Skip to main content
OpenTrials
Completed

NCT Number: NCT03446170

Effect of Cigarette Pack Warnings and Packaging 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Behavior Cigarette Smoking Smoking Tobacco Smoking

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graphic cigarette warning labels, plain packaging

Behavioral

This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging

Primary outcomes

  1. 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?

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2018
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.