Smoking Clinical Trial
— CASAOfficial title:
Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial
Verified date | March 2022 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 359 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal | Changes in perceptions of risk from tobacco use and appeal of tobacco packs | Assessed over 4-months and 12-months | |
Primary | Changes in Awareness and Concern about Health Hazards | Changes in perceptions of harm and potential risks | Assessed over 4-months and 12-months | |
Primary | Changes in routinized behavior and persistence over time. | Decreased willingness to display the pack in public. | Assessed over 4-months and 12-months | |
Primary | Changes in cigarette smoking behaviors. | Changes in the percent smokers, consumption per smoker, and recent quit attempts validated with saliva cotinine. | Assessed over 4-months and 12-months |
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