Communicating Smoking Risks Through Graphic Warning Labels

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University of Pennsylvania

Status and phase

Completed
Phase 3

Conditions

Lung Cancer
Heart Disease

Treatments

Behavioral: Picture warning
Behavioral: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT01782053
1R01CA157824-01A1

Details and patient eligibility

About

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.

Enrollment

245 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

245 participants in 3 patient groups

Control condition
Experimental group
Description:
Current packaging with warning on side replaced with one of 9 mandated warning statements
Treatment:
Behavioral: Control
Text plus picture
Experimental group
Description:
Revised packaging with half of front and back of pack showing FDA proposed warning including image.
Treatment:
Behavioral: Picture warning
Picture plus additional warning text
Experimental group
Description:
Same as text plus picture but containing additional text elaborating on the basis for the warning.
Treatment:
Behavioral: Picture warning

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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