Tobacco UseNCT03446170
Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers
A study testing Graphic cigarette warning labels, plain packaging in people with Tobacco Use, run by Georgetown University at 1 site in United States.
Trial summary
The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Graphic cigarette warning labels, plain packaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 31 Aug 2020
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 to 30 years
- Smoke at least 100 cigarettes in their lifetime
- Now smoke cigarettes on all or some days
- Reside in the Washington, DC metro area
- Willing to send and receive text messages on a personal mobile phone
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers
The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.
Read the detailed description
The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.
- Conditions
- Tobacco Use
- Being tested
- Graphic cigarette warning labels, plain packaging
- Keywords
- Young adults, Cigarette smoking, Warning labels
- Medical subject headings
- Tobacco Use, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphic cigarette warning labels, plain packagingBehavioural
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
| Study group | Role | What they receive |
|---|---|---|
| Loss-framed, branded | Experimental | Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on branded packages. Receives: Behavioral: Graphic cigarette warning labels, plain packaging |
| Loss-framed, plain | Experimental | Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on plain or standardized packages. Receives: Behavioral: Graphic cigarette warning labels, plain packaging |
| Gain-framed, branded | Experimental | Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on branded packages. Receives: Behavioral: Graphic cigarette warning labels, plain packaging |
| Gain-framed, plain | Experimental | Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on plain or standardized packages. Receives: Behavioral: Graphic cigarette warning labels, plain packaging |
| Control | No intervention | Participants assigned to this arm use their regular cigarette packs and complete study measures only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette purchase appeal
The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?
Measured: Baseline
Motivation to quit smoking
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
Measured: At the conclusion of the 4 week exposure
Secondary outcomes (3)
Cigarette smoking behavior
Cigarettes smoked per day is measured using a single valid question assessing about how many cigarettes participants smoked each day, on average.
Measured: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Smoking quit attempts
Attempts to quit smoking is measured using a single valid item asking participants how many times they stopped smoking for 1 day or longer because they were trying to quit.
Measured: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Motivation to quit cigarette smoking.
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
Measured: At 1-month and 3-months post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Sep 2014
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Factorial
- Model description
- The experimental design is a 2 (graphic warning message framing: gain versus loss) by 2 (cigarette packaging: standardized, plain or branded) factorial design. An unexposed control group is also included.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Mays, Georgetown University
- Investigators
- Darren Mays, PhD, MPH, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446170
- Sponsor's protocol ID
- 2014-1031
- Status last verified
- Dec 2021
- First submitted
- 12 Feb 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will consider requests to share de-identified individual participant data by request and according to our study protocol and institutional data sharing policy.
Publications
Johnson AC, Luta G, Tercyak KP, Niaura RS, Mays D. Effects of pictorial warning label message framing and standardized packaging on cigarette packaging appeal among young adult smokers. Addict Behav. 2021 Sep;120:106951. doi: 10.1016/j.addbeh.2021.106951. Epub 2021 Apr 13.
PubMed 33895661Johnson AC, Turner MM, Simmens SJ, Evans WD, Strasser AA, Mays D. Mediational Effects on Motivation to Quit Smoking After Exposure to a Cigarette Pictorial Warning Label Among Young Adults. Ann Behav Med. 2022 Jul 12;56(7):737-748. doi: 10.1093/abm/kaab073.
PubMed 34415010Johnson AC, Simmens SJ, Turner MM, Evans WD, Strasser AA, Mays D. Longitudinal effects of cigarette pictorial warning labels among young adults. J Behav Med. 2022 Feb;45(1):124-132. doi: 10.1007/s10865-021-00258-2. Epub 2021 Sep 23.
PubMed 34554369
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers
- ClinicalTrials.gov ID
- NCT03446170
- Acronym / sponsor ID
- 2014-1031
- Conditions
- Tobacco Use
- Keywords
- Young adults, Cigarette smoking, Warning labels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- 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 objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.
Detailed description
The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The experimental design is a 2 (graphic warning message framing: gain versus loss) by 2 (cigarette packaging: standardized, plain or branded) factorial design. An unexposed control group is also included.
| Arm | Type | Receives |
|---|---|---|
| Loss-framed, branded | Experimental | Behavioral: Graphic cigarette warning labels, plain packagingParticipants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on branded packages. |
| Loss-framed, plain | Experimental | Behavioral: Graphic cigarette warning labels, plain packagingParticipants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on plain or standardized packages. |
| Gain-framed, branded | Experimental | Behavioral: Graphic cigarette warning labels, plain packagingParticipants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on branded packages. |
| Gain-framed, plain | Experimental | Behavioral: Graphic cigarette warning labels, plain packagingParticipants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on plain or standardized packages. |
| Control | No intervention | –Participants assigned to this arm use their regular cigarette packs and complete study measures only. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18 to 30 years
- Smoke at least 100 cigarettes in their lifetime
- Now smoke cigarettes on all or some days
- Reside in the Washington, DC metro area
- Willing to send and receive text messages on a personal mobile phone
Key exclusion criteria (1 listed)
- No additional exclusion criteria
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 cigarette warning labels, plain packagingThis study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging | Behavioural | Gain-framed, branded, Gain-framed, plain, Loss-framed, branded, Loss-framed, plain |
Primary outcome
Cigarette purchase appeal
Time frame: Baseline
The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?
Motivation to quit smoking
Time frame: At the conclusion of the 4 week exposure
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
3 secondary outcomes
Cigarette smoking behavior
Time frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Smoking quit attempts
Time frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Motivation to quit cigarette smoking.
Time frame: At 1-month and 3-months post-exposure
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 4 Jan 2022.
- Background: PubMed 33895661Johnson AC, Luta G, Tercyak KP, Niaura RS, Mays D. Effects of pictorial warning label message framing and standardized packaging on cigarette packaging appeal among young adult smokers. Addict Behav. 2021 Sep;120:106951. doi: 10.1016/j.addbeh.2021.106951. Epub 2021 Apr 13.
- Background: PubMed 34415010Johnson AC, Turner MM, Simmens SJ, Evans WD, Strasser AA, Mays D. Mediational Effects on Motivation to Quit Smoking After Exposure to a Cigarette Pictorial Warning Label Among Young Adults. Ann Behav Med. 2022 Jul 12;56(7):737-748. doi: 10.1093/abm/kaab073.
- Background: PubMed 34554369Johnson AC, Simmens SJ, Turner MM, Evans WD, Strasser AA, Mays D. Longitudinal effects of cigarette pictorial warning labels among young adults. J Behav Med. 2022 Feb;45(1):124-132. doi: 10.1007/s10865-021-00258-2. Epub 2021 Sep 23.
- Individual participant dataSharing planned: Undecided. We will consider requests to share de-identified individual participant data by request and according to our study protocol and institutional data sharing policy.
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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.
Darren Mays, PhD, MPH principal investigator
Georgetown University
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 cigarette warning labels, plain packaging in people with Tobacco Use, run by Georgetown University 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 5 inclusion and 1 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 4 Jan 2022. 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?
Cigarette purchase appeal (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03446170, which also lists 3 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 4 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.