Effect of Packaging on Smoking Perceptions and Behavior (CASA)

January 6, 2025 updated by: David Strong, University of California, San Diego

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Australian Packs
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.
Behavioral: Effect of Packaging on Smoking Perceptions and Behavior
The intervention is the use of the assigned pack design.
Experimental: Blank Packs
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.
Behavioral: Effect of Packaging on Smoking Perceptions and Behavior
The intervention is the use of the assigned pack design.
No Intervention: American Packs
Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Assessed over 4-months and 12-months
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
Assessed over 4-months and 12-months
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.
Assessed over 4-months and 12-months
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.
Assessed over 4-months and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01CA190347 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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