Communicating Smoking Risks Through Graphic Warning Labels

Phase 3CompletedNCT01782053

University of Pennsylvania245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

245

Conditions

Lung Cancer Heart Disease

Interventions

Picture warningBEHAVIORAL

Warning contains picture proposed for each text statement by FDA

ControlBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Lazenby Hall, Ohio State University

Columbus, Ohio, United States

Annenberg Public Policy Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Intention to try to quit smoking in next 30 days

Time frame: Assessed after 4 weeks of exposure to new labels

Secondary Outcomes

Affective reactions toward cigarettes and smoking cues

Time frame: After 4 weeks of exposure to the new warning labels

Data from ClinicalTrials.gov

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