Communicating Smoking Risks Through Graphic Warning Labels

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Dan Romer, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01782053
First received: January 29, 2013
Last updated: December 1, 2014
Last verified: December 2014

January 29, 2013
December 1, 2014
January 2013
April 2014   (final data collection date for primary outcome measure)
Intention to try to quit smoking in next 30 days [ Time Frame: Assessed after 4 weeks of exposure to new labels ] [ Designated as safety issue: No ]
Intention to try to quit smoking in next 30 days [ Time Frame: Assessed after 4 weeks of exposure to new labels ] [ Designated as safety issue: No ]
One of the primary aims of the warning labels is to encourage quitting among current smokers. The outcome will determine whether pictorial labels increase the intention to do so among current smokers.
Complete list of historical versions of study NCT01782053 on ClinicalTrials.gov Archive Site
Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ] [ Designated as safety issue: No ]
Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ] [ Designated as safety issue: No ]
Warnings are hypothesized to attach negative affect toward cigarettes and act of smoking. We will assess this outcome to determine whether smokers feel less positively about their habit as a function of type of warning.
Not Provided
Not Provided
 
Communicating Smoking Risks Through Graphic Warning Labels
Communicating Smoking Risks Through Graphic Warning Labels
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Lung Cancer
  • Heart Disease
  • Behavioral: Picture warning
    Warning contains picture proposed for each text statement by FDA
  • Behavioral: Control
  • Experimental: Control condition
    Current packaging with warning on side replaced with one of 9 mandated warning statements
    Intervention: Behavioral: Control
  • Experimental: Text plus picture
    Revised packaging with half of front and back of pack showing FDA proposed warning including image.
    Intervention: Behavioral: Picture warning
  • Experimental: Picture plus additional warning text
    Same as text plus picture but containing additional text elaborating on the basis for the warning.
    Intervention: Behavioral: Picture warning
Evans AT, Peters E, Strasser AA, Emery LF, Sheerin KM, Romer D. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial. PLoS One. 2015 Dec 16;10(12):e0142879. doi: 10.1371/journal.pone.0142879. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01782053
1R01CA157824-01A1
No
Not Provided
Not Provided
Dan Romer, University of Pennsylvania
University of Pennsylvania
Ohio State University
Principal Investigator: Daniel Romer, PhD University of Pennsylvania
Principal Investigator: Ellen Peters, PhD Ohio State University
University of Pennsylvania
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP