An interventional study of Effect of Packaging on Smoking Perceptions and Behavior in Smoking and Tobacco Smoking, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Other
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.
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).
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 359 is above the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.
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Exclusion Criteria:
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 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
Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months.
The intervention is the use of the assigned pack design.
Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal
Changes in perceptions of risk from tobacco use and appeal of tobacco packs
Time frame: Assessed over 4-months and 12-months
Changes in Awareness and Concern about Health Hazards
Changes in perceptions of harm and potential risks
Time frame: Assessed over 4-months and 12-months
Changes in routinized behavior and persistence over time.
Decreased willingness to display the pack in public.
Time frame: Assessed over 4-months and 12-months
Changes in cigarette smoking behaviors.
Changes in the percent smokers, consumption per smoker, and recent quit attempts validated with saliva cotinine.
Time frame: Assessed over 4-months and 12-months
Ran from Feb 2016 to primary completion in Sep 2022, 79 months.
Of 141 non-industry interventional studies with no phase under Smoking, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 79 months is above that.
Counting every sponsor, half of 155 studies reached it within 37 months; a quarter within 18 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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