SmokingCASANCT02676193
Effect of Packaging on Smoking Perceptions and Behavior
A study testing Effect of Packaging on Smoking Perceptions and Behavior in people with Smoking and Tobacco Smoking, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators are addressing two critical areas identified by the FDA: the impact of cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the effectiveness of graphic warning labels on communicating risk of tobacco products. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking, Tobacco Smoking
- What is being tested?
- Effect of Packaging on Smoking Perceptions and Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Sep 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-65 years of age
- A current resident of San Diego County
- Daily smokers of at least 5 cigarettes/day who are classified as in the pre-contemplator stage of change (i.e. do not intend to quit smoking in the next 6-months)
- Regular smokers of popular U.S. cigarette brands
- Have a cell phone with a text messaging service plan
Who cannot join
- Non-Daily cigarette smokers and daily smokers of alternative brand cigarettes
- Marked organic impairment or unstable medical problems (such as a seizure disorder)
- Current pregnancy or intent to become pregnant during the next 12 weeks
- Prisoners, incarcerated or institutionalized individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
The investigators are addressing two critical areas identified by the FDA: the impact of cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the effectiveness of graphic warning labels on communicating risk of tobacco products. In a randomized controlled trial (RCT), investigators will enroll committed smokers who have no intention of quitting in the next 6-months. The three study arms will be: a) a blank pack with all marketing materials removed (PP); b) The Australian graphic warning images (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The study includes a three month purchasing intervention and continued follow-up through 12 months. Throughout the study interactive text messaging assessments will be used to measure acute and persistent impact of labeling and marketing on perceptions of tobacco products, subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior, and quitting motivation. At three separate time points, participants will: a) complete a web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous design and extensive objective measurements are significant innovations on the currently published research in this field and should lead to significant advances in tobacco regulatory science.
Read the detailed description
Smokers handle their packs frequently. Product packaging is a crucial medium by which the tobacco industry communicates product attributes, including reassurances about risk. The industry uses branded imagery on packs to influence consumer perceptions of their product, while at the same time the tobacco control community uses health warning labels to communicate harmful and potentially harmful constituents and risks of tobacco products. The World Health Organization Framework Convention on Tobacco Control (WHO FCTC) is a treaty enacted to ensure that every person is informed of the health consequences and addictive nature of tobacco consumption. Article 11 of the treaty requires Parties to implement large, rotating health warnings and urges governments to restrict or prohibit the use of Industry logos, colors, brand images or promotional information on packaging other than brand names and product names displayed in a standard color and font style. Study Objective: To conduct a randomized trial of the effect of cigarette pack design on 450 smokers of popular cigarette brands aged 21-65, who are committed to continue smoking (no intention to quit in the next 6-months). These committed smokers will be randomized to have their cigarettes packaged in one of 3 study arms: a) blank pack design with all marketing materials removed (BP), b) blank pack with a large graphic warning label (AM: Australian model) and c) standard pack with marketing materials intact (ST: US model).
- Conditions
- Smoking, Tobacco Smoking
- Being tested
- Effect of Packaging on Smoking Perceptions and Behavior
- Keywords
- Tobacco Smoking, Cigarettes, Packaging, Text messaging, Graphic Images, Sensor-Based Assessments
- Medical subject headings
- Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Packaging on Smoking Perceptions and BehaviorBehavioural
The intervention is the use of the assigned pack design.
| Study group | Role | What they receive |
|---|---|---|
| Australian Packs | Experimental | The intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using standard Australian marketing for three months. Receives: Behavioral: Effect of Packaging on Smoking Perceptions and Behavior |
| Blank Packs | Experimental | The intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using blank packaging for three months. Blank packaging will indicate participants brand and will not have any brand-related images or labels. Receives: Behavioral: Effect of Packaging on Smoking Perceptions and Behavior |
| American Packs | No intervention | Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal
Changes in perceptions of risk from tobacco use and appeal of tobacco packs
Measured: Assessed over 4-months and 12-months
Changes in Awareness and Concern about Health Hazards
Changes in perceptions of harm and potential risks
Measured: Assessed over 4-months and 12-months
Changes in routinized behavior and persistence over time.
Decreased willingness to display the pack in public.
Measured: Assessed over 4-months and 12-months
Changes in cigarette smoking behaviors.
Changes in the percent smokers, consumption per smoker, and recent quit attempts validated with saliva cotinine.
Measured: Assessed over 4-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2022
- Study completionSep 2022
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 SmokingStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Strong, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676193
- Sponsor's protocol ID
- R01CA190347
- Acronym
- CASA
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2016
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierce JP, Kealey S, Leas EC, Pulvers K, Stone MD, Oratowski J, Brighton E, Villasenor A, Strong DR. Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214242. doi: 10.1001/jamanetworkopen.2022.14242.
PubMed 35653155Strong DR, Pierce JP, Pulvers K, Stone MD, Villasenor A, Pu M, Dimofte CV, Leas EC, Oratowski J, Brighton E, Hurst S, Kealey S, Chen R, Messer K. Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121387. doi: 10.1001/jamanetworkopen.2021.21387.
PubMed 34347057
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02676193
- Acronym / sponsor ID
- CASA / R01CA190347
- Conditions
- Smoking, Tobacco Smoking
- Keywords
- Tobacco Smoking, Cigarettes, Packaging, Text messaging, Graphic Images, Sensor-Based Assessments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 8 Feb 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 investigators are addressing two critical areas identified by the FDA: the impact of cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the effectiveness of graphic warning labels on communicating risk of tobacco products. In a randomized controlled trial (RCT), investigators will enroll committed smokers who have no intention of quitting in the next 6-months. The three study arms will be: a) a blank pack with all marketing materials removed (PP); b) The Australian graphic warning images (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The study includes a three month purchasing intervention and continued follow-up through 12 months. Throughout the study interactive text messaging assessments will be used to measure acute and persistent impact of labeling and marketing on perceptions of tobacco products, subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior, and quitting motivation. At three separate time points, participants will: a) complete a web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous design and extensive objective measurements are significant innovations on the currently published research in this field and should lead to significant advances in tobacco regulatory science.
Detailed description
Smokers handle their packs frequently. Product packaging is a crucial medium by which the tobacco industry communicates product attributes, including reassurances about risk. The industry uses branded imagery on packs to influence consumer perceptions of their product, while at the same time the tobacco control community uses health warning labels to communicate harmful and potentially harmful constituents and risks of tobacco products. The World Health Organization Framework Convention on Tobacco Control (WHO FCTC) is a treaty enacted to ensure that every person is informed of the health consequences and addictive nature of tobacco consumption. Article 11 of the treaty requires Parties to implement large, rotating health warnings and urges governments to restrict or prohibit the use of Industry logos, colors, brand images or promotional information on packaging other than brand names and product names displayed in a standard color and font style. Study Objective: To conduct a randomized trial of the effect of cigarette pack design on 450 smokers of popular cigarette brands aged 21-65, who are committed to continue smoking (no intention to quit in the next 6-months). These committed smokers will be randomized to have their cigarettes packaged in one of 3 study arms: a) blank pack design with all marketing materials removed (BP), b) blank pack with a large graphic warning label (AM: Australian model) and c) standard pack with marketing materials intact (ST: US model).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Australian Packs | Experimental | Behavioral: Effect of Packaging on Smoking Perceptions and BehaviorThe intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using standard Australian marketing for three months. |
| Blank Packs | Experimental | Behavioral: Effect of Packaging on Smoking Perceptions and BehaviorThe intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using blank packaging for three months. Blank packaging will indicate participants brand and will not have any brand-related images or labels. |
| American Packs | No intervention | –Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21-65 years of age
- A current resident of San Diego County
- Daily smokers of at least 5 cigarettes/day who are classified as in the pre-contemplator stage of change (i.e. do not intend to quit smoking in the next 6-months)
- Regular smokers of popular U.S. cigarette brands
- Have a cell phone with a text messaging service plan
Key exclusion criteria (4 listed)
- Non-Daily cigarette smokers and daily smokers of alternative brand cigarettes
- Marked organic impairment or unstable medical problems (such as a seizure disorder)
- Current pregnancy or intent to become pregnant during the next 12 weeks
- Prisoners, incarcerated or institutionalized individuals
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 |
|---|---|---|
| Effect of Packaging on Smoking Perceptions and BehaviorThe intervention is the use of the assigned pack design. | Behavioural | Australian Packs, Blank Packs |
Primary outcome
Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal
Time frame: Assessed over 4-months and 12-months
Changes in perceptions of risk from tobacco use and appeal of tobacco packs
Changes in Awareness and Concern about Health Hazards
Time frame: Assessed over 4-months and 12-months
Changes in perceptions of harm and potential risks
Changes in routinized behavior and persistence over time.
Time frame: Assessed over 4-months and 12-months
Decreased willingness to display the pack in public.
Changes in cigarette smoking behaviors.
Time frame: Assessed over 4-months and 12-months
Changes in the percent smokers, consumption per smoker, and recent quit attempts validated with saliva cotinine.
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 Jan 2025.
- Derived from this study: PubMed 35653155Pierce JP, Kealey S, Leas EC, Pulvers K, Stone MD, Oratowski J, Brighton E, Villasenor A, Strong DR. Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214242. doi: 10.1001/jamanetworkopen.2022.14242.
- Derived from this study: PubMed 34347057Strong DR, Pierce JP, Pulvers K, Stone MD, Villasenor A, Pu M, Dimofte CV, Leas EC, Oratowski J, Brighton E, Hurst S, Kealey S, Chen R, Messer K. Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121387. doi: 10.1001/jamanetworkopen.2021.21387.
Related trials for Smoking
RecruitingPhase 4
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Smoking (Tobacco) Addiction
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Packaging on Smoking Perceptions and Behavior in people with Smoking and Tobacco Smoking, run by University of California, San Diego 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 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 Jan 2025. 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?
Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal (time frame: Assessed over 4-months and 12-months). The study lists 4 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 NCT02676193, 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 8 Jan 2025.