Communicating Smoking Risks Through Graphic Warning Labels

Lung Cancer Clinical Trial

Official title:

Communicating Smoking Risks Through Graphic Warning Labels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782053
• Other study ID #: 1R01CA157824-01A1
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2013
• Last updated: December 1, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Disease
• Lung Cancer

Intervention

Behavioral:
• Picture warning
Warning contains picture proposed for each text statement by FDA
• Control

Locations

Country	Name	City	State
United States	Lazenby Hall, Ohio State University	Columbus	Ohio
United States	Annenberg Public Policy Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to try to quit smoking in next 30 days		Assessed after 4 weeks of exposure to new labels	No
Secondary	Affective reactions toward cigarettes and smoking cues		After 4 weeks of exposure to the new warning labels	No