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Does Real World Exposure to FDA Graphic Warnings Affect Tobacco Use Behavior?

Principal Investigator: Frank McCormick

Funding Mechanism: Intra-Departmental Delegation of Authority

ID Number: 3P30CA082103-15S2

Award Date: 4/25/2014

Institution: University of California-San Francisco 

To date, experimental research on the effectiveness of FDA graphic warning labels on cigarette packages has involved one-time exposure to the labels, an exposure duration that is too brief to generate accurate measurements of changes in tobacco use behavior. The goal of this research is to develop and test an experimental approach that simulates real-world prolonged exposure to graphic warning labels. Researchers will recruit 450 smokers aged 18 and older from three residential addiction treatment programs. After a baseline interview, researchers will affix one of nine experimental graphic warning labels (or a transparent label as a control condition) to patients’ own cigarette packs; after a 30-day exposure period, researchers will conduct follow-up interviews to identify any changes in smoking-related behaviors. Specific aims are: (1) to expose smokers to graphic warning labels repeatedly over time in the course of their usual tobacco use; and (2) to measure the impact of prolonged exposure to graphic warning labels on behavioral (i.e., intent to quit, quit attempts, cigarettes per day, initiation of cessation services) and communication-related (i.e., tobacco risk perception, impacts of cigarette pack warnings, thoughts about abstinence) outcomes. Research findings will provide information about the impact of real-world extended exposure to graphic warning labels on tobacco use-related factors and may inform FDA regulatory activities.

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