Communicating Smoking Risks Through Graphic Warning Labels

Phase 3

Completed

• Conditions: Lung Cancer; Heart Disease
• Interventions: Behavioral: Control; Behavioral: Picture warning

• Registration Number: NCT01782053
• Lead Sponsor: University of Pennsylvania

Brief Summary

Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. This trial tests the effectiveness of the warnings proposed by the Food and Drug Administration by providing cigarettes with the proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In addition, the trial tests the effects of different warning label components.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• smoke between 5 and 40 cigarettes per day and 100 in lifetime
• Not currently trying to quit
• between 18 and 65 years of age

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Exclusion Criteria

• smokes 120's or roll-your own or noncommercial cigarettes
• pregnant or breastfeeding
• history of substance abuse past 5 years
• more than 25 standard alcohol drinks per week
• use of other nicotine products, such as cigars, nicotine gum
• current treatment for copd, cancer, pulmonary disease, alcohol/drug dependence
• current treatment for a psychiatric condition
• physical/visual/mental impairment that prevents reading from a computer screen
• not US resident
• unable to read English
• English not main language
• other member of household in study
• friend who smokes in study
• unable to attend weekly appointments between 9 am and 6 pm Monday-Friday
• unable to use hand-held computer to enter daily mood ratings

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control condition	Control	Current packaging with warning on side replaced with one of 9 mandated warning statements
Picture plus additional warning text	Picture warning	Same as text plus picture but containing additional text elaborating on the basis for the warning.
Text plus picture	Picture warning	Revised packaging with half of front and back of pack showing FDA proposed warning including image.

Primary Outcome Measures

Name	Time	Method
Intention to try to quit smoking in next 30 days	Assessed after 4 weeks of exposure to new labels

Secondary Outcome Measures

Name	Time	Method
Affective reactions toward cigarettes and smoking cues	After 4 weeks of exposure to the new warning labels

Trial Locations

Locations (2)

Annenberg Public Policy Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Lazenby Hall, Ohio State University; 🇺🇸 Columbus, Ohio, United States