Communicating Smoking Risks Through Graphic Warning Labels

Study Overview
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Brief Summary
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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.

Official Title
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Communicating Smoking Risks Through Graphic Warning Labels

Conditions
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Lung Cancer, Heart Disease

Intervention / Treatment
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* Behavioral: Picture warning
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control condition<br>Current packaging with warning on side replaced with one of 9 mandated warning statements | Behavioral: Control<br> <br> |
| Experimental: Text plus picture<br>Revised packaging with half of front and back of pack showing FDA proposed warning including image. | Behavioral: Picture warning<br>* Warning contains picture proposed for each text statement by FDA<br>|
| Experimental: Picture plus additional warning text<br>Same as text plus picture but containing additional text elaborating on the basis for the warning. | Behavioral: Picture warning<br>* Warning contains picture proposed for each text statement by FDA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to try to quit smoking in next 30 days |  | Assessed after 4 weeks of exposure to new labels | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affective reactions toward cigarettes and smoking cues |  | After 4 weeks of exposure to the new warning labels |