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Impact of Graphic Cigarette Warnings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247908
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Smoking Other: Surgeon General's Warning Other: Graphic Warning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
Study Start Date : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Graphic Warning
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.
Other: Graphic Warning

Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks:

  1. Text: "WARNING: Cigarettes are addictive." Image: Man smoking through tracheotomy hole.
  2. Text: "WARNING: Cigarettes causes fatal lung disease." Image: Healthy lungs next to diseased lungs.
  3. Text: "WARNING: Cigarettes cause cancer." Image: Mouth with cancerous lesion on lip.
  4. Text: "WARNING: Smoking can kill you." Image: Woman dying from cancer.

Active Comparator: Surgeon General's Warning
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.
Other: Surgeon General's Warning

Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks:

  1. SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
  2. SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
  3. SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.
  4. SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.




Primary Outcome Measures :
  1. Quit attempts [ Time Frame: Up to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in quit intentions [ Time Frame: 4 weeks ]
    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).

  2. Successful Quitting [ Time Frame: 4 weeks ]
    Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.

  3. Change in forgoing a cigarette [ Time Frame: 4 weeks ]
    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.

  4. Change in positive reinforcement attitudes [ Time Frame: 4 weeks ]
    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).

  5. Change in negative reinforcement attitudes [ Time Frame: 4 weeks ]
    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).

  6. Change in perceived likelihood [ Time Frame: 4 weeks ]
    Perceived likelihood of developing smoking-related health outcomes will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.

  7. Change in frequency of conversations about warning labels [ Time Frame: 4 weeks ]
    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.

  8. Fear [ Time Frame: 4 weeks ]
    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).

  9. Cognitive elaboration [ Time Frame: 4 weeks ]
    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).


Other Outcome Measures:
  1. Change in smoking quantity [ Time Frame: 4 weeks ]
    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).

  2. Change in cessation aid use [ Time Frame: 4 weeks ]
    Use of cessation aids will be measured at baseline pretest, 1, 2, 3, and 4 weeks.

  3. Change in e-cigarette use frequency [ Time Frame: 4 weeks ]
    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).

  4. Initiation of e-cigarette use [ Time Frame: 4 weeks ]
    Among never users of e-cigarettes at baseline pretest, initiation of e-cigarette use will be measured at 4 weeks.

  5. Change in quit stage [ Time Frame: 4 weeks ]
    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.

  6. Change in implementation intentions [ Time Frame: 4 weeks ]
    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.

  7. Change in perceived severity [ Time Frame: 4 weeks ]
    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).

  8. Change in anticipated regret [ Time Frame: 4 weeks ]
    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.

  9. Change in costs of quitting [ Time Frame: 4 weeks ]
    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).

  10. Change in benefits of quitting [ Time Frame: 4 weeks ]
    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).

  11. Change in response efficacy [ Time Frame: 4 weeks ]
    The response efficacy of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.

  12. Change in smoking cons [ Time Frame: 4 weeks ]
    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).

  13. Change in worry [ Time Frame: 4 weeks ]
    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).

  14. Change in self-efficacy to quit smoking [ Time Frame: 4 weeks ]
    Self-efficacy to quit smoking will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Armitage (2007).

  15. Change in pack attitudes [ Time Frame: 4 weeks ]
    Pack attitudes will be measured at baseline pretest and 4 weeks using measures adapted from Moodie (2011).

  16. Change in smoker prototypes [ Time Frame: 4 weeks ]
    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).

  17. Change in e-cigarette user prototypes [ Time Frame: 4 weeks ]
    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).

  18. Change in subjective norms [ Time Frame: 4 weeks ]
    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).

  19. Social reactions [ Time Frame: 4 weeks ]
    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.

  20. Perceived effectiveness [ Time Frame: 4 weeks ]
    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).

  21. Avoidance [ Time Frame: 4 weeks ]
    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.

  22. Reactance [ Time Frame: 4 weeks ]
    Reactance to the warning label will be measured at baseline posttest, 1 and 4 weeks using a scale developed by the investigators.

  23. Emotional reactions [ Time Frame: 4 weeks ]
    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).

  24. Perceived understandability [ Time Frame: 4 weeks ]
    Perceived understandability will be measured at baseline posttest and 4 weeks using a measure adapted from Cameron, Pepper, and Brewer (2013).

  25. Attention/noticing [ Time Frame: 4 weeks ]
    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).

  26. Recall [ Time Frame: 4 weeks ]
    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.

  27. Recognition [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 18 years or older
  • Have smoked at least 100 cigarettes in his or her lifetime
  • Currently smoke cigarettes
  • Be able to read and speak English

Exclusion Criteria:

  • Pregnant women
  • Smokers who smoke exclusively roll-your-own cigarettes
  • Smokers concurrently enrolled in another cessation study
  • Smokers who smoke fewer than 7 cigarettes per week, on average
  • Smokers who live in the same household as someone who has enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247908


Locations
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United States, California
Prevention Research Center of the Pacific Institute for Research & Evaluation
Oakland, California, United States, 94612
United States, North Carolina
Pacific Institute for Research and Evaluation
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Noel Brewer, PhD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02247908    
Other Study ID Numbers: 13-2861
3P30CA016086-38S2 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No patient level data will be shared with the general public or other researchers.
Keywords provided by University of North Carolina, Chapel Hill:
Cigarette smoking
Smoke
Smoking
Tobacco Use