- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782053
Communicating Smoking Risks Through Graphic Warning Labels
December 1, 2014 updated by: Dan Romer, University of Pennsylvania
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
245
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Lazenby Hall, Ohio State University
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Annenberg Public Policy Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control condition
Current packaging with warning on side replaced with one of 9 mandated warning statements
|
|
Experimental: Text plus picture
Revised packaging with half of front and back of pack showing FDA proposed warning including image.
|
Warning contains picture proposed for each text statement by FDA
|
Experimental: Picture plus additional warning text
Same as text plus picture but containing additional text elaborating on the basis for the warning.
|
Warning contains picture proposed for each text statement by FDA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intention to try to quit smoking in next 30 days
Time Frame: Assessed after 4 weeks of exposure to new labels
|
Assessed after 4 weeks of exposure to new labels
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Affective reactions toward cigarettes and smoking cues
Time Frame: After 4 weeks of exposure to the new warning labels
|
After 4 weeks of exposure to the new warning labels
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Romer, PhD, University of Pennsylvania
- Principal Investigator: Ellen Peters, PhD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 29, 2013
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CA157824-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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