An interventional study of Graphic cigarette warning labels, plain packaging in Tobacco Use, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Georgetown University · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
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
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
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
Participants assigned to this arm use their regular cigarette packs and complete study measures only.
This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
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?
Time frame: 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.
Time frame: At the conclusion of the 4 week exposure
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.
Time frame: 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.
Time frame: 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.
Time frame: At 1-month and 3-months post-exposure
Plan to share: Undecided — We will consider requests to share de-identified individual participant data by request and according to our study protocol and institutional data sharing policy.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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