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Effect of Packaging on Smoking Perceptions and Behavior (CASA)

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ClinicalTrials.gov Identifier: NCT02676193
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
David Strong, University of California, San Diego

Brief 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. 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 plain 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.

Condition or disease Intervention/treatment Phase
Smoking Tobacco Smoking Behavioral: Effect of Packaging on Smoking Perceptions and Behavior Not Applicable

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 21-50, 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) plain pack design with all marketing materials removed (PP), b) plain pack with a large graphic warning label (AM: Australian model) and c) standard pack with marketing materials intact (ST: US model).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
Actual Study Start Date : February 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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: Plain Packs
The intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using plain packaging for three months. Plain 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.



Primary Outcome Measures :
  1. Changes in Perceptions of Tobacco Use Measured by Questionnaire Data [ Time Frame: Assessed at month 4 and month 12. ]
  2. Changes in Perceptions of Packs Measured by Questionnaire Data [ Time Frame: Assessed at month 4 and month 12 ]
  3. Changes in Tobacco Use Measured by Cigarette Purchase Data [ Time Frame: Assessed at month 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676193


Contacts
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Contact: David R Strong, PhD 858-822-6562 dstrong@ucsd.edu
Contact: John P Pierce, PhD 858-822-2380 jppierce@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: David Strong, PhD       dstrong@ucsd.edu   
Contact: Jesica Oratowski, MPH    858-822-3311    joratowski@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: David Strong, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02676193     History of Changes
Other Study ID Numbers: R01CA190347 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Keywords provided by David Strong, University of California, San Diego:
Tobacco Smoking
Cigarettes
Packaging
Text messaging
Graphic Images
Sensor-Based Assessments