Impact of Graphic Cigarette Warnings
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | September 2016 |
A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
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.
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.
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.
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
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2
sites
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Oakland, California 94612
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