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Impact of Cigarette Pack Constituent Disclosures

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ClinicalTrials.gov Identifier: NCT02785484
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : June 8, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this randomized controlled trial is to determine whether constituent disclosures on cigarette packs increase intentions to quit smoking. Previous studies have been informative, but they have evaluated candidate graphic warnings, not constituent disclosures. Furthermore, they typically expose participants to messages in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of message exposure than found in the real world. This study addresses these issues by evaluating the impact of constituent disclosures by randomly assigning smokers to have their cigarette packs labeled with constituent disclosure messages or cigarette butt littering messages.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Behavior Other: Label with constituent disclosure message Other: Label with litter message Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Evaluating the Impact of Cigarette Pack Constituent Disclosures
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Label with constituent disclosure message Other: Label with constituent disclosure message
Labels with constituent disclosure messages that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 disclosures selected at random; at the week 3 visit, they will get one of the 2 remaining disclosures selected at random, and at the week 4 visit they will get the remaining disclosure. Study investigators developed the text and design of these labels.

Label with litter message Other: Label with litter message
Labels with litter messages that include text about littering cigarette butts will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 litter messages selected at random; at the week 3 visit, they will get one of the 2 remaining litter message selected at random, and at the week 4 visit they will get the remaining litter message. Study investigators developed the text and design of these labels.




Primary Outcome Measures :
  1. Quit intentions [ Time Frame: 4 weeks ]
    The primary outcome is quit intentions measured at 4 weeks by survey.


Secondary Outcome Measures :
  1. Awareness of health effects from smoking cigarettes [ Time Frame: 4 weeks ]
    Awareness of health effects will be measured at 4 weeks by survey.

  2. Awareness of cigarette smoke constituents [ Time Frame: 4 weeks ]
    Awareness of constituents will be measured at 4 weeks by survey.

  3. Quit attempts [ Time Frame: Up to 4 weeks ]
    Quit attempt will be measured during the 4 weeks of the study, reported at either 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.

  4. Successful Quitting [ Time Frame: 4 weeks ]
    Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.

  5. Forgoing a cigarette [ Time Frame: 4 weeks ]
    Forgoing a cigarette will be measured at 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less.

  6. Perceived likelihood [ Time Frame: 4 weeks ]
    Perceived likelihood of developing smoking-related health outcomes will be measured at 4 weeks by survey.

  7. Frequency of conversations about health messages [ Time Frame: 4 weeks ]
    Frequency of conversations with others about the health message on cigarette packs will be measured at 4 weeks by survey.

  8. Negative affective reactions [ Time Frame: 4 weeks ]
    Negative affect will be measured at 4 weeks by survey.

  9. Cognitive elaboration [ Time Frame: 4 weeks ]
    Cognitive elaboration (how much the participant reports thinking about the label) will be measured at 4 weeks by survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 21 years or older
  • Have smoked at least 100 cigarettes in his or her lifetime
  • Currently smoke cigarettes every day or some days
  • Currently smoke at least 7 cigarettes per week, on average
  • Be able to read and speak English
  • Be able to use a computer to take surveys
  • Be able to attend 5 weekly appointments
  • Be able to bring in 8 days' worth of cigarettes to each of the first 4 weekly appointments

Exclusion Criteria:

  • Smokers who smoke exclusively roll-your-own cigarettes
  • Pregnant women
  • Smokers concurrently enrolled in any research studies about smoking or using other tobacco products
  • Smokers who live in the same household as someone who has enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785484


Locations
United States, California
Ewald & Wasserman Research Consultants, LLC
San Francisco, California, United States, 94108
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Noel Brewer, PhD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02785484     History of Changes
Other Study ID Numbers: 12-2430
P50CA180907 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Cigarette smoking
Smoking
Tobacco use