Communicating Smoking Risks Through Graphic Warning Labels

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Pennsylvania
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: April 8, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control condition Behavioral: Control
Experimental: Text plus picture Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA
Experimental: Picture plus quitline number Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA
Experimental: Picture plus additional warning text Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA
Experimental: Picture + quitline plus additional text Behavioral: Picture warning
Warning contains picture proposed for each text statement by FDA

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782053

Locations
United States, Ohio
Lazenby Hall, Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael Fardel, BA    614-292-0788    osucigarettestudy@osu.edu   
Principal Investigator: Ellen Peters, PhD         
United States, Pennsylvania
Annenberg Public Policy Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lydia Emery, BA    215-746-0278    lemery@asc.upenn.edu   
Principal Investigator: Dan Romer, PhD         
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

No publications provided

Responsible Party: Dan Romer, Director, Adolescent Communication Institute, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01782053     History of Changes
Other Study ID Numbers: 1R01CA157824-01A1
Study First Received: January 29, 2013
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Lung Neoplasms
Cardiovascular Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014