Impact of Graphic Cigarette Warnings

Smoking Clinical Trial

Official title:

A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247908
• Other study ID #: 13-2861
• Secondary ID: 3P30CA016086-38S
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: September 12, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2149
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

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: 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.
• Graphic Warning
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.

Locations

Country	Name	City	State
United States	Pacific Institute for Research and Evaluation	Chapel Hill	North Carolina
United States	Prevention Research Center of the Pacific Institute for Research & Evaluation	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in smoking quantity	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).	4 weeks	No
Other	Change in cessation aid use	Use of cessation aids will be measured at baseline pretest, 1, 2, 3, and 4 weeks.	4 weeks	No
Other	Change in e-cigarette use frequency	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 weeks	No
Other	Initiation of e-cigarette use	Among never users of e-cigarettes at baseline pretest, initiation of e-cigarette use will be measured at 4 weeks.	4 weeks	No
Other	Change in quit stage	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.	4 weeks	No
Other	Change in implementation intentions	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.	4 weeks	No
Other	Change in perceived severity	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).	4 weeks	No
Other	Change in anticipated regret	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.	4 weeks	No
Other	Change in costs of quitting	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).	4 weeks	No
Other	Change in benefits of quitting	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).	4 weeks	No
Other	Change in response efficacy	The response efficacy of quitting smoking will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.	4 weeks	No
Other	Change in smoking cons	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).	4 weeks	No
Other	Change in worry	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).	4 weeks	No
Other	Change in self-efficacy to quit smoking	Self-efficacy to quit smoking will be measured at baseline pretest, 2, and 4 weeks using measures adapted from Armitage (2007).	4 weeks	No
Other	Change in pack attitudes	Pack attitudes will be measured at baseline pretest and 4 weeks using measures adapted from Moodie (2011).	4 weeks	No
Other	Change in smoker prototypes	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).	4 weeks	No
Other	Change in e-cigarette user prototypes	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).	4 weeks	No
Other	Change in subjective norms	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).	4 weeks	No
Other	Social reactions	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.	4 weeks	No
Other	Perceived effectiveness	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).	4 weeks	No
Other	Avoidance	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.	4 weeks	No
Other	Reactance	Reactance to the warning label will be measured at baseline posttest, 1 and 4 weeks using a scale developed by the investigators.	4 weeks	No
Other	Emotional reactions	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).	4 weeks	No
Other	Perceived understandability	Perceived understandability will be measured at baseline posttest and 4 weeks using a measure adapted from Cameron, Pepper, and Brewer (2013).	4 weeks	No
Other	Attention/noticing	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).	4 weeks	No
Other	Recall	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.	4 weeks	No
Other	Recognition	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.	4 weeks	No
Primary	Quit attempts	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.	Up to 4 weeks	No
Secondary	Change in quit intentions	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).	4 weeks	No
Secondary	Successful Quitting	Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.	4 weeks	No
Secondary	Change in forgoing a cigarette	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 weeks	No
Secondary	Change in positive reinforcement attitudes	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).	4 weeks	No
Secondary	Change in negative reinforcement attitudes	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).	4 weeks	No
Secondary	Change in perceived likelihood	Perceived likelihood of developing smoking-related health outcomes will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.	4 weeks	No
Secondary	Change in frequency of conversations about warning labels	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.	4 weeks	No
Secondary	Fear	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).	4 weeks	No
Secondary	Cognitive elaboration	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).	4 weeks	No

External Links

•   Click here for more information about this study (North Carolina site):"Impact of Graphic Cigarette Warnings"