Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers

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: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Graphic cigarette warning labels, plain packaging

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: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cigarette purchase appeal	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	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

Outcome Measure	Measure Description	Time Frame
Cigarette smoking behavior	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	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.	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

• Sponsor: Georgetown University

Publications and helpful links

General Publications

• Johnson AC, Luta G, Tercyak KP, Niaura RS, Mays D. Effects of pictorial warning label message framing and standardized packaging on cigarette packaging appeal among young adult smokers. Addict Behav. 2021 Sep;120:106951. doi: 10.1016/j.addbeh.2021.106951. Epub 2021 Apr 13.
• Johnson AC, Turner MM, Simmens SJ, Evans WD, Strasser AA, Mays D. Mediational Effects on Motivation to Quit Smoking After Exposure to a Cigarette Pictorial Warning Label Among Young Adults. Ann Behav Med. 2022 Jul 12;56(7):737-748. doi: 10.1093/abm/kaab073.
• Johnson AC, Simmens SJ, Turner MM, Evans WD, Strasser AA, Mays D. Longitudinal effects of cigarette pictorial warning labels among young adults. J Behav Med. 2022 Feb;45(1):124-132. doi: 10.1007/s10865-021-00258-2. Epub 2021 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Young adults; Cigarette smoking; Warning labels
• Other Study ID 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