Communicating Smoking Risks Through Graphic Warning Labels

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)

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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