Cigarette Smoking BehaviorNCT02785484
Impact of Cigarette Pack Constituent Disclosures
A study testing Label with constituent disclosure message and Label with litter message in people with Cigarette Smoking Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Label with constituent disclosure message and Label with litter message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ewald & Wasserman Research Consultants, LLC
San Francisco, California, 94108
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Label with constituent disclosure message, Label with litter message
- Keywords
- Cigarette smoking, Smoking, Tobacco use
- Medical subject headings
- Cigarette Smoking, Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Label with constituent disclosure messageOther
Labels with constituent disclosure messages that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs 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.
Label with litter messageOther
Labels with litter messages that include text about littering cigarette butts will be applied to participants' cigarette packs 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 litter messages selected at random; at the week 3 visit, they will get one of the 2 remaining litter message selected at random, and at the week 4 visit they will get the remaining litter message. Study investigators developed the text and design of these labels.
| Study group | Role | What they receive |
|---|---|---|
| Label with constituent disclosure message | Experimental | Not described Receives: Other: Label with constituent disclosure message |
| Label with litter message | Other | Not described Receives: Other: Label with litter message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit intentions
The primary outcome is quit intentions measured at 4 weeks by survey.
Measured: 4 weeks
Secondary outcomes (9)
Awareness of health effects from smoking cigarettes
Awareness of health effects will be measured at 4 weeks by survey.
Measured: 4 weeks
Awareness of cigarette smoke constituents
Awareness of constituents will be measured at 4 weeks by survey.
Measured: 4 weeks
Quit attempts
Quit attempt will be measured during the 4 weeks of the study, reported at either 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.
Measured: Up to 4 weeks
Successful Quitting
Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.
Measured: 4 weeks
Forgoing a cigarette
Forgoing a cigarette will be measured at 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less.
Measured: 4 weeks
Perceived likelihood
Perceived likelihood of developing smoking-related health outcomes will be measured at 4 weeks by survey.
Measured: 4 weeks
Frequency of conversations about health messages
Frequency of conversations with others about the health message on cigarette packs will be measured at 4 weeks by survey.
Measured: 4 weeks
Negative affective reactions
Negative affect will be measured at 4 weeks by survey.
Measured: 4 weeks
Cognitive elaboration
Cognitive elaboration (how much the participant reports thinking about the label) will be measured at 4 weeks by survey.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Noel Brewer, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785484
- Sponsor's protocol ID
- 12-2430
- Other IDs
- P50CA180907
- Status last verified
- Jun 2017
- First submitted
- 4 Apr 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Brewer NT, Jeong M, Mendel JR, Hall MG, Zhang D, Parada H Jr, Boynton MH, Noar SM, Baig SA, Morgan JC, Ribisl KM. Cigarette pack messages about toxic chemicals: a randomised clinical trial. Tob Control. 2019 Jan;28(1):74-80. doi: 10.1136/tobaccocontrol-2017-054112. Epub 2018 Apr 13.
PubMed 29654122
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Impact of Cigarette Pack Constituent Disclosures
- ClinicalTrials.gov ID
- NCT02785484
- Acronym / sponsor ID
- 12-2430
- Conditions
- Cigarette Smoking Behavior
- Keywords
- Cigarette smoking, Smoking, Tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Label with constituent disclosure message | Experimental | Other: Label with constituent disclosure message |
| Label with litter message | Other | Other: Label with litter message |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Label with constituent disclosure messageLabels with constituent disclosure messages that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs 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. | Other | Label with constituent disclosure message |
| Label with litter messageLabels with litter messages that include text about littering cigarette butts will be applied to participants' cigarette packs 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 litter messages selected at random; at the week 3 visit, they will get one of the 2 remaining litter message selected at random, and at the week 4 visit they will get the remaining litter message. Study investigators developed the text and design of these labels. | Other | Label with litter message |
Primary outcome
Quit intentions
Time frame: 4 weeks
The primary outcome is quit intentions measured at 4 weeks by survey.
9 secondary outcomes
Awareness of health effects from smoking cigarettes
Time frame: 4 weeks
Awareness of cigarette smoke constituents
Time frame: 4 weeks
Quit attempts
Time frame: Up to 4 weeks
Successful Quitting
Time frame: 4 weeks
Forgoing a cigarette
Time frame: 4 weeks
Perceived likelihood
Time frame: 4 weeks
Frequency of conversations about health messages
Time frame: 4 weeks
Negative affective reactions
Time frame: 4 weeks
Cognitive elaboration
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 29654122Brewer NT, Jeong M, Mendel JR, Hall MG, Zhang D, Parada H Jr, Boynton MH, Noar SM, Baig SA, Morgan JC, Ribisl KM. Cigarette pack messages about toxic chemicals: a randomised clinical trial. Tob Control. 2019 Jan;28(1):74-80. doi: 10.1136/tobaccocontrol-2017-054112. Epub 2018 Apr 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel Brewer, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Label with constituent disclosure message and Label with litter message in people with Cigarette Smoking Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit intentions (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.