Summary

for people ages 21-65 (full criteria)
at La Jolla, California
study started
estimated completion:
David Strong

Description

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.

Official Title

Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial

Details

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).

Keywords

Smoking Tobacco Smoking Cigarettes Packaging Text messaging Graphic Images Sensor-Based Assessments Effect of Packaging on Smoking Perceptions and Behavior Australian Packs Plain Packs American Packs

Eligibility

You can join if…

Open to people ages 21-65

  • 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

You CAN'T join if...

  • 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

Location

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

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02676193
Study Type
Interventional
Last Updated