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Communicating Smoking Risks Through Graphic Warning Labels

NCT ID: NCT01782053

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

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.

Detailed Description

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Conditions

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Lung Cancer Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control condition

Current packaging with warning on side replaced with one of 9 mandated warning statements

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Text plus picture

Revised packaging with half of front and back of pack showing FDA proposed warning including image.

Group Type EXPERIMENTAL

Picture warning

Intervention Type BEHAVIORAL

Warning contains picture proposed for each text statement by FDA

Picture plus additional warning text

Same as text plus picture but containing additional text elaborating on the basis for the warning.

Group Type EXPERIMENTAL

Picture warning

Intervention Type BEHAVIORAL

Warning contains picture proposed for each text statement by FDA

Interventions

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Picture warning

Warning contains picture proposed for each text statement by FDA

Intervention Type BEHAVIORAL

Control

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Dan Romer

Director, Adolescent Communication Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Romer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Ellen Peters, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Lazenby Hall, Ohio State University

Columbus, Ohio, United States

Site Status

Annenberg Public Policy Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Evans AT, Peters E, Strasser AA, Emery LF, Sheerin KM, Romer D. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial. PLoS One. 2015 Dec 16;10(12):e0142879. doi: 10.1371/journal.pone.0142879. eCollection 2015.

Reference Type DERIVED
PMID: 26672982 (View on PubMed)

Other Identifiers

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1R01CA157824-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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