- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075682
Cigarette Pack Inserts for Smoking Cessation
November 11, 2021 updated by: James Francis Thrasher, PhD, University of South Carolina
Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers
This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit.
To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs.
Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group.
Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches.
The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
387
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Ithaca, New York, United States, 14853
- Cornell University
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 or older
- Have smoked at least 100 cigarettes in their lifetime
- Smoked at least 10 cigarettes a day in the prior month.
Exclusion Criteria:
- Use of other nicotine products besides cigarettes in the prior month.
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard cigarette packs (control)
Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions.
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Experimental: Cigarette packs with inserts only
Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips).
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Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
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Experimental: Cigarette packs with pictorial warnings only
Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack.
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Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.
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Experimental: Cigarette packs with inserts and pictorial warnings
Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above).
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Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy to quit smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to quit smoking
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Evaluated approximately 4 times a day over the 14 day study period
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Worry about harms from smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single question measured on a continuous scale to assess strength of worry about harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated approximately 4 times a day over the 14 day study period
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Strength of feeling about smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single questions measured on a continuous scale to assess strength of positive to negative feelings about smoking (1="very BAD", good outcome; 7="very GOOD", worse outcome)
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Evaluated approximately 4 times a day over the 14 day study period
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Extent of motivation to quit smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated approximately 4 times a day over the 14 day study period
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Talk about smoking cessation
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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A single question to count the number of times the participant talked about smoking cessation or smoking-related harms in the prior 24 hours or the study period (depending on the analysis)
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Evaluated once each day (evening report) over the 14 day study period
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Foregoing a cigarette
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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Two questions combined to count whether the participant a) did not smoking a cigarette when they normally would or b) stubbed out a cigarette earlier than normal in the prior 24 hours or the study period (depending on the analysis)
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Evaluated once each day (evening report) over the 14 day study period
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Self-efficacy to cut down on smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked
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Evaluated approximately 4 times a day over the 14 day study period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength of hopefulness about quitting
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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A single question measured on a continuous scale to assess strength of feeling hopeful about quitting (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated approximately 4 times a day over the 14 day study period
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Extent of cognitive elaboration of smoking benefits
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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A single question measured on a continuous scale to assess the frequency of thinking about the positive things about smoking (1="Not at all", better outcome; 7="Extremely", worse outcome)
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Evaluated once each day (evening report) over the 14 day study period
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Extent of cognitive elaboration of smoking harms
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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A single question measured on a continuous scale to assess the frequency of thinking about the harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated once each day (evening report) over the 14 day study period
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Extent of cognitive elaboration of cessation benefits
Time Frame: Evaluated once each day (evening report) over the 14uestion measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1="Not at all", worse outcome; 7="Extre day study period
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A single question measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated once each day (evening report) over the 14uestion measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1="Not at all", worse outcome; 7="Extre day study period
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Strength of beliefs about benefits of smoking cessation (i.e., response efficacy)
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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A single question measured on a continuous scale to assess the strength of perceived benefits from cessation (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated once each day (evening report) over the 14 day study period
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Strength of perceived susceptibility to smoking harms
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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A single question measured on a continuous scale to assess the perceived likelihood of suffering harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome)
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Evaluated once each day (evening report) over the 14 day study period
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Expressed reactance against health messages
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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Binary measure of talking about how health information on packs is useless or not believable in the prior 24 hours or over the study period (depending on the analysis)
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Evaluated once each day (evening report) over the 14 day study period
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Cigarettes per day
Time Frame: Evaluated each day over the 14 day study period, using daily reports and participant logging of cigarettes
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Continuous variable for the number of cigarettes smoked each day
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Evaluated each day over the 14 day study period, using daily reports and participant logging of cigarettes
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Satisfaction from smoking
Time Frame: Evaluated approximately 4 times a day over the 14 day study period
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Single question measured on a continuous scale that assesses strength of satisfaction from smoking (1="Not at all", better outcome; 7="Extremely", worse outcome)
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Evaluated approximately 4 times a day over the 14 day study period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversation partners
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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Nominal variable indicating the types of people with whom people talked about smoking and cessation in the prior 24 hours
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Evaluated once each day (evening report) over the 14 day study period
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Conversation topics
Time Frame: Evaluated once each day (evening report) over the 14 day study period
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Nominal variable indicating the topics of conversation around smoking in the prior 24 hours
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Evaluated once each day (evening report) over the 14 day study period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James F Thrasher, PhD, University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
June 29, 2021
Study Completion (Actual)
June 29, 2021
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
September 3, 2019
Study Record Updates
Last Update Posted (Actual)
November 12, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Pro00083728
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We are likely to make participant data to researchers who make specific requests and have specific data analysis plans that we approve.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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