Cigarette Smoking BehaviorNCT02301351
Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
A study testing Graphic Warning Label and Text Warning Label in people with Cigarette Smoking Behavior, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of changes in cigarette package color and warning label features on smoking behaviors and beliefs about cigarette risks. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Graphic Warning Label and Text Warning Label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 12 Apr 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months.
- Smokers of primarily non-menthol, Marlboro red or gold type cigarettes.
- Not using any forms of nicotine other than cigarettes.
- Not currently undergoing smoking cessation treatment or tying to quit.
- Able to communicate fluently in English (speaking, writing, and reading).
- Plan to remain in the area over the duration of the trial.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Who cannot join
- Smoking Behavior.
- Use of any nicotine products other than cigarettes.
- Enrollment or plans to enroll in a smoking cessation program over the duration of the trial.
- Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Day 0.
- Alcohol/Drugs.
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
Show all 19Show fewer
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Provide a breath alcohol concentration (BrAC) reading greater than .000 at Day 0.
- Medical.
- Women who are pregnant, planning a pregnancy, and/or lactating.
- Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
- Color blindness.
- Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
- Psychiatric.
- Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
- Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible.
- Other.
- Any medical condition, extenuating circumstance, illness, disorder, adverse event (AE), and/or concomitant medication that could compromise participant safety and/or completion of the study procedures, as determined by the Principal Investigator. Subjects may be deemed ineligible or withdrawn for any of the aforementioned reasons at any point throughout the study.
- Non-compliance with the protocol and/or study design as determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to examine the effect of changes in cigarette package color and warning label features on smoking behaviors and beliefs about cigarette risks.
Read the detailed description
This project will recruit 360, current daily Marlboro, non-menthol, red (n=180) or gold (n=180) cigarette smokers to a 50-day protocol using a randomized factorial design with two factors: (1) cigarette pack color manipulation (within subject: red, gold, plain packaging) and (2) warning label manipulation (between subject: graphic vs. standard text). The randomization will be stratified by own brand cigarette. To evaluate effects of changes in cigarette package coloring, participants will smoke commercially available cigarettes that may or may not be similar to their preferred brand of cigarettes throughout the study, but in different colored packages during three 15-day study periods (i.e., one period will be Marlboro plain (tan-olive) packs, one will be Marlboro gold packs and one will be Marlboro red packs; order counterbalanced). Participants will visit the Center every 5 days to complete assessments (11 total sessions).
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Graphic Warning Label, Text Warning Label
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphic Warning LabelOther
All packs provided will include FDA-approved graphic warning labels
Text Warning LabelOther
All packs provided will include standard text warning labels
| Study group | Role | What they receive |
|---|---|---|
| Graphic Warning Label | Other | Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with FDA-approved graphic warning labels. Receives: Other: Graphic Warning Label |
| Text Warning Label | Other | Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with standard text warning labels. Receives: Other: Text Warning Label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Cigarette Rate (smoking behavior)
Daily cigarette consumption will be determined by the difference of unused cigarettes and used cigarette filters returned to the Center every Session after Day 0.The number of used cigarette filters and self-reported daily smoking rate will be recorded on a Smoking Rate Data Collection Form. We will examine changes in daily cigarette consumption averaged over each of the three 15-day pack periods.
Measured: Days 0-50
Secondary outcomes (5)
Smoking Topography
All lab cigarettes will be smoked using a smoking topography machine. This device is specifically designed to collect smoking topography variables. A cigarette is placed in a sterilized mouthpiece, and the internal pressure transducer measures pressure changes that occur during inhalation. The pressure changes are amplified, digitized and sampled at 1000 Hz, then software converts the signal to airflow (ml/s) in real time (s), and from this provides number of puffs, puff volume, puff duration, maximum flow, and interpuff interval (time between puffs). The primary topography outcome is total puff volume, due to its well- characterized responsiveness to changes in cigarette type. However, the smoking topography device collects additional measures that will be considered for exploratory analyses. The primary analyses to test study hypotheses will use average puff volume across clinic days within each period.
Measured: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Subjective Cigarette Ratings
We will use our previous visual analog scale (VAS) to examine changes in subjective ratings using a 100 mm scale that has been used in previous smoking studies, including those used by the tobacco industry. Items include: strength, heat, draw, smoke smell, and burn rate. Composite ratings will be calculated in identical fashion to those described for the smoking topography outcome measures. Subjective cigarette ratings will be assessed after each cigarette smoked in the laboratory across all sessions.
Measured: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Carbon Monoxide (CO)
CO measures will be assessed at the onset of each session, and then before and after each cigarette smoked in the lab. The device has a digital screen which reports CO in parts per million (ppm). Participants will provide a CO breath sample using standard procedures; the largest steady reading will be recorded as the recorded CO level.
Measured: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Attitudes and Intentions (to use product)
We will assess participants' attitudes and intentions toward the cigarette packs and their using the 'new' cigarette, similar to our previous work on cigarette smoking that applied the Reasoned Action Approach. We will use Likert-type semantic differential scales (likely to use/not use, using product is enjoyable/non enjoyable, harmful/not harmful). Because the study is designed to assess changes in smoking behavior and beliefs, the Theory of Reasoned Action would postulate that changes in product use would be mediated by changes in attitudes, and then intentions.
Measured: Days 0, 5, 20, 35, & 50
Cigarette Risk Beliefs
To assess risk beliefs about participants' own brand of cigarettes on Day 0, we will use an 18-item, 5-point scale (1 = definitely not true; 5 = definitely true) including previously validated items assessing smokers' beliefs on cigarette harm. During applicable sessions post Day 0, participants will complete an 8-item, 5-point scale based on their assigned cigarettes. The Cigarette Risk Beliefs questionnaire will be administered on Day 0 before lab cigarette 1 (18-item baseline version), Day 5 before lab cigarette 1 and 2, Day 20 before lab cigarette 1 and 2, Day 35 before lab cigarette 1 and 2, and Day 50 before lab cigarette 1. The Cigarette Risk Beliefs questionnaire will be completed as the participant physically views a pack of their cigarette pack assignment (or own brand on Day 0) as per the randomization schema.
Measured: Days 0, 5, 20, 35, & 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrew Strasser, University of Pennsylvania
- Investigators
- Andrew Strasser, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301351
- Sponsor's protocol ID
- 819610
- Other IDs
- P50CA179546
- Status last verified
- Apr 2019
- First submitted
- 21 Nov 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: de-identified data and measures codebook will be made available after the conclusion of the study.
Publications
Stone MD, Mercincavage M, Wileyto EP, Tan ASL, Audrain-McGovern J, Villanti AC, Strasser AA. Effects of cigarette package colors and warning labels on marlboro smokers' risk beliefs, product appraisals, and smoking behavior: a randomized trial. BMC Public Health. 2023 Oct 27;23(1):2111. doi: 10.1186/s12889-023-17024-5.
PubMed 37891513Mercincavage M, Albelda B, Mays D, Souprountchouk V, Giovenco DP, Audrain-McGovern J, Strasser AA. Shedding 'light' on cigarette pack design: colour differences in product perceptions, use and exposure following the US descriptor ban. Tob Control. 2022 Jan;31(1):19-24. doi: 10.1136/tobaccocontrol-2020-055886. Epub 2020 Sep 29.
PubMed 32994296
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
- ClinicalTrials.gov ID
- NCT02301351
- Acronym / sponsor ID
- 819610
- Conditions
- Cigarette Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 25 Nov 2014 (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 study is to examine the effect of changes in cigarette package color and warning label features on smoking behaviors and beliefs about cigarette risks.
Detailed description
This project will recruit 360, current daily Marlboro, non-menthol, red (n=180) or gold (n=180) cigarette smokers to a 50-day protocol using a randomized factorial design with two factors: (1) cigarette pack color manipulation (within subject: red, gold, plain packaging) and (2) warning label manipulation (between subject: graphic vs. standard text). The randomization will be stratified by own brand cigarette. To evaluate effects of changes in cigarette package coloring, participants will smoke commercially available cigarettes that may or may not be similar to their preferred brand of cigarettes throughout the study, but in different colored packages during three 15-day study periods (i.e., one period will be Marlboro plain (tan-olive) packs, one will be Marlboro gold packs and one will be Marlboro red packs; order counterbalanced). Participants will visit the Center every 5 days to complete assessments (11 total sessions).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graphic Warning Label | Other | Other: Graphic Warning LabelDays 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with FDA-approved graphic warning labels. |
| Text Warning Label | Other | Other: Text Warning LabelDays 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with standard text warning labels. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months.
- Smokers of primarily non-menthol, Marlboro red or gold type cigarettes.
- Not using any forms of nicotine other than cigarettes.
- Not currently undergoing smoking cessation treatment or tying to quit.
- Able to communicate fluently in English (speaking, writing, and reading).
Key exclusion criteria (19 listed)
- Smoking Behavior.
- Use of any nicotine products other than cigarettes.
- Enrollment or plans to enroll in a smoking cessation program over the duration of the trial.
- Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Day 0.
- Alcohol/Drugs.
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 |
|---|---|---|
| Graphic Warning LabelAll packs provided will include FDA-approved graphic warning labels | Other | Graphic Warning Label |
| Text Warning LabelAll packs provided will include standard text warning labels | Other | Text Warning Label |
Primary outcome
Daily Cigarette Rate (smoking behavior)
Time frame: Days 0-50
Daily cigarette consumption will be determined by the difference of unused cigarettes and used cigarette filters returned to the Center every Session after Day 0.The number of used cigarette filters and self-reported daily smoking rate will be recorded on a Smoking Rate Data Collection Form. We will examine changes in daily cigarette consumption averaged over each of the three 15-day pack periods.
5 secondary outcomes
Smoking Topography
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Subjective Cigarette Ratings
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Carbon Monoxide (CO)
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50
Attitudes and Intentions (to use product)
Time frame: Days 0, 5, 20, 35, & 50
Cigarette Risk Beliefs
Time frame: Days 0, 5, 20, 35, & 50
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 16 Apr 2019.
- Derived from this study: PubMed 37891513Stone MD, Mercincavage M, Wileyto EP, Tan ASL, Audrain-McGovern J, Villanti AC, Strasser AA. Effects of cigarette package colors and warning labels on marlboro smokers' risk beliefs, product appraisals, and smoking behavior: a randomized trial. BMC Public Health. 2023 Oct 27;23(1):2111. doi: 10.1186/s12889-023-17024-5.
- Derived from this study: PubMed 32994296Mercincavage M, Albelda B, Mays D, Souprountchouk V, Giovenco DP, Audrain-McGovern J, Strasser AA. Shedding 'light' on cigarette pack design: colour differences in product perceptions, use and exposure following the US descriptor ban. Tob Control. 2022 Jan;31(1):19-24. doi: 10.1136/tobaccocontrol-2020-055886. Epub 2020 Sep 29.
- Individual participant dataSharing planned: Yes. de-identified data and measures codebook will be made available after the conclusion of the study.
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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.
Andrew Strasser, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graphic Warning Label and Text Warning Label in people with Cigarette Smoking Behavior, run by University of Pennsylvania 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 7 inclusion and 19 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 16 Apr 2019. 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?
Daily Cigarette Rate (smoking behavior) (time frame: Days 0-50). 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 NCT02301351, which also lists 2 linked publications.
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 16 Apr 2019.