NCT01782053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

January 29, 2013

Last Update Submit

December 1, 2014

Conditions

Lung CancerHeart Disease

Outcome Measures

Primary Outcomes (1)

  • Intention to try to quit smoking in next 30 days

    Assessed after 4 weeks of exposure to new labels

Secondary Outcomes (1)

  • Affective reactions toward cigarettes and smoking cues

    After 4 weeks of exposure to the new warning labels

Study Arms (3)

Control condition

EXPERIMENTAL

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

Behavioral: Control

Text plus picture

EXPERIMENTAL

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

Behavioral: Picture warning

Picture plus additional warning text

EXPERIMENTAL

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

Behavioral: Picture warning

Interventions

Picture warningBEHAVIORAL

Warning contains picture proposed for each text statement by FDA

Picture plus additional warning textText plus picture
ControlBEHAVIORAL
Control condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoke between 5 and 40 cigarettes per day and 100 in lifetime
  • Not currently trying to quit
  • between 18 and 65 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lazenby Hall, Ohio State University

Columbus, Ohio, 43210, United States

Location

Annenberg Public Policy Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 26672982DERIVED

MeSH Terms

Conditions

Lung NeoplasmsHeart Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCardiovascular Diseases

Study Officials

  • Daniel Romer, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Ellen Peters, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Adolescent Communication Institute

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(2)