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Communicating Smoking Risks Through Graphic Warning Labels

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782053
First Posted: February 1, 2013
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Dan Romer, University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Lung Cancer Heart Disease Behavioral: Picture warning Behavioral: Control Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Communicating Smoking Risks Through Graphic Warning Labels

Resource links provided by NLM:


Further study details as provided by Dan Romer, University of Pennsylvania:

Primary Outcome Measures:
  • Intention to try to quit smoking in next 30 days [ Time Frame: Assessed after 4 weeks of exposure to new labels ]

Secondary Outcome Measures:
  • Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ]

Enrollment: 245
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control condition
Current packaging with warning on side replaced with one of 9 mandated warning statements
Behavioral: Control
Experimental: Text plus picture
Revised packaging with half of front and back of pack showing FDA proposed warning including image.
Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA
Experimental: Picture plus additional warning text
Same as text plus picture but containing additional text elaborating on the basis for the warning.
Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782053


Locations
United States, Ohio
Lazenby Hall, Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Annenberg Public Policy Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Ohio State University
Investigators
Principal Investigator: Daniel Romer, PhD University of Pennsylvania
Principal Investigator: Ellen Peters, PhD Ohio State University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dan Romer, Director, Adolescent Communication Institute, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01782053     History of Changes
Other Study ID Numbers: 1R01CA157824-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 29, 2013
First Posted: February 1, 2013
Last Update Posted: December 2, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases