Skip to main content
OpenTrials
Completed

NCT Number: NCT01782053

Communicating Smoking Risks Through Graphic Warning Labels

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Cardiovascular Diseases Heart Disease Heart Diseases Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lazenby Hall, Ohio State University, Columbus, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Picture warning

Behavioral

Warning contains picture proposed for each text statement by FDA

Control

Behavioral

Primary outcomes

  1. Intention to try to quit smoking in next 30 days

    Time frame: Assessed after 4 weeks of exposure to new labels

Secondary outcomes

  1. Affective reactions toward cigarettes and smoking cues

    Time frame: After 4 weeks of exposure to the new warning labels

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Ohio State University

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.