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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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 8, 2016
Last Update Posted Date October 10, 2018
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Changes in Perceptions of Tobacco Use Measured by Questionnaire Data [ Time Frame: Assessed at month 4 and month 12. ]
  • Changes in Perceptions of Packs Measured by Questionnaire Data [ Time Frame: Assessed at month 4 and month 12 ]
  • Changes in Tobacco Use Measured by Cigarette Purchase Data [ Time Frame: Assessed at month 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02676193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Packaging on Smoking Perceptions and Behavior
Official Title  ICMJE Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Smoking
  • Tobacco Smoking
Intervention  ICMJE Behavioral: Effect of Packaging on Smoking Perceptions and Behavior
The intervention is the use of the assigned pack design.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Effect of Packaging on Smoking Perceptions and Behavior
  • 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.
    Intervention: Behavioral: Effect of Packaging on Smoking Perceptions and Behavior
  • No Intervention: American Packs
    Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David R Strong, PhD 858-822-6562 dstrong@ucsd.edu
Contact: John P Pierce, PhD 858-822-2380 jppierce@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02676193
Other Study ID Numbers  ICMJE R01CA190347( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Strong, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP