Impact of Cigarette Pack Constituent Disclosures
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/28/2016 |
| Start Date: | August 2016 |
| End Date: | August 2017 |
| Contact: | Noel Brewer, PhD |
| Email: | ntb@unc.edu |
| Phone: | 919-966-3282 |
Randomized Controlled Trial Evaluating the Impact of Cigarette Pack Constituent Disclosures
The purpose of this randomized controlled trial is to determine whether constituent
disclosures on cigarette packs increase intentions to quit smoking. Previous studies have
been informative, but they have evaluated candidate graphic warnings, not constituent
disclosures. Furthermore, they typically expose participants to messages in controlled but
artificial experimental settings for a short period of time, using much lower frequency and
shorter duration of message exposure than found in the real world. This study addresses
these issues by evaluating the impact of constituent disclosures by randomly assigning
smokers to have their cigarette packs labeled with constituent disclosure messages or
cigarette butt littering messages.
disclosures on cigarette packs increase intentions to quit smoking. Previous studies have
been informative, but they have evaluated candidate graphic warnings, not constituent
disclosures. Furthermore, they typically expose participants to messages in controlled but
artificial experimental settings for a short period of time, using much lower frequency and
shorter duration of message exposure than found in the real world. This study addresses
these issues by evaluating the impact of constituent disclosures by randomly assigning
smokers to have their cigarette packs labeled with constituent disclosure messages or
cigarette butt littering messages.
Federal law requires the U.S. Food and Drug Administration (FDA) to disseminate information
about tobacco constituents. The 2009 Family Smoking Prevention and Tobacco Control Act
grants FDA broad authority to regulate tobacco products, including helping the public to
better understand harmful and potentially harmful constituents (HPHCs) present in tobacco
products and tobacco smoke. According to Section 206 of the Act, using the appropriate
federal rulemaking channels and procedures, FDA may require disclosure of tobacco
constituents if the disclosed information benefits public health and increases consumer
awareness of the health consequences of tobacco products. This study will assess the impact
of constituent disclosures on smokers' cigarette packs 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 5 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: At the week 2 visit, study personnel will randomly assign participants to one
of the two study arms. The investigators will determine the randomization order a priori.
Smokers have an equal chance of being randomized to have labels with constituent disclosure
messages or labels with litter messages applied to their cigarette packs.
Assessment: Participants will complete 5 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 all 5 visits, participants will complete a survey. At visits 2-4,
participants' will have their cigarette packs labeled based on their condition. Cigarette
packs will be tracked at all 5 study visits.
Detailed description of the intervention: Each week participants 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 and tracking. Additionally, they will bring in any
unused labeled packs from the previous visit when applicable. While participants are taking
the survey, research staff will count participants' cigarette packs. Study staff will mark
packs with a code indicating the date of the visit and label them.
Participants randomized to the intervention arm will have labels with constituent disclosure
messages applied to their cigarette packs during visits for weeks 2-4. Constituent
disclosures that include text about chemicals in cigarette smoke and health effects of the
chemicals will be applied to participants' cigarette packs as labels on the right side (the
Surgeon General's warning is on the left side). At the week 2 visit, participants' packs
will be labeled with 1 of 3 disclosures selected at random; at the week 3 visit, they will
get one of the 2 remaining disclosures selected at random, and at the week 4 visit they will
get the remaining disclosure. Study investigators developed the text and design of these
labels. Participants assigned to the control arm will have labels with litter messages
applied to the right side of their cigarette packs.
The investigators will instruct participants in both arms to smoke or not smoke as they
normally would. The investigators will assess how many cigarettes participants smoked from
packs previously brought to a visit and other sources to calculate intervention dose (% of
cigarettes smoked from labeled packs). At the end of the study, participants will receive a
list of cessation resources.
about tobacco constituents. The 2009 Family Smoking Prevention and Tobacco Control Act
grants FDA broad authority to regulate tobacco products, including helping the public to
better understand harmful and potentially harmful constituents (HPHCs) present in tobacco
products and tobacco smoke. According to Section 206 of the Act, using the appropriate
federal rulemaking channels and procedures, FDA may require disclosure of tobacco
constituents if the disclosed information benefits public health and increases consumer
awareness of the health consequences of tobacco products. This study will assess the impact
of constituent disclosures on smokers' cigarette packs 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 5 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: At the week 2 visit, study personnel will randomly assign participants to one
of the two study arms. The investigators will determine the randomization order a priori.
Smokers have an equal chance of being randomized to have labels with constituent disclosure
messages or labels with litter messages applied to their cigarette packs.
Assessment: Participants will complete 5 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 all 5 visits, participants will complete a survey. At visits 2-4,
participants' will have their cigarette packs labeled based on their condition. Cigarette
packs will be tracked at all 5 study visits.
Detailed description of the intervention: Each week participants 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 and tracking. Additionally, they will bring in any
unused labeled packs from the previous visit when applicable. While participants are taking
the survey, research staff will count participants' cigarette packs. Study staff will mark
packs with a code indicating the date of the visit and label them.
Participants randomized to the intervention arm will have labels with constituent disclosure
messages applied to their cigarette packs during visits for weeks 2-4. Constituent
disclosures that include text about chemicals in cigarette smoke and health effects of the
chemicals will be applied to participants' cigarette packs as labels on the right side (the
Surgeon General's warning is on the left side). At the week 2 visit, participants' packs
will be labeled with 1 of 3 disclosures selected at random; at the week 3 visit, they will
get one of the 2 remaining disclosures selected at random, and at the week 4 visit they will
get the remaining disclosure. Study investigators developed the text and design of these
labels. Participants assigned to the control arm will have labels with litter messages
applied to the right side of their cigarette packs.
The investigators will instruct participants in both arms to smoke or not smoke as they
normally would. The investigators will assess how many cigarettes participants smoked from
packs previously brought to a visit and other sources to calculate intervention dose (% of
cigarettes smoked from labeled packs). At the end of the study, participants will receive a
list of cessation resources.
Inclusion Criteria:
- Be 21 years or older
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes every day or some days
- Currently smoke at least 7 cigarettes per week, on average
- Be able to read and speak English
- Be able to use a computer to take surveys
- Be able to attend 5 weekly appointments
- Be able to bring in 8 days' worth of cigarettes to each of the first 4 weekly
appointments
Exclusion Criteria:
- Smokers who smoke exclusively roll-your-own cigarettes
- Pregnant women
- Smokers concurrently enrolled in any research studies about smoking or using other
tobacco products
- Smokers who live in the same household as someone who has enrolled in the study
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