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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03446170
Enrollment
400
Registered
2018-02-26
Start date
2014-09-01
Completion date
2020-08-31
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

Young adults, Cigarette smoking, Warning labels

Brief summary

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.

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.

Interventions

BEHAVIORALGraphic 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

Sponsors

Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Masking description

The study tests the effects of graphic cigarette warning labels and packaging regulations, therefore it is unmasked.

Intervention model description

The experimental design is a 2 (graphic warning message framing: gain versus loss) by 2 (cigarette packaging: standardized, plain or branded) factorial design. An unexposed control group is also included.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cigarette purchase appealBaselineThe 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?
Motivation to quit smokingAt the conclusion of the 4 week exposureMotivation 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.

Secondary

MeasureTime frameDescription
Cigarette smoking behaviorAt the conclusion of the 4 week exposure, and at 1- and 3-months post-exposureCigarettes smoked per day is measured using a single valid question assessing about how many cigarettes participants smoked each day, on average.
Smoking quit attemptsAt the conclusion of the 4 week exposure, and at 1- and 3-months post-exposureAttempts 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.
Motivation to quit cigarette smoking.At 1-month and 3-months post-exposureMotivation 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026