Communicating Smoking Risks Through Graphic Warning Labels
This study is currently recruiting participants.
Verified April 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Dan Romer, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01782053
First received: January 29, 2013
Last updated: April 8, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 29, 2013 | ||||||||
| Last Updated Date | April 8, 2013 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Intention to try to quit smoking in next 30 days [ Time Frame: Assessed after 4 weeks of exposure to new labels ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Intention to try to quit smoking in next 30 days [ Time Frame: Assessed after 4 weeks of exposure to new labels ] [ Designated as safety issue: No ] One of the primary aims of the warning labels is to encourage quitting among current smokers. The outcome will determine whether pictorial labels increase the intention to do so among current smokers. |
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| Change History | Complete list of historical versions of study NCT01782053 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Affective reactions toward cigarettes and smoking cues [ Time Frame: After 4 weeks of exposure to the new warning labels ] [ Designated as safety issue: No ] Warnings are hypothesized to attach negative affect toward cigarettes and act of smoking. We will assess this outcome to determine whether smokers feel less positively about their habit as a function of type of warning. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Communicating Smoking Risks Through Graphic Warning Labels | ||||||||
| Official Title ICMJE | Communicating Smoking Risks Through Graphic Warning Labels | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 320 | ||||||||
| Estimated Completion Date | February 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01782053 | ||||||||
| Other Study ID Numbers ICMJE | 1R01CA157824-01A1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dan Romer, University of Pennsylvania | ||||||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||||||
| Collaborators ICMJE | Ohio State University | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pennsylvania | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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