Effect of Packaging on Smoking Perceptions and Behavior
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 10/12/2018 |
| Start Date: | February 2016 |
| End Date: | March 2020 |
| Contact: | David R Strong, PhD |
| Email: | dstrong@ucsd.edu |
| Phone: | 858-822-6562 |
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 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.
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.
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).
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).
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
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