Communicating Smoking Risks Through Graphic Warning Labels
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 245
- Locations
- 2
- Primary Endpoint
- Intention to try to quit smoking in next 30 days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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
Arms & Interventions
Control condition
Current packaging with warning on side replaced with one of 9 mandated warning statements
Intervention: Control (Behavioral)
Text plus picture
Revised packaging with half of front and back of pack showing FDA proposed warning including image.
Intervention: Picture warning (Behavioral)
Picture plus additional warning text
Same as text plus picture but containing additional text elaborating on the basis for the warning.
Intervention: Picture warning (Behavioral)
Outcomes
Primary Outcomes
Intention to try to quit smoking in next 30 days
Time Frame: Assessed after 4 weeks of exposure to new labels
Secondary Outcomes
- Affective reactions toward cigarettes and smoking cues(After 4 weeks of exposure to the new warning labels)
Investigators
Dan Romer
Director, Adolescent Communication Institute
University of Pennsylvania