Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

December 14, 2021 updated by: Darren Mays, Georgetown University

Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers

The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 to 30 years
  • Smoke at least 100 cigarettes in their lifetime
  • Now smoke cigarettes on all or some days
  • Reside in the Washington, DC metro area
  • Willing to send and receive text messages on a personal mobile phone

Exclusion Criteria:

  • No additional exclusion criteria

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Loss-framed, branded
Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on branded packages.
Behavioral: Graphic cigarette warning labels, plain packaging
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
Experimental: Loss-framed, plain
Participants assigned to this arm use cigarette packs with loss-framed graphic warnings communicating the risks of smoking on plain or standardized packages.
Behavioral: Graphic cigarette warning labels, plain packaging
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
Experimental: Gain-framed, branded
Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on branded packages.
Behavioral: Graphic cigarette warning labels, plain packaging
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
Experimental: Gain-framed, plain
Participants assigned to this arm use cigarette packs with gain-framed graphic warnings communicating the benefits of quitting smoking on plain or standardized packages.
Behavioral: Graphic cigarette warning labels, plain packaging
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
No Intervention: Control
Participants assigned to this arm use their regular cigarette packs and complete study measures only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cigarette purchase appeal
Time Frame: Baseline
The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?
Baseline
Motivation to quit smoking
Time Frame: At the conclusion of the 4 week exposure
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
At the conclusion of the 4 week exposure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cigarette smoking behavior
Time Frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Cigarettes smoked per day is measured using a single valid question assessing about how many cigarettes participants smoked each day, on average.
At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Smoking quit attempts
Time Frame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Attempts to quit smoking is measured using a single valid item asking participants how many times they stopped smoking for 1 day or longer because they were trying to quit.
At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
Motivation to quit cigarette smoking.
Time Frame: At 1-month and 3-months post-exposure
Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.
At 1-month and 3-months post-exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-1031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will consider requests to share de-identified individual participant data by request and according to our study protocol and institutional data sharing policy.

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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