Clinical trial NCT03446170: Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers
Official title: Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Young adults
Cigarette smoking
Warning labels
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cigarette purchase appeal
timeFrame: Baseline
measure: Motivation to quit smoking
timeFrame: At the conclusion of the 4 week exposure
Secondary outcomes:
measure: Cigarette smoking behavior
timeFrame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
measure: Smoking quit attempts
timeFrame: At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure
measure: Motivation to quit cigarette smoking.
timeFrame: At 1-month and 3-months post-exposure
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Darren Mays, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.