Clinical trial NCT02676193: Effect of Packaging on Smoking Perceptions and Behavior
Official title: Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Smoking
Keywords: Tobacco Smoking
Cigarettes
Packaging
Text messaging
Graphic Images
Sensor-Based Assessments
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 359
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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 21-65, 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).

Eligibility 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

Primary outcomes:
measure: Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal
timeFrame: Assessed over 4-months and 12-months
measure: Changes in Awareness and Concern about Health Hazards
timeFrame: Assessed over 4-months and 12-months
measure: Changes in routinized behavior and persistence over time.
timeFrame: Assessed over 4-months and 12-months
measure: Changes in cigarette smoking behaviors.
timeFrame: Assessed over 4-months and 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Pierce JP, Kealey S, Leas EC, Pulvers K, Stone MD, Oratowski J, Brighton E, Villasenor A, Strong DR. Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214242. doi: 10.1001/jamanetworkopen.2022.14242.
citation: Strong DR, Pierce JP, Pulvers K, Stone MD, Villasenor A, Pu M, Dimofte CV, Leas EC, Oratowski J, Brighton E, Hurst S, Kealey S, Chen R, Messer K. Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121387. doi: 10.1001/jamanetworkopen.2021.21387.