
description: Attention/noticing of labels will be measured at baseline posttest, 1, 2, 3, and 4 weeks using measures adapted from Fathelrahman et al. (2010) and Nonnemaker et al. (2010).
measure: Recall
time frame: 4 weeks
description: Participants will be randomly assigned to be assessed unprompted recall of the image and text of their assigned warning label at 1, 2, 3 or 4 weeks.
measure: Recognition
time frame: 4 weeks
description: Participants will be randomly assigned to be assessed recognition of the image and text of their assigned warning label at either 1, 2, 3, or 4 weeks.
arm group label: Graphic Warning
arm group type: Experimental
description: Graphic warnings that include text and an image depicting a health effect of smoking will be applied on labels that cover the top half of the front and back of participants' cigarette packs each week for 4 weeks. Within the graphic warning condition, participants will be assigned to receive 1 of 4 warnings for 4 weeks. The text for these warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA.
arm group label: Surgeon General's Warning
arm group type: Active Comparator
description: Labels with Surgeon General's Warning text will be applied to the side of participants' cigarette packs each week for 4 weeks, on top of the Surgeon General's Warning printed by the manufacturer.
intervention type: Other
intervention name: Surgeon General's Warning
description: Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks:
SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.
SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.
arm group label: Surgeon General's Warning
intervention type: Other
intervention name: Graphic Warning
description: Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks:
Text: "WARNING: Cigarettes are addictive." Image: Man smoking through tracheotomy hole.
Text: "WARNING: Cigarettes causes fatal lung disease." Image: Healthy lungs next to diseased lungs.
Text: "WARNING: Cigarettes cause cancer." Image: Mouth with cancerous lesion on lip.
Text: "WARNING: Smoking can kill you." Image: Woman dying from cancer.
arm group label: Graphic Warning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noel Brewer, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No patient level data will be shared with the general public or other researchers.